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How Tight Jeans, Childhood Obesity Fuel Infertility, By Medical Experts

August 14, 2012 No comments

How Tight Jeans, Childhood Obesity Fuel Infertility, By Medical Experts
Tight jeans have been discovered to cause bladder problems, testicular torsion and damage sperm production; and childhood obesity triggers early onset of puberty, leading to a diminished ability to reproduce – particularly in women. Medical experts, in …
Read more on The Guardian Nigeria

Reality a far cry from The Shire
Perhaps all that negative publicity will continue though when Puberty Blues, also shot in The Shire, starts on Ten soon? Provan is having none of that. "Puberty Blues is a television series and not reality television," she argued. As far as Provan is …
Read more on Herald Sun

Babes and bucks, sex and sleaze
Puberty Blues a 1970s shagfest involving panel vans ("If this van's rockin', don't bother knockin"), chiko rolls and deadset surfer molls dominated the public image of Sydney's Sutherland Shire for decades. In Puberty Blues, written by Kathy Lette and …
Read more on Adelaide Now

JBNI’s 100 Percent Herbal Bioprin Formula Demonstrates High Anti-cancer Tumor Efficacy at Dana Farber Cancer Institute / Harvard Medical School

August 11, 2012 No comments

Canyon Park, WA (PRWEB) July 31, 2008

The following press release is provided to Cancer researchers only and is to be used only as data for scientific research purposes.

JBNI today released a Dana-Farber Cancer Institute / Harvard Medical School (DFCI/HMS) anti-tumor activity report regarding Formula 15.3 (Bioprin) by Dr. Beverly A. Teicher’s and her team. The report entitled, “Efficacy of orally administered herb preparations against the EMT-6/Parent Tumor,” clinically documents the effect of JBNI’s all-herbal formula on the “equivalent to human metastatic breast cancer.” The report illustrates the potential of naturally occurring herbs for use in clinical / medical applications.

In the summary by Dr. Marianne Spada, Ph.D., the doctor notes that, “JJ-15.3 shows at the dose of 500mg/kg a TGD of 4.15 plus or minus 0.53, which is much more potent than (common chemotherapeutic agents) Melpahlan (2.3tgd) or Carmustine (2.5tgd), and comparable to radiotherapy or Cysplatin in treatment of metastatic cancer.” Dr. Spada goes on to project, “With higher dose and more frequency than current testing (14 days dose), we might observe much greater TGD than current result even with the current level of herbal concentration.”

A full test result spread sheet was also just released. It is entitled, “Tumor growth delay of Herbal Mixture JJ-15.3 in the EMT-6 Murine Marrary Carcinoma at 500mm cubed.” In it, the total anti-tumor effect when supporting x-ray radiation therapy (1 wk at 300 rads = 4.3tgd) with JBNI’s Formula 15.3 is shown to be 5.15tgd plus or minus 0.61.

When asked about the aggressive nature of 15.3′s effect on cancer cells and potential safety issues, JBNI Investor Relations Manager, Ken Case quoted Dr. Teicher’s report saying, “Formula 15.3 has already been on the market as Bioprin for about 15 years as a relaxant and herbal formula for comfort and ease. It is totally herbal, pesticide free, and 100% natural. Besides, the Dana-Farber Cancer Institute / Harvard document clearly says,’There are no signs of toxicity with this herbal mixture.’”

Calling Formula 15.3 a, “remarkable compound,” Dr. Teicher’s report expresses a desire for further study, “to observe how related organs are responding to delay tumor growth so powerfully without any harm as we see in the current testing.”

The DFCI/HMS report concludes, “Different stages of tumor, tumor preventive tests and other types of metastatic cencer should be further studied with this remarkable compound.”

Inspite of the above findings on Bioprin’s all natural formula that uses strictly pesticide free herbal ingredients, JBNI strictly advises against using Bioprin outside of the care of a Board Certified Physician. A JBNI PR representative, Azim Walli states, “anti-tumor efficacy, even under proven invivo conditions, cannot replace the expertise and experience of a trained cancer specialist’s supervision of time tested FDA approved drugs.”

Official copies of the DFCI/HMS document may be requested from JBNI Inc. located in the biotech community of Canyon Park, Wa.

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Related Carcinoma Press Releases

Antipsychotic Medications Cause Substantial Weight Gain in Children and Adolescents, According to Scientists at the Feinstein Institute for Medical Research and Zucker Hillside Hospital

August 10, 2012 No comments

Manhasset , NY (Vocus) October 28, 2009

It has been known for several years that antipsychotic medications can cause weight gain in adults and increase the risk for serious metabolic disorders. Scientists at The Zucker Hillside Hospital and The Feinstein Institute for Medical Research embarked on a large study following children and adolescents who have been prescribed antipsychotic medicines for the first time and examining the impact they had on weight gain and metabolic changes. Indeed, researchers identified a worrisome degree of weight gain and caution their colleagues to take these changes seriously. Weight gain and changes in blood glucose and lipid metabolism can be precursors of diabetes, hypertension, metabolic syndrome, stroke and heart attack. The children tested were between 4-19 years old.

“The data sheds further light on the frequency and severity of weight gain associated with these newer antipsychotics,” said Christoph U. Correll, MD, medical director of the Recognition and Prevention (RAP) program at the Zucker Hillside Hospital and a scientist in the Feinstein Institute’s Center for Psychiatric Neuroscience. “Our findings suggest increased caution in prescribing them to pediatric patients.”

The scientists studied 272 young people who had been prescribed antipsychotic medicines for a range of serious behavioral, mood and psychosis-related problems. The patients were prescribed one of a number of second-generation antipsychotics and followed over the first 12 weeks to assess changes in weight, blood glucose and lipids. At around 11 weeks, the young patients had gained an average of 19 pounds on the antipsychotic, olanzapine; 13.5 pounds on quetiapine; 11.9 pounds on risperidone; and 9.9 pounds on aripiprazole. By comparison, 15 patients who refused participation in the study or were not compliant with taking the antipsychotics were used as a control group and their weight gain during the same study period was less than a half-pound.

The findings were published this week in the Journal of the American Medical Association (JAMA).

The scientists also identified substantial changes in triglycerides and cholesterol, and found that the weight gain alone did not seem to explain entirely the adverse metabolic effects that varied significantly across the individual medications. All of the findings, Dr. Correll said, “should be considered when choosing antipsychotics.” SATIETY (Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth) is the largest cohort study of atypical antipsychotic treatment in children and adolescents treated with antipsychotics. It is also the largest study of its kind in children or adults who received antipsychotic treatment for the first time in their life. This is a key study feature because prior treatment can obscure the true cardiometabolic effects of medications. In the SATIETY study, the antipsychotic-na?ve youths suffered from a range of problems, including psychosis (30.1 percent,) mood disorders (47.8 percent) and aggressive behavior (22.1 percent). Researchers followed these patients to understand if weight and metabolic changes are due to the new onset of a psychiatric illness or related hospital admission, or whether the observed changes are effects of the antipsychotic treatment.

The scientists found that the worsening of metabolic parameters differed between the antipsychotic medications groups, despite the shared, large and significant changes in body weight parameters, including waist circumference. Olanzapine, which was also associated with the largest effects on body weight, was associated with the greatest and most widespread worsening of lipid as well as glucose parameters. Quetiapine and risperidone were associated with varying degrees of lipid abnormalities only, which were more pronounced with quetiapine. By contrast, aripiprazole was not associated with any significant worsening in glucose or lipid parameters, which was also the case in the comparison subjects. “These findings provide further evidence for an additional, weight independent mechanism for glucose and lipid abnormalities with olanzapine that does not seem to be shared by the other antipsychotics that were studied,” said Dr. Correll.

Antipsychotic medication use in young people has grown substantially in recent years and this study calls into question the effects of this upward trend. “Abnormal childhood weight and metabolic status adversely affect adult cardiovascular outcomes via continuation of these risk factors or independent or accelerated mechanisms,” the scientists wrote. “Our results, together with data from first-episode studies, suggest that guidelines for antipsychotic medication exposure for vulnerable pediatric and adolescent patients naive to antipsychotic medication should consider more frequent (e.g., biannual) cardiometabolic monitoring after the first three months of treatment. Finally, in view of poor physical health outcomes and suboptimal metabolic monitoring in the severely mentally ill, the benefits of second-generation antipsychotic medications must be balanced against their cardiometabolic risks through a careful assessment of the indications for their use, consideration of lower-risk alternatives, and proactive adverse effect monitoring and management.”

In an accompanying editorial, Christopher K. Varley, M.D., and Jon McClellan, M.D., of Seattle Children’s Hospital, said that while “these medications can be lifesaving for youth with serious psychiatric illnesses such as schizophrenia, classically defined bipolar disorder, or severe aggression associated with autism,” and “given the risk for weight gain and long-term risk for cardiovascular and metabolic problems, the widespread and increasing use of atypical antipsychotic medications in children and adolescents should be reconsidered.”

About The Feinstein Institute for Medical Research

Headquartered in Manhasset, NY, The Feinstein Institute for Medical Research is home to international scientific leaders in cancer, leukemia, lymphoma, Parkinson’s disease, Alzheimer’s disease, psychiatric disorders, rheumatoid arthritis, lupus, sepsis, inflammatory bowel disease, diabetes, human genetics, neuroimmunology, and medicinal chemistry. Feinstein researchers are developing new drugs and drug targets, and producing results where science meets the patient, annually enrolling some 10,000 subjects into clinical research programs.

About The Zucker Hillside Hospital

The Zucker Hillside Hospital is home to many of the nation’s experts on severe mental illness. In addition to treating patients in and out of the hospital, psychiatric research has been ongoing for decades and includes landmark studies on the treatment and course of first-episode psychotic patients. Genetics also plays a critical role in severe mental illness and scientists at the Zucker Hillside Hospital have identified several important risk genes. John Kane, MD, chair of psychiatry at Zucker Hillside, and his team of scientists recently received a $ 26 million federal grant to train psychiatric staff across the country to deliver state-of-the-art treatments for patients with a first episode of schizophrenia and to test whether it works to delay or alter the disabling course of the illness.

Contact: Jamie Talan

science writer-in-residence

516-562-1232 or 631-682-8781 (cell)

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Audio-Digest Releases 17 New Specialty-Specific Continuing Medical Education Programs

August 10, 2012 No comments

Glendale, CA (PRWEB) April 22, 2011

Audio-Digest Foundation announced today 17 new issues of Continuing Medical Education (CME) audio programs covering 15 medical specialties including Anesthesiology, Emergency Medicine, Family Practice, Gastroenterology, General Surgery, Internal Medicine, Neurology, Obstetrics & Gynecology, Oncology, Ophthalmology, Orthopaedics, Otolaryngology, Pediatrics, Psychiatry, and Urology.

Anesthesiology CME: Audio-Digest Anesthesiology Volume 53, Issue 07 Subject:????Perioperative Use of Statins

Goal:????The goal of this program is to improve operative outcomes via the appropriate use of statins.

Program:

From the 2011 UCSD, School of Medicine Anesthesiology Update Conference

Dr. John C. Drummond, MD, Professor of Anesthesiology, UCSD, School of Medicine, and Staff Anesthesiologist, Veterans Affairs Medical Center, San Diego

Emergency Medicine CME: Audio-Digest Emergency Medicine Volume 28, Issue 07 Subject:????Pneumonia

Goal:????To improve the management of pneumonia.

Program:

The Assessment and Treatment of Severe Pneumonia ? From Current Management in Critical Care, sponsored by Kansas City Southwest Clinical Society, Dr. Marin H. Kollef, MD, Golman Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO

Family Practice CME: Audio-Digest Family Practice Volume 59, Issue 13

Subject:????The Impaired Airway: Guidelines on Management

Goal:????To improve management of airway disorders and chronic cough.

Program:

From the Interstate Postgraduate Medical Association of North America?s 2010 Primary Care Update, Dr. Mark S. Regan, MD, Associate Professor of Medicine, University of Wisconsin School of Medicine and Public Health, Madison

Family Practice CME: Audio-Digest Family Practice Volume 59, Issue 14

Subject:????Otolaryngology in Primary Care

Goals:????To improve management of common otolaryngologic problems and Bell palsy.

Program:

1.????Office Otolaryngology — Dr. Paul A. Kedeshian, MD, Associate Clinical Professor, Di- vision of Head and Neck Surgery, David Geffen School of Medicine at UCLA

2. Bell Palsy — Dr. Gary Klein, MD, Clinical Associate Professor, Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary, AB

Gastroenterology CME: Audio-Digest Gastroenterology Volume 25, Issue 02

Subject:????Liver Disease Part 2: Ascites and Transplantation

Goal:????To improve the management of refractory ascites and the evaluation of patients for liver transplantation (LT).

Program:

1.????Refractory Ascites — Dr. Joseph Awad, MD, Associate Professor of Medicine and Pharmacology, Vanderbilt University School of Medicine, Nashville, TN

2. Evaluation of Candidates for Liver Transplantation — Dr. Adrian Ruben, MBBS, Professor of Medicine, Medical University of South Carolina, Charleston

General Surgery CME: Audio-Digest General Surgery Volume 58, Issue 07 Subject: Inflammatory Bowel Disease

Goal:????To improve the surgical man- agement of inflammatory bowel disease.

Program:

1.????Ulcerative Colitis: Preparing for Colectomy — Dr. Sonia L. Ramamoorthy, MD, Assistant Professor of Surgery, University of California, San Diego, School of Medicine

2.????Medical Treatment to Optimize Surgery — Dr. Michael J. Docherty, MD, Assistant Clinical Professor, Department of Medicine, University of California, San Diego, School of Medicine

3.????Surgical Strategies for Complex Perianal Crohn Disease — Dr. Elisabeth McLemore, MD, Assistant Professor of Surgery, University of California, San Diego, School of Medicine

Internal Medicine CME: Audio-Digest Internal Medicine Volume 58, Issue 13

Subject: Men’s Health

Goal:????To improve the diagnosis and management of benign prostatic hyperplasia (BHP) and lower urinary tract symptoms (LUTS), and testosterone deficiency.

Program:

1.????Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms — Dr. Edward M. Schaeffer, MD, PhD, Assistant Professor of Urology, Oncology, and Pathology; Director, International Urology; Co-director, Prostate Cancer Multi-Disciplinary Clinic, Johns Hopkins Medical Institutions, Baltimore, MD

2.????Testosterone Deficiency — Dr. J. Bruce Redmon, MD, Associate Professor, Departments of Medicine and Urologic Surgery, University of Minnesota Medical School, Minneapolis

Internal Medicine CME: Audio-Digest Internal Medicine Volume 58, Issue 14 Subject: Topics In Neurology

Goals:????To improve the identification and initial office management of neurosurgical emergencies, and the diagnosis and treatment of severe headaches (HA).

Program:

1.????Office-Based Neurosurgical Emergencies — Dr. Robert T. Tenny, MD, Neurological Surgeon, Overland Park Regional Medical Center, Overland Park, KS

2.????Severe Headaches — Dr. Douglas Dulli, MD, Professor, Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison

Neurology CME: Audio-Digest Neurology Volume 02, Issue 07 Subject: Migraine: Communicating With Patients

Goal:????To improve the management of patients with migraines.

Program:

1.????Acute Treatment of Migraine — Dr. Mark W. Green, MD, Professor of Neurology and Anesthesiology, Director of Headache and Pain Medicine, Mt. Sinai School of Medicine, New York, NY

2.????Preventive Therapy for Migraine — Dr. Roger K. Cady, MD, Director, Headache Care Center, Springfield, MO.

Obstetrics & Gynecology CME: Audio-Digest Obstetrics & Gynecology Volume 58, Issue 07 Subject:????Update on Thyroid Disorders

Goal:????To improve the recognition and management of thyroid disorders.

Program:

1. Thyroid Disorders — Dr. Fiona J. Cook, MD, Clinical Associate Professor, Division of Endocrinology, Department of Internal Medicine, East Carolina University, Brody School of Medicine, Greenville, NC

2. Hypothyroidism: Case Histories — Dr. Veronica K. Piziak, MD, PhD, Professor of Medicine and Endocrinology, and Director Emeritus, Division of Endocrinology, Department of Medicine, Texas A&M University Health Science Center, College of Medicine, College Station, TX

Oncology CME: Audio-Digest Oncology Volume 02, Issue 07

Subject:????Gynecologic Cancers

Goal:????To improve the management of gynecologic cancers.

Program:

1.????New Directions in Chemotherapy and Biologic Therapy for Epithelial Ovarian Cancer — Dr. Jonathan A. Ledermann, MD, Professor of Medical Oncology and Director, Cancer Research United Kingdom and University College London Cancer Trials Centre, UCL Cancer Institute, London, England

2.????Role of Chemotherapy in Cervical Cancer — Dr. Michael A. Quinn, MD, Professor of Gynecologic Oncology, University of Melbourne and Royal Women?s Hospital, Frances Perry House, Parkville, Victoria, Australia

3.????Chemoradiation for Endometrial Cancer — Dr. Akila Viswanathan, MD, MPH, Associate Professor of Radiation Oncology, Harvard Medical School, and Director of Gynecologic Radiation Oncology at Dana Farber/Brigham and Women’s Cancer Center, Boston, MA

Ophthalmology CME: Audio-Digest Ophthalmology Volume 49, Issue 07

Subject:????Anterior Segment Surgery

Goal:????To improve outcomes of surgery for astigmatism and implantation of presbyopia-correcting intraocular lenses (IOLs).

Program:

1.????Correction of Astigmatism in Association with Cataract Surgery — Dr. Bonnie An Henderson, MD, Assistant Clinical Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA

2.????Managing Complications of Presbyopia-correcting Intraocular Lenses — Dr. Henderson

Orthopaedics CME: Audio-Digest Orthopaedics Volume 34, Issue 07

Subject:????Shoulder Surgery

Goals:????To improve the management of rotator cuff tears (RCT) and other shoulder conditions and to implement new techniques and technologies to improve patient and surgical outcomes.

Program:

1.????Partial Thickness Rotator Cuff Tears: Observe or Operate? — Dr. Ian K. Lo, MD, Assistant Professor, University of Calgary Faculty of Medicine, Calgary, AB

2.????Anterosuperior Rotator Cuff Tears — Dr. Jeffrey S. Abrams, MD, Clinical Associate Professor, Department of Orthopaedic Surgery, Seton Hall School of Graduate Medical Education, South Orange, NJ, and Attending Surgeon, University Medical Center, Princeton, NJ

3.????Suprascapular Neuropathy: How Common Is It? — Dr. Jon J.P. Warner MD, Professor of Orthopaedic Surgery, Harvard Medical School, and Chief, Harvard Shoulder Service, Massachusetts General Hospital and the Brigham and Women’s Hospital, Boston

4.????Examination of the Painful Shoulder — Dr. Armodios M. Hatzidakis, MD, Orthopaedic Shoulder and Elbow Specialist, Presbyterian/St. Luke? s Medical Center, Denver, CO

Otolaryngology CME: Audio-Digest Otolaryngology Volume 44, Issue 07 Subject:????Otology Update

Goal:????To improve the management of otologic disorders.

Program:

1.????Quick Approach to Tinnitus, Vertigo, and Sudden Sensorineural Hearing Loss — Dr. Sujana Chandrasekhar, MD, Clinical Associate Professor of Otolaryngology, Mt. Sinai School of Medicine, New York, NY; Director, New York Otology; and Chair-Elect, Board of Governors, American Academy of Otolaryngology?Head and Neck Surgery

2.????Principles of Tympanomastoidectomy — Dr. Saumil N. Merchant, MD, Eliasen Professor of Otology and Laryngology, Harvard Medical School; Surgeon in Otolaryngology, Director of Otopathology Laboratory, and Co-director of the Wallace Middle Ear Research Unit, Massachusetts Eye and Ear Infirmary, Boston, MA

3.????Evolution of Auditory Implants — Dr. Harold C. Pillsbury MD, Thomas A. Dark Distinguished Professor and Chair of Otology ? Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill

Pediatrics CME: Audio-Digest Pediatrics Volume 57, Issue 07

Subject:????Challenges In Ethics

Goal:????To improve ethical decision making in cases of refusal of medical care.

Program: Treatment Refusal in the Pediatric Outpatient Setting: Do Parents Know Best?

1.????Surrogate Decision Making

2.????Role of Adolescent in Medical Decision Making

3.????Overriding Adult Refusal

4.????Presented by Dr. Lainie Friedman Ross, MD, PhD, Carolyn and Matthew Bucksbaum Professor of Clinical Ethics, Professor, Departments of Pediatrics, Medicine, and Surgery, and Associate Director, MacLean Center for Clinical Medical Ethics, University of Chicago Medical Center, Chicago, IL

Psychiatry CME: Audio-Digest Psychiatry Volume 40, Issue 07 Subject:????Migraine

Goal:????To improve the management of migraine headaches, with emphasis on those that occur in individuals with mood disorders.

Program:

1.????Psychiatric Management of Migraine and Mood Disorders — Dr. Robert B. Shulman, MD, Assistant Professor, Rush Medical College, Rush University Medical Center, Chicago, IL

2.????Overview of Migraine — Dr. Roger K. Cady, MD, Director, Headache Care Center, Springfield, MO

Urology CME: Audio-Digest Urology Volume 34, Issue 07 Subject:????Prostate Challenges

Goal:????To improve the management of prostate cancer.

Program:

1.????Answers to Board Review Questions — Dr. Judd W. Moul, MD, Director, Duke Prostate Center, James H. Semans, MD, Professor of Surgery and Chief, Urologic Surgery, Duke University, Durham, NC

2.????Cryotherapy After Failure of External Radiation Therapy — Dr. Peter T. Nieh, MD, Associate Professor of Urology, Emory University School of Medicine, Atlanta, GA

Audio-Digest Foundation is a Learner’s Digest International business, as well as an affiliate of the California Medical Association. Its mission is to provide high-quality, convenient, and affordable continuing professional education to physicians and other healthcare professionals so they can meet the growing requirements to learn and to improve patient care, thereby promoting/enhancing the health of the general public.

Its ongoing initiatives are to:

????????Uncover new educational resources;

????????Investigate new communications technology; and

????????Develop new educational programming aimed at improving patient care and enhancing the public health.

Every year, Audio-Digest Foundation records over 9,000 hours of presentations by the leading medical researchers at the top universities and research institutions and publishes over 800 programs in 17 specialties. Tens of thousands of doctors, residents, physician assistants, nurses and other healthcare providers count on Audio-Digest to help them remain current in their education and satisfy their CME/CE requirements.

All Audio-Digest programs can be used for credit or contact hours by physicians, physician-assistants, and nurses. As well, particular Audio-Digest programs can be used for credit or contact hours by certified registered nurse anesthetists, psychologists, optometrists, ophthalmic technicians, certified diabetes educators, and registered dietitians or dietetic technicians, registered.

The Audio-Digest Foundation is accredited by the Accreditation Council For Continuing Medical Education to provide continuing medical education for physicians.

The Audio-Digest Foundation designates each enduring material for a maximum of 2 AMA PRA Category1 CreditsTM.* Physicians should claim only the credit commensurate with the extent of their participation in the activity.

*Exception: Each ACCEL program is designated for a maximum of 4 AMA PRA Category1 creditsTM.

In adherence to ACCME Standards for Commercial Support, Audio-Digest requires that all faculty and members of the planning committee who have been involved in an ADF activity have disclosed relevant financial relationships within the past 12 months that might create any personal conflicts of interest. Audio-Digest Foundation ensures that all identified conflicts have been resolved prior to publication to ensure that the educational activity promotes quality in health care and not a proprietary business or commercial interest.

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Five New Studies at Major Medical Meeting Further Demonstrate Clinical Experience for JANUVIA? (sitagliptin)

August 09, 2012 No comments

WHITEHOUSE STATION, N.J. (PRWEB) September 9, 2008

WHITEHOUSE STATION, N.J. (Business Wire EON) September 9, 2008 — New data analyses presented at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) showed initial combination therapy with the dipeptidyl peptidase-4 (DPP-4) inhibitor, JANUVIA? (sitagliptin), and metformin provided improvements in blood sugar levels (as measured by A1C1) over two years of treatment and was generally well tolerated. Also presented at the meeting was a separate, new pooled analysis of 6,139 patients that showed that JANUVIA was generally well tolerated in clinical trials up to two years in duration.

JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in combination with insulin. JANUVIA is contraindicated for patients with history of a serious hypersensitivity reaction to sitagliptin, including anaphylaxis and angiedema.

More than six million total prescriptions for JANUVIA have been dispensed worldwide since launch. JANUVIA has received approval in 80 countries and is available in every region around the world. The U.S. Food and Drug Administration approved JANUVIA in October 2006 and the European Medicines Agency (EMEA) approved JANUVIA in Europe in April 2007.

Initial combination of JANUVIA and metformin provided glycemic improvements out to two years

In a study of initial combination therapy with JANUVIA and metformin, glucose-lowering was assessed by measuring the mean change from baseline A1C levels at one year and two years. The mean A1C reductions from baseline in this study were 1.8 percent at one year (n=153) in patients treated with JANUVIA 50 mg/metformin 1000 mg twice-daily. In the extension study at two years, the mean A1C reduction was 1.7 percent (n=105; baseline A1C of 8.6 percent) for this group. Additionally, mean A1C reductions from baseline were 1.4 percent (at one year, n=147 and two years, n=96) in patients treated with JANUVIA 50 mg/metformin 500 mg twice daily, 1.3 percent (at one year, n=134 and two years, n=87) in patients treated with metformin 1000 mg twice daily, 1.0 percent (at one year, n=117) and 1.1 percent (at two years, n=64) in patients treated with metformin 500 mg twice daily. For patients treated with JANUVIA, there was a 0.8 percent reduction in A1C levels from baseline at one year (n=106) and a 1.2 percent reduction from baseline at two years (n=50).

Initial combination therapy or maintenance of combination therapy should be individualized and are left to the discretion of the health care provider.

Three additional studies further demonstrated the safety and efficacy profile of JANUVIA as an add-on to other oral diabetes treatments and efficacy when analyzed based on different baseline characteristics

In one 52-week investigational study, addition of JANUVIA to the combination of metformin and rosiglitazone significantly improved glycemic control in patients with type 2 diabetes. In a separate 52-week study of Japanese patients using an investigational dosing regimen, treatment with JANUVIA added to ongoing pioglitazone therapy provided effective glycemic control and was generally well tolerated with a comparable occurrence of hypoglycemia in the placebo and JANUVIA (50 mg, once daily) groups, and without clinically meaningful change in body weight. A mean change in A1C from baseline of 0.7 percent was observed; 62 percent of patients achieved A1C less than seven percent in the JANUVIA population at the end of the 52-week period.

“These data are interesting for physicians treating type 2 diabetes as they provide data regarding the clinical efficacy of JANUVIA both as initial combination therapy with metformin and also as add on therapy to other commonly used oral diabetes medications,” said Professor Bernard Charbonnel, professor of Endocrinology and Metabolic Diseases, University of Nantes and Head of the Internal Medicine, Endocrinology and Diabetes Department, H?tel Dieu (University Hospital of Nantes). “This is important for patients and physicians because type 2 diabetes is characterized by a progressive deterioration in beta cell function over time, resulting in the disease worsening. This progression of disease leads to decreased effectiveness of all known treatments over time, with patients often requiring multiple therapies in order to achieve their glycemic goals.”

An additional analysis presented at the meeting demonstrated that in patients with type 2 diabetes, JANUVIA provided glycemic control regardless of baseline characteristics of age, gender, BMI, HOMA-?, and P/I ratio.

In controlled clinical studies for JANUVIA as both monotherapy and combination therapy with metformin or pioglitazone, the overall incidence of adverse reactions, hypoglycemia, and discontinuation of therapy due to clinical adverse reactions with JANUVIA were similar to placebo. In these clinical studies, the most common adverse reactions reported with JANUVIA (greater than or equal to five percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection and headache. In clinical trials in combination with a sulfonylurea (glimepiride), with or without metformin, JANUVIA demonstrated an overall incidence of adverse reactions higher than that seen with placebo, in part related to a higher incidence of hypoglycemia.

As is typical with other anti-hyperglycemic agents used in combination with a sulfonylurea, when JANUVIA is used in combination with a sulfonylurea, a class of medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia.

Initial combination of JANUVIA and metformin: study design and results

Initial combination therapy with JANUVIA and metformin significantly improved blood sugar levels compared with either metformin or JANUVIA alone over two years of treatment. After completing the initial, double-blind 54-week base study, 412 patients who received active treatment throughout the study were included in the all-patients-treated analysis of efficacy at two years.

The mean A1C reduction from baseline in the 1-year base study was 1.8 percent (n=153) in patients treated with JANUVIA 50 mg/metformin 1000 mg twice daily. In the extension study at two years, the mean A1C reduction from baseline was 1.7 percent (n=105) in this group of patients. Additionally, mean A1C reductions from baseline were 1.4 percent (at one year, n=147 and two years, n=96) in patients treated with JANUVIA 50 mg/metformin 500 mg twice daily, 1.3 percent (at one year, n=134 and two years, n=87) in patients treated with metformin 1000 mg twice daily, 1.0 percent (at one year, n=117) and 1.1 percent (at two years, n=64) in patients treated with metformin 500 mg twice daily. For patients treated with JANUVIA, there was a 0.8 percent reduction in A1C levels from baseline at one year (n=106) and a 1.2 percent reduction from baseline at two years (n=50).

Pooled analysis of safety and tolerability of JANUVIA: study design and results

In a pooled analysis of clinical studies up to two years in duration, treatment with JANUVIA was found to be generally well tolerated, with generally similar incidence of adverse experiences in patients treated with JANUVIA relative to those not exposed to JANUVIA.

The safety and tolerability of JANUVIA were evaluated by pooling data from 12 large, double-blind, randomized, completed Phase IIb and III studies of 18-weeks to two years duration that included 6,139 patients receiving either JANUVIA once-daily (n=3,415) or placebo or an active comparator (n=2,724; non-exposed group). The studies assessed JANUVIA as monotherapy, initial combination therapy with metformin or add-on therapy to oral antihyperglycemic agents (metformin, pioglitazone, a sulfonylurea, a sulfonylurea plus metformin or metformin plus rosiglitazone). Patients not receiving JANUVIA received a range of treatments, including placebo, pioglitazone, metformin, a sulfonylurea, a sulfonylurea plus metformin, or metformin plus rosiglitazone. This comparison group, patients not receiving JANUVIA, is referred to as the “non-exposed” group.

For clinical adverse experiences (AEs), the incidence of AEs overall, serious AEs and discontinuations due to AEs were similar between the JANUVIA and non-exposed groups. The incidence of drug-related AEs and discontinuations due to drug-related AEs were higher in the non-exposed group primarily due to events of hypoglycemia in sulfonylurea-treated patients.

Clinical AEs that occurred at a higher incidence in the sitagliptin group and for which the 95 percent confidence intervals around the between-group difference excluded zero were as follows: atrial fibrillation, asthenia, chest discomfort, tooth abscess, osteoarthritis, acne and contact dermatitis. Eleven AEs occurred at a higher incidence in the non-exposed group for which the 95 percent confidence intervals around the between-group difference excluded zero and were as follows: bradycardia, goiter, change in bowel habit, blood glucose decreased, blood glucose increased, weight increased, hypoglycemia, sinus headache, prostatitis, balanitis and hyperkeratosis.

Investigational use of combination therapy with JANUVIA, metformin, and rosiglitazone: study design and results

In this study, 262 patients (mean baseline A1C 8.8 percent) taking metformin (greater than or equal to 1500 mg/day) and rosiglitazone (greater than or equal to 4 mg/day) were randomized in a 2:1 ratio to the addition of JANUVIA (n=170) or placebo (n=92). After 18 weeks, the addition of JANUVIA significantly (p

In the continuation of this study out to 54-weeks, the addition of JANUVIA to the combination of metformin and rosiglitazone was generally well tolerated and continued to show significant (p

Treatment with an investigational dosing regimen of JANUVIA (50 mg once daily) added to ongoing pioglitazone therapy in Japanese patients with type 2 diabetes over 52 weeks: study design and results

A 12-week double-blind period where patients (n=134) on a stable dose of pioglitazone were randomized to the addition of JANUVIA 50 mg (n=66) or placebo (n=68) was followed by a 40-week open-label extension period where patients on placebo were reallocated to JANUVIA 50 mg and JANUVIA could be titrated from 50 mg to 100 mg. In the double-blind period, JANUVIA significantly reduced mean A1C from baseline relative to placebo at week 12 by 0.8 percent. In the open-label extension period of 66 patients allocated to JANUVIA treatment, 50 patients completed 52-weeks of treatment. In this patient population, efficacy at week 52 was observed with a sustained change in A1C from baseline of 0.7 percent and with 62 percent of patients at an A1C goal of less than seven percent. Treatment with JANUVIA was generally well tolerated compared to placebo with a low occurrence of hypoglycemia (3.0 percent vs. 2.9 percent) and edema (1.5 percent vs. 0.0 percent) and without clinically meaningful change in body weight.

Dosing of JANUVIA

The recommended dose of JANUVIA is 100 mg once daily, with or without food, for all approved indications. No dosage adjustment is needed for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl ?50 mL/min). To achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency as well as in end-stage renal disease (ESRD) patients requiring hemodialysis. For patients with moderate renal insufficiency (CrCl ?30 to

Selected cautionary information for JANUVIA

Because JANUVIA is renally eliminated, and to achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, a dosage adjustment is recommended in patients with moderate renal insufficiency and in patients with severe renal insufficiency or with ESRD requiring hemodialysis or peritoneal dialysis. Safety and effectiveness of JANUVIA in pediatric patients have not been established. There are no adequate and well-controlled studies in pregnant women. JANUVIA should be used during pregnancy only if clearly needed. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when JANUVIA is administered to a nursing woman. There have been post-marketing reports of hypersensitivity reactions in patients treated with JANUVIA. These reactions include anaphylaxis, angiedema and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first three months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event and institute alternative treatment for diabetes.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or any other anti-diabetic drug.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programmes that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company’s periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

JANUVIA? is a trademark of Merck & Co., Inc.

Prescribing information and patient product information for JANUVIA are attached.

1 A1C is a measure of a person’s average blood glucose over a two- to three-month period.

Patient Information

JANUVIA? (jah-NEW-vee-ah)

(sitagliptin)

Tablets

Read the Patient Information that comes with JANUVIA* before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is JANUVIA?

JANUVIA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JANUVIA lowers blood sugar when blood sugar is high, especially after a meal. JANUVIA also lowers blood sugar between meals. JANUVIA helps to improve the levels of insulin produced by your own body after a meal. JANUVIA decreases the amount of sugar made by the body. JANUVIA is unlikely to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work when your blood sugar is low. JANUVIA has not been studied in children under 18 years of age.

JANUVIA has not been studied with insulin, a medicine known to cause low blood sugar.

Who should not take JANUVIA?

Do not take JANUVIA if you:

have had an allergic reaction to JANUVIA. JANUVIA should not be used to treat patients with:

Type 1 diabetes. Diabetic ketoacidosis (increased ketones in the blood or urine). What should I tell my doctor before and during treatment with JANUVIA?

Tell your doctor about all of your medical conditions, including if you:

have had an allergic reaction to JANUVIA. have kidney problems. are pregnant or plan to become pregnant. It is not known if JANUVIA will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. If you use JANUVIA during pregnancy, talk with your doctor about how you can be on the JANUVIA registry. The toll-free telephone number for the pregnancy registry is: 1-800-986-8999. are breast-feeding or plan to breast-feed. It is not known if JANUVIA will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUVIA. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take JANUVIA?

Take JANUVIA exactly as your doctor tells you to take it. Take JANUVIA by mouth once a day. Take JANUVIA with or without food. If you have kidney problems, your doctor may prescribe lower doses of JANUVIA. Your doctor may perform blood tests on you from time to time to measure how well your kidneys are working. Your doctor may prescribe JANUVIA along with certain other medicines that lower blood sugar. If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of JANUVIA at the same time. If you take too much JANUVIA, call your doctor or local Poison Control Center right away. When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions. Monitor your blood sugar as your doctor tells you to. Stay on your prescribed diet and exercise program while taking JANUVIA. Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes. Your doctor will monitor your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C. What are the possible side effects of JANUVIA?

The most common side effects of JANUVIA include:

Upper respiratory infection Stuffy or runny nose and sore throat Headache JANUVIA may occasionally cause stomach discomfort and diarrhea.

When JANUVIA is used in combination with another type of diabetes medicine known as a sulfonylurea, low blood sugar (hypoglycemia) due to the sulfonylurea can occur. Your doctor may prescribe lower doses of the sulfonylurea medicine.

The following additional side effects have been reported in general use with JANUVIA:

Allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking JANUVIA and call your doctor right away. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes. Tell your doctor if you have any side effect that bothers you or that does not go away.

Other side effects may occur when using JANUVIA. For more information, ask your doctor.

How should I store JANUVIA?

Store JANUVIA at room temperature, 68 to 77?F (20 to 25?C). Keep JANUVIA and all medicines out of the reach of children.

General information about the use of JANUVIA

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use JANUVIA for a condition for which it was not prescribed. Do not give JANUVIA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about JANUVIA. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for additional information about JANUVIA that is written for health professionals. For more information call 1-800-622-4477.

What are the ingredients in JANUVIA?

Active ingredient: sitagliptin

Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness, and amputation.

High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.

Revised July 2008 ? Manufactured for: ? K MERCK & CO., INC., Whitehouse Station, NJ 08889, USA ? Manufactured by: ? Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21 27100 – Pavia, Italy ? 9762705 ? * Trademark of MERCK & CO., Inc., Whitehouse Station, New Jersey, 08889 USA COPYRIGHT (C) 2006, 2007 MERCK & CO., Inc. All rights reserved 9762705

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA.

? JANUVIA(TM) (sitagliptin) Tablets

Initial U.S. Approval: 2006

? RECENT MAJOR CHANGES

Indications and Usage ? Monotherapy and Combination Therapy (1.1) 10/2007 Important Limitations of Use (1.2) 10/2007 Dosage and Administration Recommended Dosing (2.1) 10/2007 Concomitant Use with a Sulfonylurea (2.3) 10/2007 Contraindications (4) 10/2007 Warnings and Precautions Use with Medications Known to Cause Hypoglycemia (5.2) 10/2007 Hypersensitivity Reactions (5.3) 10/2007 Macrovascular Outcomes (5.4) 07/2008 INDICATIONS AND USAGE

JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1.1)

Important Limitations of Use:

JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1.2) JANUVIA has not been studied in combination with insulin. (1.2) DOSAGE AND ADMINISTRATION

The recommended dose of JANUVIA is 100?mg once daily. JANUVIA can be taken with or without food. (2.1)

Dosage adjustment is recommended for patients with moderate or severe renal insufficiency or end-stage renal disease. (2.2)

? Dosage Adjustment in Patients With Moderate, Severe and End Stage Renal Disease (ESRD) (2.2) 50 mg once daily ? 25 mg once daily Moderate

CrCl ?30 to

~Serum Cr levels [mg/dL]

Men: >1.7? ?3.0;

Women: >1.5? ?2.5

? Severe and ESRD

CrCl

Men: >3.0;

Women: >2.5;

or on dialysis

DOSAGE FORMS AND STRENGTHS

Tablets: 100?mg, 50?mg, and 25?mg (3)

CONTRAINDICATIONS

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema (5.3, 6.2)

WARNINGS AND PRECAUTIONS

Dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. (2.2, 5.1) When used with a sulfonylurea, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. (2.3, 5.2) There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop JANUVIA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. (5.3, 6.2) There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or any other anti-diabetic drug. (5.4) ADVERSE REACTIONS

Adverse reactions reported in (?)5% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. Hypoglycemia was also reported more commonly in patients treated with the combination of JANUVIA and sulfonylurea, with or without metformin, than in patients given the combination of placebo and sulfonylurea, with or without metformin. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Safety and effectiveness of JANUVIA in children under 18 years have not been established. (8.4) There are no adequate and well-controlled studies in pregnant women. To report drug exposure during pregnancy call 1-800-986-8999. (8.1) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 07/2008

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Monotherapy and Combination Therapy 1.2 Important Limitations of Use 2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing 2.2 Patients with Renal Insufficiency 2.3 Concomitant Use with a Sulfonylurea 3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Use in Patients with Renal Insufficiency 5.2 Use with Medications Known to Cause Hypoglycemia 5.3 Hypersensitivity Reactions 5.4 Macrovascular Outcomes 6 ADVERSE REACTIONS

6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS

7.1 Digoxin 8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES

14.1 Monotherapy 14.2 Combination Therapy 16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Instructions 17.2 Laboratory Tests *Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Monotherapy and Combination Therapy

JANUVIA1 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies (14).]

1.2 Important Limitations of Use

JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

JANUVIA has not been studied in combination with insulin.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

The recommended dose of JANUVIA is 100?mg once daily. JANUVIA can be taken with or without food.

2.2 Patients with Renal Insufficiency

For patients with mild renal insufficiency (creatinine clearance [CrCl] ?50?mL/min, approximately corresponding to serum creatinine levels of ?1.7?mg/dL in men and ?1.5?mg/dL in women), no dosage adjustment for JANUVIA is required.

For patients with moderate renal insufficiency (CrCl ?30 to 1.7 to ?3.0?mg/dL in men and >1.5 to ?2.5?mg/dL in women), the dose of JANUVIA is 50?mg once daily.

For patients with severe renal insufficiency (CrCl 3.0?mg/dL in men and >2.5?mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25?mg once daily. JANUVIA may be administered without regard to the timing of hemodialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See Clinical Pharmacology (12.3).]

2.3 Concomitant Use with a Sulfonylurea

When JANUVIA is used in combination with a sulfonylurea, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.2).]

3 DOSAGE FORMS AND STRENGTHS

— 100?mg tablets are beige, round, film-coated tablets with “277″ on one side.

— 50?mg tablets are light beige, round, film-coated tablets with “112″ on one side.

— 25?mg tablets are pink, round, film-coated tablets with “221″ on one side.

4 CONTRAINDICATIONS

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.3) and Adverse Reactions (6.2).]

5 WARNINGS AND PRECAUTIONS

5.1 Use in Patients with Renal Insufficiency

A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. [See Dosage and Administration (2.2); Clinical Pharmacology (12.3).]

5.2 Use with Medications Known to Cause Hypoglycemia

As is typical with other antihyperglycemic agents used in combination with a sulfonylurea, when JANUVIA was used in combination with a sulfonylurea, a class of medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. [See Adverse Reactions (6.1).] Therefore, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. [See Dosage and Administration (2.3).]

5.3 Hypersensitivity Reactions

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes. [See Adverse Reactions (6.2).]

5.4 Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or any other anti-diabetic drug.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical studies as both monotherapy and combination therapy with metformin or pioglitazone, the overall incidence of adverse reactions, hypoglycemia, and discontinuation of therapy due to clinical adverse reactions with JANUVIA were similar to placebo. In combination with glimepiride, with or without metformin, the overall incidence of clinical adverse reactions with JANUVIA was higher than with placebo, in part related to a higher incidence of hypoglycemia (see Table?1); the incidence of discontinuation due to clinical adverse reactions was similar to placebo.

Two placebo-controlled monotherapy studies, one of 18- and one of 24-week duration, included patients treated with JANUVIA 100?mg daily, JANUVIA 200?mg daily, and placebo. Three 24-week, placebo-controlled add-on combination therapy studies, one with metformin, one with pioglitazone, and one with glimepiride with or without metformin, were also conducted. In addition to a stable dose of metformin, pioglitazone, glimepiride, or glimepiride and metformin, patients whose diabetes was not adequately controlled were given either JANUVIA 100?mg daily or placebo. The adverse reactions, reported regardless of investigator assessment of causality in ?5% of patients treated with JANUVIA 100?mg daily as monotherapy, JANUVIA in combination with pioglitazone, or JANUVIA in combination with glimepiride, with or without metformin, and more commonly than in patients treated with placebo, are shown in Table?1.

Table 1

Placebo-Controlled Clinical Studies of JANUVIA Monotherapy or Add-on Combination Therapy with Pioglitazone or Glimepiride +/- Metformin:

Adverse Reactions Reported in ?5% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of Causality?

? ? Number of Patients (%) Monotherapy ? JANUVIA 100 mg ? Placebo ? ? N = 443 ? N = 363 Nasopharyngitis ? 23 (5.2) ? 12 (3.3) Combination with Pioglitazone ? JANUVIA 100 mg + Pioglitazone

? Placebo + Pioglitazone

? ? N = 175 ? N = 178 Upper Respiratory Tract Infection ? 11 (6.3) ? 6 (3.4) Headache ? 9 (5.1) ? 7 (3.9) Combination with Glimepiride (+/- Metformin) ? JANUVIA 100 mg + Glimepiride

(+/- Metformin)

? Placebo + Glimepiride

(+/- Metformin)

? ? N = 222 ? N = 219 Hypoglycemia ? 27 (12.2) ? 4 (1.8) Nasopharyngitis ? 14 (6.3) ? 10 (4.6) Headache ? 13 (5.9) ? 5 (2.3) ? Intent to treat population

In the study of patients receiving JANUVIA as add-on combination therapy with metformin, there were no adverse reactions reported regardless of investigator assessment of causality in ?5% of patients and more commonly than in patients given placebo.

In the prespecified pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia in patients treated with JANUVIA 100?mg was similar to placebo (1.2% vs 0.9%). Adverse reactions of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (JANUVIA 100?mg, 2.3%; placebo, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%).

In an additional, 24-week, placebo-controlled factorial study of initial therapy with sitagliptin in combination with metformin, the adverse reactions reported (regardless of investigator assessment of causality) in ?5% of patients are shown in Table 2. The incidence of hypoglycemia was 0.6% in patients given placebo, 0.6% in patients given sitagliptin alone, 0.8% in patients given metformin alone, and 1.6% in patients given sitagliptin in combination with metformin.

Table 2

Initial Therapy with Combination of Sitagliptin and Metformin:

Adverse Reactions Reported (Regardless of Investigator Assessment of Causality) in ?5% of Patients Receiving Combination Therapy (and Greater than in Patients Receiving Metformin alone, Sitagliptin alone, and Placebo)?

? ? Number of Patients (%) ? ? Placebo

? Sitagliptin (JANUVIA)

100 mg QD

? Metformin

500 or 1000 mg bid ??

? Sitagliptin

50 mg bid +

Metformin

500 or 1000 mg bid ??

? ? N = 176 ? N = 179 ? N = 364??

? N = 372??

Upper Respiratory Infection ? 9 (5.1) ? 8 (4.5) ? 19 (5.2) ? 23 (6.2) Headache ? 5 (2.8) ? 2 (1.1) ? 14 (3.8) ? 22 (5.9) ? Intent-to-treat population.

?? Data pooled for the patients given the lower and higher doses of metformin.

No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed in patients treated with JANUVIA.

Laboratory Tests

Across clinical studies, the incidence of laboratory adverse reactions was similar in patients treated with JANUVIA 100?mg compared to patients treated with placebo. A small increase in white blood cell count (WBC) was observed due to an increase in neutrophils. This increase in WBC (of approximately 200 cells/microL vs placebo, in four pooled placebo-controlled clinical studies, with a mean baseline WBC count of approximately 6600 cells/microL) is not considered to be clinically relevant. In a 12-week study of 91 patients with chronic renal insufficiency, 37 patients with moderate renal insufficiency were randomized to JANUVIA 50?mg daily, while 14 patients with the same magnitude of renal impairment were randomized to placebo. Mean (SE) increases in serum creatinine were observed in patients treated with JANUVIA [0.12?mg/dL (0.04)] and in patients treated with placebo [0.07?mg/dL (0.07)]. The clinical significance of this added increase in serum creatinine relative to placebo is not known.

6.2 Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of JANUVIA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions include anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome. [See Warnings and Precautions (5.3).]

7 DRUG INTERACTIONS

7.1 Digoxin

There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100?mg sitagliptin for 10 days. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or JANUVIA is recommended.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category?B:

Reproduction studies have been performed in rats and rabbits. Doses of sitagliptin up to 125?mg/kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Merck & Co., Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to JANUVIA while pregnant. Health care providers are encouraged to report any prenatal exposure to JANUVIA by calling the Pregnancy Registry at (800) 986-8999.

Sitagliptin administered to pregnant female rats and rabbits from gestation day 6 to 20 (organogenesis) was not teratogenic at oral doses up to 250?mg/kg (rats) and 125?mg/kg (rabbits), or approximately 30- and 20-times human exposure at the maximum recommended human dose (MRHD) of 100?mg/day based on AUC comparisons. Higher doses increased the incidence of rib malformations in offspring at 1000?mg/kg, or approximately 100 times human exposure at the MRHD.

Sitagliptin administered to female rats from gestation day 6 to lactation day 21 decreased body weight in male and female offspring at 1000?mg/kg. No functional or behavioral toxicity was observed in offspring of rats.

Placental transfer of sitagliptin administered to pregnant rats was approximately 45% at 2 hours and 80% at 24 hours postdose. Placental transfer of sitagliptin administered to pregnant rabbits was approximately 66% at 2 hours and 30% at 24 hours.

8.3 Nursing Mothers

Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when JANUVIA is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of JANUVIA in pediatric patients under 18 years of age have not been established.

8.5 Geriatric Use

Of the total number of subjects (N=3884) in pre-approval clinical safety and efficacy studies of JANUVIA, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter [see Dosage and Administration (2.2); Clinical Pharmacology (12.3)].

10 OVERDOSAGE

During controlled clinical trials in healthy subjects, single doses of up to 800?mg JANUVIA were administered. Maximal mean increases in QTc of 8.0?msec were observed in one study at a dose of 800?mg JANUVIA, a mean effect that is not considered clinically important [see Clinical Pharmacology (12.2)]. There is no experience with doses above 800?mg in humans. In Phase?I multiple-dose studies, there were no dose-related clinical adverse reactions observed with JANUVIA with doses of up to 600 mg per day for periods of up to 10 days and 400?mg per day for up to 28 days.

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient’s clinical status.

Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.

11 DESCRIPTION

JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl] -5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.

The empirical formula is C16H15F6N5O?H3PO4?H2O and the molecular weight is 523.32. The structural formula is:

(Graphic Omitted)

Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.

Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5?mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100?mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by JANUVIA, thereby increasing and prolonging the action of these hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By increasing and prolonging active incretin levels, JANUVIA increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner. Sitagliptin demonstrates selectivity for DPP-4 and does not inhibit DPP-8 or DPP-9 activity in vitro at concentrations approximating those from therapeutic doses.

12.2 Pharmacodynamics

General

In patients with type 2 diabetes, administration of JANUVIA led to inhibition of DPP-4 enzyme activity for a 24-hour period. After an oral glucose load or a meal, this DPP-4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active GLP-1 and GIP, decreased glucagon concentrations, and increased responsiveness of insulin release to glucose, resulting in higher C-peptide and insulin concentrations. The rise in insulin with the decrease in glucagon was associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.

In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents. Co-administration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations. Sitagliptin, but not metformin, increased active GIP concentrations. It is unclear how these findings relate to changes in glycemic control in patients with type 2 diabetes.

In studies with healthy subjects, JANUVIA did not lower blood glucose or cause hypoglycemia.

Cardiac Electrophysiology

In a randomized, placebo-controlled crossover study, 79 healthy subjects were administered a single oral dose of JANUVIA 100?mg, JANUVIA 800?mg (8 times the recommended dose), and placebo. At the recommended dose of 100?mg, there was no effect on the QTc interval obtained at the peak plasma concentration, or at any other time during the study. Following the 800?mg dose, the maximum increase in the placebo-corrected mean change in QTc from baseline was observed at 3 hours postdose and was 8.0?msec. This increase is not considered to be clinically significant. At the 800?mg dose, peak sitagliptin plasma concentrations were approximately 11 times higher than the peak concentrations following a 100?mg dose.

In patients with type 2 diabetes administered JANUVIA 100?mg (N=81) or JANUVIA 200?mg (N=63) daily, there were no meaningful changes in QTc interval based on ECG data obtained at the time of expected peak plasma concentration.

12.3 Pharmacokinetics

The pharmacokinetics of sitagliptin has been extensively characterized in healthy subjects and patients with type 2 diabetes. After oral administration of a 100?mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours postdose. Plasma AUC of sitagliptin increased in a dose-proportional manner. Following a single oral 100?mg dose to healthy volunteers, mean plasma AUC of sitagliptin was 8.52 ?M?hr, Cmax was 950?nM, and apparent terminal half-life (t1/2) was 12.4 hours. Plasma AUC of sitagliptin increased approximately 14% following 100?mg doses at steady-state compared to the first dose. The intra-subject and inter-subject coefficients of variation for sitagliptin AUC were small (5.8% and 15.1%). The pharmacokinetics of sitagliptin was generally similar in healthy subjects and in patients with type 2 diabetes.

Absorption

The absolute bioavailability of sitagliptin is approximately 87%. Because coadministration of a high-fat meal with JANUVIA had no effect on the pharmacokinetics, JANUVIA may be administered with or without food.

Distribution

The mean volume of distribution at steady state following a single 100?mg intravenous dose of sitagliptin to healthy subjects is approximately 198 liters. The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).

Metabolism

Approximately 79% of sitagliptin is excreted unchanged in the urine with metabolism being a minor pathway of elimination.

Following a [14C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin. Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin. In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8.

Excretion

Following administration of an oral [14C]sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in feces (13%) or urine (87%) within one week of dosing. The apparent terminal t1/2 following a 100?mg oral dose of sitagliptin was approximately 12.4 hours and renal clearance was approximately 350?mL/min.

Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion. Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin. The clinical relevance of hOAT-3 in sitagliptin transport has not been established. Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin. However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.

Special Populations

Renal Insufficiency

A single-dose, open-label study was conducted to evaluate the pharmacokinetics of JANUVIA (50?mg dose) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects. The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to

CrCl =

? [140 - age (years)] x weight (kg)

[72 x serum creatinine (mg/dL)]

Compared to normal healthy control subjects, an approximate 1.1- to 1.6-fold increase in plasma AUC of sitagliptin was observed in patients with mild renal insufficiency. Because increases of this magnitude are not clinically relevant, dosage adjustment in patients with mild renal insufficiency is not necessary. Plasma AUC levels of sitagliptin were increased approximately 2-fold and 4-fold in patients with moderate renal insufficiency and in patients with severe renal insufficiency, including patients with ESRD on hemodialysis, respectively. Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose). To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal insufficiency, as well as in ESRD patients requiring hemodialysis. [See Dosage and Administration (2.2).]

Hepatic Insufficiency

In patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), mean AUC and Cmax of sitagliptin increased approximately 21% and 13%, respectively, compared to healthy matched controls following administration of a single 100?mg dose of JANUVIA. These differences are not considered to be clinically meaningful. No dosage adjustment for JANUVIA is necessary for patients with mild or moderate hepatic insufficiency.

There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score >9).

Body Mass Index (BMI)

No dosage adjustment is necessary based on BMI. Body mass index had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.

Gender

No dosage adjustment is necessary based on gender. Gender had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.

Geriatric

No dosage adjustment is required based solely on age. When the effects of age on renal function are taken into account, age alone did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis. Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.

Pediatric

Studies characterizing the pharmacokinetics of sitagliptin in pediatric patients have not been performed.

Race

No dosage adjustment is necessary based on race. Race had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of available pharmacokinetic data, including subjects of white, Hispanic, black, Asian, and other racial groups.

Drug Interactions

In Vitro Assessment of Drug Interactions

Sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4. Sitagliptin is a p-glycoprotein substrate, but does not inhibit p-glycoprotein mediated transport of digoxin. Based on these results, sitagliptin is considered unlikely to cause interactions with other drugs that utilize these pathways.

Sitagliptin is not extensively bound to plasma proteins. Therefore, the propensity of sitagliptin to be involved in clinically meaningful drug-drug interactions mediated by plasma protein binding displacement is very low.

In Vivo Assessment of Drug Interactions

Effects of Sitagliptin on Other Drugs

In clinical studies, as described below, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing drug interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).

Digoxin: Sitagliptin had a minimal effect on the pharmacokinetics of digoxin. Following administration of 0.25?mg digoxin concomitantly with 100?mg of JANUVIA daily for 10 days, the plasma AUC of digoxin was increased by 11%, and the plasma Cmax by 18%.

Metformin: Co-administration of multiple twice-daily doses of sitagliptin with metformin, an OCT substrate, did not meaningfully alter the pharmacokinetics of metformin in patients with type 2 diabetes. Therefore, sitagliptin is not an inhibitor of OCT-mediated transport.

Sulfonylureas: Single-dose pharmacokinetics of glyburide, a CYP2C9 substrate, was not meaningfully altered in subjects receiving multiple doses of sitagliptin. Clinically meaningful interactions would not be expected with other sulfonylureas (e.g., glipizide, tolbutamide, and glimepiride) which, like glyburide, are primarily eliminated by CYP2C9.

Simvastatin: Single-dose pharmacokinetics of simvastatin, a CYP3A4 substrate, was not meaningfully altered in subjects receiving multiple daily doses of sitagliptin. Therefore, sitagliptin is not an inhibitor of CYP3A4-mediated metabolism.

Thiazolidinediones: Single-dose pharmacokinetics of rosiglitazone was not meaningfully altered in subjects receiving multiple daily doses of sitagliptin, indicating that JANUVIA is not an inhibitor of CYP2C8-mediated metabolism.

Warfarin: Multiple daily doses of sitagliptin did not meaningfully alter the pharmacokinetics, as assessed by measurement of S(-) or R(+) warfarin enantiomers, or pharmacodynamics (as assessed by measurement of prothrombin INR) of a single dose of warfarin. Because S(-) warfarin is primarily metabolized by CYP2C9, these data also support the conclusion that sitagliptin is not a CYP2C9 inhibitor.

Oral Contraceptives: Co-administration with sitagliptin did not meaningfully alter the steady-state pharmacokinetics of norethindrone or ethinyl estradiol.

Effects of Other Drugs on Sitagliptin

Clinical data described below suggest that sitagliptin is not susceptible to clinically meaningful interactions by co-administered medications.

Metformin: Co-administration of multiple twice-daily doses of metformin with sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.

Cyclosporine: A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin. Co-administration of a single 100?mg oral dose of JANUVIA and a single 600?mg oral dose of cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29% and 68%, respectively. These modest changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful. The renal clearance of sitagliptin was also not meaningfully altered. Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment?of?Fertility

A two-year carcinogenicity study was conducted in male and female rats given oral doses of sitagliptin of 50, 150, and 500?mg/kg/day. There was an increased incidence of combined liver adenoma/carcinoma in males and females and of liver carcinoma in females at 500?mg/kg. This dose results in exposures approximately 60 times the human exposure at the maximum recommended daily adult human dose (MRHD) of 100?mg/day based on AUC comparisons. Liver tumors were not observed at 150?mg/kg, approximately 20 times the human exposure at the MRHD. A two-year carcinogenicity study was conducted in male and female mice given oral doses of sitagliptin of 50, 125, 250, and 500?mg/kg/day. There was no increase in the incidence of tumors in any organ up to 500?mg/kg, approximately 70 times human exposure at the MRHD. Sitagliptin was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a Chinese hamster ovary (CHO) chromosome aberration assay, an in vitro cytogenetics assay in CHO, an in vitro rat hepatocyte DNA alkaline elution assay, and an in vivo micronucleus assay.

In rat fertility studies with oral gavage doses of 125, 250, and 1000?mg/kg, males were treated for 4 weeks prior to mating, during mating, up to scheduled termination (approximately 8 weeks total) and females were treated 2 weeks prior to mating through gestation day 7. No adverse effect on fertility was observed at 125?mg/kg (approximately 12 times human exposure at the MRHD of 100?mg/day based on AUC comparisons). At higher doses, nondose-related increased resorptions in females were observed (approximately 25 and 100 times human exposure at the MRHD based on AUC comparison).

14 CLINICAL STUDIES

There were approximately 3800 patients with type 2 diabetes randomized in six double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of sitagliptin on glycemic control. The ethnic/racial distribution in these studies was approximately 60% white, 20% Hispanic, 8% Asian, 6% black, and 6% other groups. Patients had an overall mean age of approximately 55 years (range 18 to 87 years). In addition, an active (glipizide)-controlled study of 52-weeks duration was conducted in 1172 patients with type 2 diabetes who had inadequate glycemic control on metformin.

In patients with type 2 diabetes, treatment with JANUVIA produced clinically significant improvements in hemoglobin A1C, fasting plasma glucose (FPG) and 2-hour post-prandial glucose (PPG) compared to placebo.

14.1 Monotherapy

A total of 1262 patients with type 2 diabetes participated in two double-blind, placebo-controlled studies, one of 18-week and another of 24-week duration, to evaluate the efficacy and safety of JANUVIA monotherapy. In both monotherapy studies, patients currently on an antihyperglycemic agent discontinued the agent, and underwent a diet, exercise, and drug washout period of about 7 weeks. Patients with inadequate glycemic control (A1C 7% to 10%) after the washout period were randomized after completing a 2-week single-blind placebo run-in period; patients not currently on antihyperglycemic agents (off therapy for at least 8 weeks) with inadequate glycemic control (A1C 7% to 10%) were randomized after completing the 2-week single-blind placebo run-in period. In the 18-week study, 521 patients were randomized to placebo, JANUVIA 100?mg, or JANUVIA 200?mg, and in the 24-week study 741 patients were randomized to placebo, JANUVIA 100?mg, or JANUVIA 200?mg. Patients who failed to meet specific glycemic goals during the studies were treated with metformin rescue, added on to placebo or JANUVIA.

Treatment with JANUVIA at 100&#1

Related Carcinoma Press Releases

New State-of-the-Art Institute for Digestive Health and Liver Disease Opens at Mercy Medical Center

August 09, 2012 No comments

Baltimore, MD (Vocus) September 15, 2008

Mercy Medical Center will open the doors of its new, multi-million dollar, one-of-a-kind treatment center for the diagnosis and treatment of digestive diseases on Monday, Sept. 15, 2008. The Institute for Digestive Health and Liver Disease at Mercy comprises the entire 7th floor of Mercy’s Professional Office Building.

The Institute will address inflammatory bowel disease, hepatology, gastroenterology, endoscopy, colon-rectal disorders, and provide Remicade infusion services, Thomas R. Mullen, President and CEO of Mercy Health Services, Mercy Medical Center, has announced.

Joining Mercy are renowned physicians Drs. Paul Thuluvath, Mary Harris, and Sergey Kantsevoy – all formerly of Johns Hopkins. They join the noted Mercy team of gastroenterologists, Drs. David Posner, Michael Cox, Scott Huber and Patrick Hyatt, and colon-rectal surgeon, Dr. Debra Vachon.

In addition, gastroenterologists Drs. Richard Desi and Laura Pichney will also be members of the new team, bringing expertise in community colorectal screening.

“By combining the medical expertise of these physicians with progressive technology -

including state-of-the-art endoscopic equipment, as well as Mercy’s 134-tradition of providing compassionate and quality care – the new Institute for Digestive Health and Liver Disease at Mercy is positioned to be the leading center in the region for digestive health,” Mr. Mullen said.

According to Mercy Chief of Gastroenterology Dr. David Posner, Director of the new Institute, patients will have access to endoscopic procedures such as interventional endoscopy, endoscopic ultrasound and capsule endoscopy for the diagnosis of “a number of digestive and related disorders. The Institute provides expert treatment for bilary tract disease including bile duct cancer; gallstone disease, inflammatory conditions of the colon, Crohn’s Disease, ulcerative colitis, inflammatory bowel and irritable bowel disease, colorectal cancer, esophageal disorders, reflux, swallowing disorders, heartburn, liver disease including hepatitis, and as well as disorders of the pancreas, stomach and duodenum,” Dr. Posner said.

The new Institute will also take part in clinical trials for Hepatitis B, C, and liver cancer, as well as genetic counseling and preventive medical services, in coordination with Mercy’s Prevention and Research center under nationally renowned cancer researcher and epidemiologist Dr. Kathy J. Helzlsouer.

Other features to the Institute will include a women’s center for diarrheal management, treating inflammatory bowel disease in pregnancy, minimally invasive endoscopic surgery, a comprehensive liver center, including liver transplantation services, and a Remicade infusion center.

Remicade (Infliximba) is a drug used to treat autoimmune disorders and has been approved by the USFDA for the treatment of Crohn’s Disease and ulcerative colitis. Remicade is delivered by intravenous infusion or IV, typically at 6-8 week intervals.

“Many of the physicians who comprise the staff of the new Institute have national and international reputations for their work, such as in the treatment of inflammatory bowel disease, chronic liver disease, pancreatic cancer, and more. Mercy already has a reputation as one of the nation’s finest hospitals in terms of quality of care. This new Institute is further evidence of our dedication to providing patients with advanced therapies so that they may enjoy a better, healthier, quality of life,” Mr. Mullen said.

Below are brief biographies of the new Institute’s physician staff:

David B. Posner, M.D.

David B. Posner, M.D., Chief of Gastroenterology at Mercy, is a graduate of the University of Maryland School of Medicine. Dr. Posner is certified by the American Board of Internal Medicine with a subspecialty in Gastroenterology. He is a fellow of the American College of Physicians, American Gastroenterological Society, and American College of Gastroenterology as well as American Society for Gastrointestinal Endoscopy, American Association for the Study of Liver Diseases, and Baltimore City Medical Society. Dr. Posner is past president of the Maryland Society of Gastrointestinal Endoscopy.

For the past 20 years, Dr. Posner has taught students and residents from the University of Maryland. As Attending Physician at Mercy Medical Center, Dr. Posner teaches residents in medicine and surgery and received the Outstanding Physician-Teacher Award in 1982. He has authored numerous abstracts and publications.

Paul J. Thuluvath, M.D.

Paul J. Thuluvath, M.D., received his medical degree from the University of Sheffield School of Medicine, England. He completed an internship and residency in Internal Medicine at St. Johns Medical College Hospital, India, as well as a residency in Internal Medicine at the Dunston Hill Hospital and Castle Hill Hospital, England. He completed his Gastroenterology and Hepatology fellowship at the University of Cambridge, England. Board Certified in Gastroenterology and Internal Medicine, Dr. Thuluvath specializes in liver disease, liver transplantation, ERCP, liver cancer, and primary sclerosing cholangitis. He has extensive research experience, has authored numerous articles, book chapters, and editorials, and is an international speaker. A fellow of the American College of Gastroenterology and Royal College of Physicians of London, Dr. Thuluvath is a member of the American Association for Study of Liver Disease, American Gastrenterological Association, American Society for Gastrointestinal Endoscopy, International Liver Transplant Society, The Transplantation Society, and European Association for Study of Liver Diseases.

Mary L. Harris, M.D.

Mary L. Harris, M.D., received her medical degree from the University of Virginia School of Medicine, where she also completed her internship and residency in Internal Medicine. She completed her Gastroenterology fellowship at The Johns Hopkins Hospital. Her interests include Crohn’s Disease, ulcerative colitis, pregnancy and IBD, general endoscopy, and diarrhea. Dr. Harris is a member of the American Gastroenterologist Association and American College of Physicians. She also serves on the Board of Directors of the Maryland Crohn’s & Colitis Foundation of America Physician Advisory Committee. Dr. Harris has participated in many research programs and is the author of many manuscripts, book chapters, and abstracts.

Sergey Kantsevoy, M.D., Ph.D.

Sergey Kantsevoy, M.D., Ph.D., received his medical degree from Gorky Medical Institute, Gorky, Russia, where he also completed a residency in Surgery. His surgical internship was completed at Bronx-Lebanon Hospital Center, Bronx, NY. He completed an Internal Medicine internship and residency at Washington Hospital Center, Washington, D.C. Dr. Kantsevoy completed his fellowship in Gastroenterology and Hepatology at The Johns Hopkins University School of Medicine. Board Certified in Gastroenterology and Hepatology as well as Internal Medicine, Dr. Kantsevoy specializes in interventional endoscopy and endoscopic ultrasound. He is a member of the American Gastroenterological Association and American Society for Gastrointestinal Endoscopy. Dr. Kantsevoy is an international lecturer and course director, author of various abstracts, book chapters, and articles, and has been issued various patents.

Michael E. Cox, M.D.

Michael E. Cox, M.D., Assistant Chief of Gastroenterology, is a graduate of the University of Maryland Medical School with certifications in both Gastroenterology and Internal Medicine. His research interests include endoscopic laser surgery and Hepatitis C. He has been a clinical assistant professor of medicine at the University of Maryland since 1981 and was the first medical director of the Maryland Endoscopy Center. Dr. Cox is a member of the American Gastroenterology Association and American Society of Gastrointestinal Endoscopy, as well as Maryland Society of Gastrointestinal Endoscopy, for which he served as president from 1997 through 1999. His fellowships include the American College of Gastroenterology (FACG) and American College of Physicians (FACP). He has authored numerous papers and publications.

Debra A. Vachon, M.D.

Debra A. Vachon, M.D., received her medical degree from the University of Maryland School of Medicine. Board Certified in both general surgery and colon-rectal surgery, Dr. Vachon is a fellow of the American College of Surgeons and American Society of Colon and Rectal Surgeons. She has made numerous presentations regarding the Delorme procedure for complete rectal prolapse in severely debilitated patients; management of inflammatory carcinoma of the breast; and surgical complications in children with HIV infections

Scott Huber, M.D.

Scott Huber, M.D., earned his medical degree from the University of Pittsburgh School of Medicine. He completed his residency in Internal Medicine through the University of Maryland Medical System and fellowship in Gastroenterology at Brown University and Rhode Island Hospital. Board Certified in Internal Medicine and specialist in Gastroenterology, Dr. Huber has conducted research in the gastroenterology field at Brown University and Johns Hopkins University.

Patrick Hyatt, M.D.

Patrick Hyatt, M.D., earned his medical degree at the Temple University School of Medicine in Philadelphia. He completed his residency in Internal Medicine and his fellowship in Gastroenterology at Brown University in Providence, Rhode Island. Dr. Hyatt is certified by the American Board of Internal Medicine and is Board-Eligible in Gastroenterology. He has numerous clinical presentations and medical publications to his credit, addressing disorders of the GI tract as well as treatments such as chemoprevention of colon cancer. Dr. Hyatt is a member of the American Gastroenterological Association, American Society of Gastrointestinal Endoscopy, and American College of Gastroenterology.

Lisa Pichney, M.D.

Lisa Pichney, M.D., received her medical degree from the University of Maryland School of Medicine. She completed her internship and residency in Internal Medicine and her fellowship in Gastroenterology at the University of Maryland Hospital/Baltimore V.A. Medical Center. Board Certified in Gastroenterology and Internal Medicine, Dr. Pichney serves on the Board of Governors of the Maryland Endoscopy Center, is President of the Maryland Society for Gastrointestinal Endoscopy, and is a Physician Member of Crohn’s & Colitis Foundation of America. She is a member of various medical associations, including Med-Chi of Maryland, Phi Beta Kappa Honor Society, Alpha Omega Alpha Honor Medical Society, American Gastroenterological Association, American Society for Gastroenterological Endoscopy, American College of Physicians, and Baltimore County Medical Association. A fellow of the American College of Physicians/ASIM and American College of Gastroenterology, Dr. Pichney has been the recipient of numerous awards, is the author of various publications and abstracts, and has presented numerous lectures.

Richard A. Desi, M.D.

Richard A. Desi, M.D., received his medical degree from the University of Maryland School of Medicine and completed his residency at the University of Maryland Department of Internal Medicine. He completed his Gastroenterology fellowship at Georgetown University Hospital. Dr. Desi is Board Certified in Internal Medicine and is Board-Eligible in Gastroenterology. He is a member of the American Gastroenterological Association and American College of Gastroenterology.

The Institute for Digestive Health and Liver Disease at Mercy is located on the 7th floor of Mercy’s Professional Office Building at 301 St. Paul Street. Call 410-332-9829 or call

1-800-M.D.-Mercy for an appointment.

Mercy Medical Center is a 134-year-old, university affiliated medical facility named one of the top 100 hospitals in the nation and among 10 best centers for women’s health care. Mercy is home to the nationally acclaimed Weinberg Center for Women’s Health and Medicine, and in 2010, will open the new $ 400 million Mary Catherine Bunting Center for inpatient care. For more information, visit Mercy online at http://www.mdmercy.com or call 1-800-M.D.-Mercy.

Editor’s note: Caption for accompanying photo, Mercy Medical Center’s Institute for Digestive Health and Liver Disease features a highly skilled and talented staff of physicians (left to right, first row): David B. Posner, M.D., Paul J. Thuluvath, M.D., Mary L. Harris, M.D., Sergey Kantsevoy, M.D., Ph.D. (left to right, back row): Lisa Pichney, M.D., Michael E. Cox, M.D., Debra A. Vachon, M.D., Patrick Hyatt, M.D., Scott Huber, M.D., and Richard A. Desi, M.D.

###

Los Angeles Community Honors Medical and Clinical Professionals at Sierra Tucson’s Fourth Annual “Gratitude for Giving” Breakfast

August 07, 2012 No comments

Tucson, AZ (PRWEB) June 08, 2011

On Wednesday, June 8, 2011, Sierra Tucson will host the Fourth Annual Los Angeles “Gratitude for Giving” Breakfast to recognize clinical professionals and others for their considerable contributions to the Los Angeles community. The breakfast and ceremony will begin at 10 a.m. at the Four Seasons Hotel Los Angeles at Beverly Hills, 300 S. Doheny Drive. Almost 300 attendees are expected to join this celebration to pay tribute to their peers. Media are invited to attend free of charge.

The following individuals will be recognized for their years of service to others:

Action Recognition – Donald J. Kurth, M.D., FASAM

Compassion Recognition – David E. Smith, M.D., FASAM, FAACT

Hope Recognition – Bill Beacham, Ph.D.

Humility Recognition – Peggy Albrecht

Pillar of the Community – Ed Storti, CADC

Resource Recognition – Catherine Scott, M.D.

Spirit Recognition – Carolyn Costin, M.A., MED, MFT

Gratitude Recognition – Jeffery N. Wilkins, M.D.

?For over 27 years, Sierra Tucson has continued to look for ways to give back to those who help so many people,” says Christi Cessna, Sierra Tucson’s Director of Clinical Outreach and Marketing. “We sponsor this inspirational event as a way to honor the passion of the recovery and behavioral health community. Clinicians typically will gather for educational purposes, but this is the only venue where we come together to honor the work that they do.?

About Sierra Tucson

Since 1983, Sierra Tucson has provided compassionate care and clinical excellence. Multi-licensed as a psychiatric hospital and residential treatment center, Sierra Tucson excels at treating coexisting disorders and has developed internationally renowned programs for Chemical Dependency, Eating Disorders, Mood and Anxiety Disorders, Pain Management, and Sexual and Trauma Recovery. The Progressions Program offers advanced tools for recovery, and in-depth Assessment Services are available on an inpatient or outpatient basis. Sierra Tucson has been awarded dual Accreditation by The Joint Commission and Pain Program Accreditation by the American Academy of Pain Management.

Located on 160 acres at the foot of the Santa Catalina Mountains near Tucson, Arizona, Sierra Tucson gives patients a beautiful, natural healing environment and the highest level of confidentiality. For more information about the unparalleled treatment provided at Sierra Tucson, call 800-842-4487 or visit SierraTucson.com.

Sierra Tucson is a member of CRC Health Group, the most comprehensive network of specialized behavioral care services in the nation. CRC offers the largest array of personalized treatment options, allowing individuals, families, and professionals to choose the most appropriate treatment setting for their behavioral, addiction, weight management, and therapeutic education needs. CRC is committed to making its services widely and easily available while maintaining a passion for delivering advanced treatment. For over two decades, CRC programs have helped individuals and families reclaim and enrich their lives. For more information, visit CRChealth.com.

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India Network Offers Visitors with Travel Medical Insurance Cardiovascular Prevention and Care

August 03, 2012 No comments

Orlando, FL (PRWEB) June 20, 2012

India Network Foundation, a non-profit US based sponsor of health insurance in the USA, announced an agreement with Thambiran Heart & Vascular Institute wherein members of India Network Foundation and their family members can receive discounted rates for preventive heart care services and comprehensive vascular health screening programs at Thambiran Heart & Vascular Institute, Chennai, India.

?Cardiovascular disease is one of the major causes of death worldwide with more than 2.5 million people expected to die due to cardiovascular disease in India. Heart disease is the cause of nearly twenty five percent of deaths in Asian Indians 25 to 70 years of age,? said Dr. R. Ravikumar, Medical Director of Thambiran Heart & Vascular Institute (P) Ltd, Chennai, India.

India Network Foundation has been at the forefront of addressing health issues of the aging Asian Indian population in the United States and elderly parents visiting from India. Life expectancy in India is improving over the years, reaching 65 years for men and 68 years for women. The life expectancy of visiting parents is much higher than the average life expectancy of India, now reaching more than 70 years of age.

In addition to offering medical insurance for travel to the US for seniors age 70 and older, the agreement with Thambiran Heart & Vascular Institute extends foundation membership benefits for preventative care. Professor KV Rao, India Network Foundation founder added, ?India Network Foundation is pleased to offer screening and health care services specifically for parents with pre existing conditions that are planning to visit the US.?

About Thambiran Heart & Vascular Institute (P) Ltd, Chennai, India

Thambiran Heart & Vascular Institute is a Heart Care Clinic in Chennai with outpatient services focused on preventive health care and comprehensive heart disease management. The hospital has been set up with a vision and mission towards ?Healthy Heart & Lengthy Life?. The Medical Director of the institute is Dr. R. Ravikumar, MBBS, DMRD, DMRE, Ph.D, Diplomate in Cardiac C.T (CBCCT, USA), Advanced Cardiovascular Imaging Fellowship (University of Toronto, Canada). Dr. Ravikumar was recently certified as a Heart Attack Prevention Specialist by Society for Heart Attack Prevention & Eradication (SHAPE), Texas, USA. He presently is a Medical Consultant at Apollo Hospitals, Madras Medical Mission, Global Hospitals etc at Chennai.

For more information visit http://www.preventheartattack.in (Shashidharan -011-91-928212978).

About India Network Foundation

India Network Foundation, established as a US non-profit organization, has been helping the Asian Indian community in North America with programs and grants to academics from India for more than two decades. India Network Foundation sponsors visitor health insurance to students, temporary workers (H1 visa holders) and their families. All insurance products sponsored by the foundation are administered by India Network Health Insurance and underwritten by The Insurance Company of the State of Pennsylvania, a member of Chartis Insurance, American International Group (AIG).

For more information visit http://www.indianetwork.org.

Medical Marketing Service Inc. Shares Successful Email Marketing Methods That Boost Open Rates by 500% and ROI by 400% at Two Leading Industry Events

August 02, 2012 No comments

Wood Dale, Illinois (PRWEB) July 27, 2012

Medical Marketing Service, Inc. (MMS) recently shared its insights regarding successful email marketing methods that can increase open rates by 500% and ROI by 400% at two leading industry conferences.

EPHARMA WEST

In the wake of the momentous Supreme Court decision affirming the Affordable Care Act, about 100 digital pharma executives gathered for the 3rd Annual ePharma West Summit, which was held July 17-19 in San Francisco.

Email marketing was on the agenda. A presentation by Terry Nugent, EVP Sales and Marketing at MMS, Inc., educated attendees about successful email marketing methods. Nugent outlined what to look for in an email ?messenger?, defined as companies such as MMS that deploy emails, and how to prepare your message so that it succeeds in its objectives. Nugent emphasized the importance of planning, including establishing quantifiable benchmarks that define success, and analyzed the top 10 and bottom 10 pharma marketing emails deployed by MMS in the past 12 months, identifying the characteristics of the successful deployments vs. the unsuccessful. To request a briefing on what it takes to create a top 10 email, contact Terry Nugent at t-nugent(at)mmslists(dot)com or 1.630.477.1553.

Other Summit sessions addressed a wide range of topics from the implications of the Supreme Court health care decision to the impact of segmentation on ROI. For an excellent summary of the proceedings blogged by James Ellis of CloserLook, go to https://workflowy.com/shared/ceb379d8-247f-0b6a-db5c-d33207e3c1d5/#/d6585882-0446-393b-3768-e65f1c4f9bca.

DIGITAL PHARMA WEST

Nugent also spoke at Digital Pharma West, during which the health reform decision news broke. Over 200 digital pharma marketers attended.

Tweets related to email marketing noted the following points:

Think about as designed vs. as rendered. Your beautiful HTML image probably will not viewable to most recipients.

You have to take the time to complete A/B testing before you send email out to all and to test on all devices.

Know your download time of images. Is an HCP going to wait for the image load in their email or delete?

Understand your target list and the types of emails will allow you to understand how the program will succeed.

Webinar emails to HCPs do very well.

Re-email to the segment that is performing best.

Open rate varies based on type of program by specialty.

Email is designed to capture attention at point a, inform and deliver the recipient to point b.

Just in time emailing works — email conference attendees with your key events the night before along with presentations.

Here is a summary of conference highlights, as indicated by the Tweeters at the meeting.

1. Supporting the Physician/Patient Relationship: Leveraging the Digital Platform to Enhance the Opportunity for Dialogue.

The event began with Pre-Conference Workshops, including an excellent seminar entitled ?Supporting the Physician/Patient Relationship: Leveraging the Digital Platform to Enhance the Opportunity for Dialogue.? Co-presenters Scott Tyson of Janssen and Beth Bengston of Hale Advisors gave a masterful overview of how to use digital media strategically. What emerged was a vision of ?Pharma 3.0? in which mobile devices are used to passively monitor patients, feed data into the electronic health record (EHR), trigger healthcare provider (HCP) interventions based on vital signs, and perhaps even adjust health insurance premiums based on therapeutic regimen and lifestyle compliance.

Those tweeting about the presentation noted 94% of EU physicians use smartphones, representing a great email opportunity!

2. Chairperson?s Opening Remarks

In the Chairperson?s opening remarks on Tuesday, June 26th, Sean O?Hagan of Daichi Sankyo cited the following statistics which were noted in tweets:

80% of US Physicians owned smartphones in 2011.

90% use digital resources during the work day

60% of physicians use digital resources during patient consultations;

There has been a 25% drop in sales reps since 2006

42% of offices with 10 or more physicians do not allow access to pharma sales representatives, making multichannel marketing including email crucial to deliver pharma promotional and educational messages.

O?Hagan noted that in today?s world, all marketers are multichannel marketers.

3. Gathering insights from consumers cost-effectively

Lauren Pennington of Pfizer spoke on gathering insights from consumers cost-effectively, generating the following tweets from the delegates:

it is possible to create a great campaign on limited budget
Pharma isn’t facing a marketing problem, it’s facing a marketing opportunity

4. Current ROI Drivers for Multi-Channel Marketing

Janssen?s Tyson made an encore the on Tuesday on a panel answering the question ?What are the Current ROI Drivers for Multi-Channel Marketing?, hosted by Mark Bard of the Digital Care Coalition. He was joined by Kelly Meyers, CEO of Qforma, and Carla Brooks, Regulatory Affairs Senior Manager, Medimmune. Those tweeting about the panel made note of several key points:

Passion and innovation are key attributes of successful digital marketers

The ROI of individual channels is difficult to ascertain, according to Tyson of Janssen, so multichannel campaign ROI must be evaluated holistically rather than by individual tactic;

“ROI” figures are soft; too many steps in the process to directly tie to sales

Be able to explain to regulatory “Why are we doing this?” Regulatory is trying to enable but wants to know what we are trying to accomplish short, medium, long run. We do more damage when we follow the ?build it & they will come? philosophy & then don?t do anything to advance that (argues for using email to promote digital solutions) – Carla Brooks, Medimmune

ROI of medium is wrong question–It’s what you do with it-Scott Tyson, Janssen. Asking the what the ROI of email is would be like asking what the ROI of a pen is – if you use it to scribble, it?s non-existent; if you use it to write the formula for the cure for cancer, it?s astronomical.

Multichannel marketing is an ecosystem of interactions. Look at your audience as a network, not as individuals. Act on the network, not the individual node to create buzz ? Kelly Myers, Qforma

For a recap by Tyler Durbin of GSW?s iQ unit, use this link: http://www.whatsyourdigitaliq.com/current-roi-drivers-for-multi-channel-marketing-digital-pharma-west/

5. The Electronic Health Record

Rich Altus, President of PDR networks noted that approximately 400,000 physicians are using electronic health records (EHRs). About 70% of large practices are using EHRs, so the growth potential is among smaller practices. Not one EHR has more than 60,000 prescribers, according to Altus.

6. Transforming relationship marketing from brand centric to enterprise-wide

Daniel Gandor of Takeda used his musical background to craft a metaphor about orchestrating the transformation of relationship marketing from a disconcerted brand-centric cacophony to an enterprise wide, customer-centric harmonious symphony.

The Twitterati shared the following key points:

Most pharma sites and email are not optimized for mobile even though HCPs are;

Takeda?s Uloric HCP relationship marketing program has 87,000 HCPs registered;

Non personal promo is taking larger role at Takeda — email is the most cost effective tactic;

A robust engagement spectrum keeps the brand in front of the physician;

We’re about to experience a shift in marketing. From a focus on the top line to the bottom line, a shift from reach to ROI.

7. Maximizing prescriber engagement in a mobile world

Epocrates hosted a panel of physicians speaking about maximizing prescriber engagement in a mobile world. Their study on digital omnivores, which found that ?3 screen? HCPs (those that use a PC, smart phone and tablet) spend more time online than single-screen users is available at http://t.co/AWtsuzDb.

One of the most notable observations was that physicians want comparative data about brands. They would have the most respect for a marketer who listed all the brands available in a particular therapeutic class and presented data comparing their product with its competitor on the basis of safety and efficacy and perhaps even cost and thus cost-effectiveness.

Other tweetable moments included:

HCPs want 3 types of content for HCPs: 1 minute, 5 minute or lots of information

Digital omnivores will more than double by Q2 2013

8. Achieving oversize results on modest budgets

Bill Drummy of Heartbeat Digital made an outstanding presentation about achieving oversize results on modest budgets. Using a David vs. Goliath motif. Drummond showed how one of his smallest clients conducted a successful campaign that used patient insights gleaned from mobile to create a breakthrough campaign in the hemophilia market by establishing genuine rapport with sufferers, who refer to themselves as bleeders, by speaking to them in their own language.

Drummy noted that digital campaigns generate up to 29:1 ROI, and that email ROI is very good. He believes that the current opportunity presented by limited budgets will act as a catalyst for adoption of digital marketing in lieu of less cost-effective tactics.

9. Mobile marketing Opportunity in Pharma

The meeting concluded with a daylong workshop on mobile marketing in pharma. Chris Ballentine of Takeda made an excellent presentation highlighting the physician-patient nexus. According to Ballentine, 70% of patients would use an app recommended by their physician, and 9 out of 10 doctors say they want to use apps to help patients manage diseases. This represents an opportunity for pharma to assist HCPs in connecting with their patients. Envision a world in which pharma emails an app link to doctors, and doctors forward it to their patients via email or even Twitter. If such aps could help patients manage diseases less expensively, it would certainly benefit all stakeholders in healthcare: patients, HCPs, and payers. There are regulatory issues. But pharma should certainly take on this challenge to move to a Pharma 3.0 model where the product is not just a pill, it is a solution to the healthcare challenge of the 21st century – achieving better quality AND reducing cost.????

10. See for yourself

All and all, it was a very educational and informative conference. A twitter transcript of the meeting is available at http://hashtags.symplur.com/healthcare-hashtag-transcript.php?hashtag=DigPharm&fdate=06-25-2012&shour=14&smin=13&tdate=06-27-2012&thour=14&tmin=13&ssec=00&tsec=00&img=1

KEEP UP WITH MMS

MMS will be speaking at future industry events on a regular basis. To find out where and when, follow us @mmsemail

ABOUT MMS

Since 1929, Medical Marketing Service, Inc. (MMS), the industry leader in healthcare lists and email marketing, has been pinpointing perfect prospects for clients including pharmaceutical marketers, continuing medical education (CME) providers, publishers, and recruiters, along with the their list brokers, ad agencies and other marketing partners. MMS?s motto is message delivered – we deliver messages to over 1.5 million healthcare professionals (HCPs).

Service is our surname for a reason – personal service by people who care and have decades of experience is the hallmark of our heritage.

Generations of satisfied customers are our legacy, and the foundation of our future – that?s why referrals are our number one source of new customers. We look forward to helping the industry meet the challenges of the 21st century – helping the industry do more with less by achieving maximum return on investment (ROI) with gold standard lists, databases and email marketing services.

MMS was the first Database Licensee of the American Medical Association (AMA), widely recognized as the finest physician database in the world, and guaranteed 99% deliverable for direct mail by MMS. Upon that foundation we have built a selection of lists that maintain that same discerning standard of excellence to reach the entire spectrum of health professionals, featuring lists of the leading healthcare professional associations in each discipline. The results of this decades-long effort to bring you the best available lists and databases are establishment of one source you can rely on for all your healthcare list and email marketing needs.

MMS allows you to reach all the critical healthcare professionals you need to succeed with an integrated, multichannel direct marketing approach that diversifies your campaigns across all media – direct mail, telemarketing, broadcast fax, and email.

For more information, go to http://www.mmslists.com, call 1.800.MED.LIST (633.5478), email sales(at)mmslists(dot)com, and follow us on Twitter @mmsemail.

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Medical Marijuana: Doobons.com Explains Options for New Patients

August 01, 2012 No comments

San Francisco, CA (PRWEB) July 14, 2012

Medical marijuana can be confusing for new patients who are unfamiliar with the industry. Doobons.com, the leading online medical cannabis resource, explains different options patients have for using cannabis to effectively treat a range of ailments.

?We are aware that new medical marijuana patients can be intimidated by the overwhelming variety of available options,? said John from Doobons. ?Our goal is to make medical marijuana easy to understand for patients who need professional, discreet answers. Something we get asked a lot about is the best method for consuming medical marijuana other than smoking.?

Doobons breaks down patients? other medical marijuana options:

Vaporizers

Vaporizing is a popular choice for inhaling medical marijuana without the harmful effects of smoking. Vaporizers heat the marijuana without burning the plant, so the patient inhales the benefits of the active compounds without all the toxins normally produced by smoking. This is a good option for patients with severe appetite loss who don?t want to smoke or cannot smoke.

Vaporizers range in size and price. Smaller battery-operated vaporizers are beneficial as a portable smokeless delivery system that can be used in places that don?t allow smoking, while the larger plug-in devices are able to produce more powerful doses.

Find more information about the benefits of vaporizers: http://www.doobons.com/blog/2012/05/25/vaporizers-prove-effective-in-treating-medical-marijuana-patients/

Pills

The medical marijuana pill Idrasil is gaining popularity as patients become more aware of their benefits. With a pill, there is no smoking or inhalation of any kind and Idrasil?s standardized 25-mg tablet delivers a consistent potency every time.

Idrasil, a product of C3 Patients Association, can be used to treat a variety of ailments and conditions such as AIDS and wasting syndrome, cancer, fibromyalgia, Crohn?s disease, Alzheimer?s disease, glaucoma, chronic pain, MS, Parkinson?s disease, sleep disorders, anxiety and depression. It can also be useful for treating chemical dependency and withdrawal symptoms.

Medical Marijuana patients share their stories with Doobons. Learn more about how one patient used Idrasil to finally overcome her Crohn?s symptoms: http://www.doobons.com/blog/2012/07/12/my-history-with-crohns-a-patients-story/

Oils

Hash oil or cannabis oil is useful for patients with more severe conditions, due to the higher potency and longer lasting effect. It is a more discreet option as well, as it can be added to food in the cooking process. The oil can also be infused in ointments, lotions, balms, or cr?mes to apply topically in order to keep a clear head and regulate the dosage.

Cannabis oil is becoming a more well-known option for cancer patients. It made headlines recently when celebrity Tommy Chong announced he is using it to treat his prostate cancer, and a couple of years ago, pediatric cancer patient Cash Hyde made significant steps towards overcoming debilitating brain tumors when his father added cannabis oil to his treatment.

Find out more about the incredible story behind the Cash Hyde Foundation (cashhydefoundation.com): http://www.doobons.com/blog/2012/05/10/doobons-com-and-the-cash-hyde-foundation-team-up-to-fight-pediatric-cancer/

Edibles

?Edibles? are foods infused with cannabis or cannabis oil that also provide a quick and appetizing alternative to smoking. The effects of eating an edible cannabis product are strong and last much longer than other options.

It may be difficult to judge the dosage with edibles, because it can take up to 60 minutes to start feeling the effects. Cannabis oil or butter can be used as a cooking ingredient in any food that contains butter and/or oil to create edible medicine.

?The main thing to remember is that having options is good,? said John. ?Tailoring your medical marijuana use to fit your needs can not only drastically improve your quality of life, but help you feel more comfortable with your medication.?

For more information about Doobons.com, call (415) 524-8099 or go to Doobons.com online.

Patients who want to share their story, please contact Doobons directly.

About Doobons.com

Doobons.com is an online medical marijuana resource for prospective and current patients, caregivers and medicinal cannabis industry professionals. The medical cannabis resource site is designed be a comprehensive source of information for everyone from novice medical cannabis users to experienced industry professionals. Doobons.com is discreet, safe and professional.

Doobons.com was designed to be convenient and to appeal to everyone, including those who are new to the world of medical cannabis. While most of today?s online medical marijuana directories are designed for patients who already know at least something about using medical marijuana, Doobons.com is a marijuana directory designed to be user friendly for patients of all ages and experience levels.

Doobons.com is more than just another online medical marijuana directory. The site?s News, Resource, and Blog pages provide valuable information and advice for patients and caregivers. The information posted helps new patients learn about the ins and outs of the world of medical marijuana, and existing patients stay abreast of developments.

The five-star-rated Doobons marijuana app is now available for free on the iTunes app store for iPhone 3GS, iPhone 4, iPhone 4S, iPod touch (3rd generation), iPod touch (4th generation) and iPad that runs on iOS 4.3 or later.

For more information about Doobons.com, call (415) 524-8099 or go to Doobons.com online.

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Tag Archives: medical

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India Network Offers Visitors with Travel Medical Insurance Cardiovascular Prevention and Care

Medical Marketing Service Inc. Shares Successful Email Marketing Methods That Boost Open Rates by 500% and ROI by 400% at Two Leading Industry Events

Medical Marijuana: Doobons.com Explains Options for New Patients

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