Each year more than 1 million babies born prematurely before 37 weeks of development in the womb or within the first month of life the “March of Dimes said Sunday in the first comprehensive global report on premature births,” CNN reports. Nearly 10 percent of total births worldwide, or 12.9 million infants, are preterm, the study found (10/4).

“The problem is concentrated in poor countries, with the vast majority of … premature babies born each year in Africa and Asia [based on total numbers], according to the report,” the Associated Press/ New York Times writes (10/4). In Africa, 11.9 percent of babies are born premature, followed by North America (10.6 percent), Asia (9.1 percent), Latin America and the Caribbean (8.1 percent), Australia and New Zealand Trustedtablets (6.4 percent) and Europe (6.2 percent), the Washington Post reports (Brown, 10/5).

The report notes, “Wherever trend data are available, rates of preterm birth are increasing.” In addition, “babies who survive premature birth face lifelong health risks, including the possible development of cerebral palsy, blindness, hearing loss, learning disabilities and other chronic conditions, according to the March of Dimes,” CNN writes (10/4).

Christopher Howson, a March of Dimes researcher who worked on the report, said that not much is known about the causes of preterm birth in the developing world. But he said malnutrition, malaria, anemia and inadequate prenatal care are probably contributing factors, the Washington Post reports (10/5).

According to Agence FrancePresse, Jennifer Howse, March of Dimes president, said, “If world leaders are serious about reaching the United Nations Millennium Development Goals to reduce child mortality and improve maternal health, then strategies and funding for reducing death and disability related to preterm birth must receive priority” (10/4).

The new paper includes data from the WHO Bulletin. In a March of Dimes/EurekAlert! release, the organization said the WHOs “figures are conservative = counting only singleton preterm births, for example and likely underestimates the true magnitude of the worldwide crisis of preterm birth” (10/4).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

The study

Over a period of two years, 30 scientist lead by Associate Professor Peter Krustrup, University of Copenhagen, have investigated physiological, sociological and psychological aspects of womens soccer in comparison to running. 100 untrained adult premenopausal women have participated in the study.

The women (65 participated in the physiological study) were randomly divided into three groups One soccer group, one running group and one control group. The soccer players and runners trained twice a week for one hour. After four and sixteen weeks, all the subjects went through extensive physiological tests. The same 65 subjects + another 35 women playing in soccer clubs were continually observed and interviewed to study the sociological and psychological effects of their training.

Soccer players stick to their game

Many women find it difficult to fit in sport and exercise in their busy daily lives, and many state family and especially small children as the main reason for not finding the time.

The study reveals that contrary to common assumption, the flexibility of running as exercise form actually makes running harder to stick to for most women than soccer, which requires a fixed time and place.

“What is really interesting is that the soccer players differed from the runners in their motivation. The runners were motivated by the idea of getting in shape and improving health. But the soccer players focused on the game itself and were motivated by the social interaction and by having fun with others. As it turns out, the soccer players got in better shape than the runners, and that combined with the social benefits makes soccer a great alternative to running”, says Associate Professor Laila Ottesen and continues

“The women who played soccer have continued their soccer training as a group whereas few of the women in the running group continued running after the study. Actually, some of the women from the running group joined teams with the soccer group after the project finished.”

Why soccer players are more fit

When choosing a sport, women tend to favour cardiovascular training to strength training although the buildup of muscles and bone strength are vital to preserve health into old age.

“While playing soccer, the women have high heart rates and perform many sprints, turns, kicks and tackles, making soccer an effective integration of both cardio and strength training”, says project leader Peter Krustrup.

“Our study shows that the 16 weeks of recreational womens soccer causes marked improvement in maximal oxygen uptake, muscle mass and physical performance, including the endurance, intermittent exercise and sprinting ability, explains Peter Krustrup, and continues, “This makes soccer a very favourable choice of exercise training for women.

In the recent decade, we have seen a significant rise in women and girls playing soccer. It seems as though women are really beginning to take in soccer and make it a popular sport for women on their own terms. This is a very positive step forward, not only because of the improved physical fitness and health profile but also for the enjoyment of sports”, Krustrup concludes.

Publication plans

The present results will be submitted online in the highlevel international journal Scandinavian Journal of Medicine and Science in Sports next week (Bangsbo, Nielsen, Mohr, Randers, Krustrup, Brito, Nybo and Krustrup. Performance enhancements and muscular adaptations of a 16week recreational football intervention for untrained women. Scand J Med Sci Sports, 2009).

In January 2010, the same journal will publish a supplementum describing multiple health effects of recreational football for various subject groups, including men, women, young and elderly. The supplementum includes one review and 13 original scientific papers.

The data will also be presented at the Scandinavian Congress of Medicine and Science in Sports 2010, Copenhagen, Denmark, 46 February 2010, and at the 3rd International Football Medicine Conference in Sun City, South Africa, 1921 February 2010.

The project group currently includes collaborators from Switzerland, Norway and Italy, and major applications are currently being processed to include collaborators from England, Portugal, Belgium, Australia and Kenya.

Funding
The work has been financially supported by FMARC, The Danish Ministry of Culture, The Danish Football Association and The Danish Sport Federation, The Danish Gymnastics and Sports Associations and by 3F (United Federation of Danish Workers).

Source
Peter Krustrup

New research demonstrates the importance of treating pregnant women with even the mildest forms of gestational diabetes to reduce healthcare risks for both infants and mothers.

Dr. Mark Landon, lead investigator of the multicenter study, and a team of investigators from the Eunice Kennedy Shriver National Institute of Child Health and Human Development conducted a clinical trial to determine if a benefit existed to diet intervention and frequent glucose monitoring in the management of mild gestational diabetes.

The results appear in todays (Oct. 1) issue of The New England Journal of Medicine.

“Treatment is prescribed on a regular basis for most women with gestational diabetes. But we have lacked the evidence until now as to whether treatment of the mildest cases would benefit, or pose risks for, mothers or their newborns,” says Landon, who is also interim chair of obstetrics and gynecology at The Ohio State University Medical Center. “The study confirms that it is worth the time and effort to treat women with even the mildest form of glucose intolerance during pregnancy.”

In most cases of gestational diabetes, a woman receives her diagnosis during pregnancy, and the diabetes does not persist after pregnancy. However, these women have a higher chance of being diagnosed again with adult onset diabetes later in life.

This randomized study included 958 women at 15 medical centers, half receiving treatment for their mild gestational diabetes, and half receiving the usual prenatal care.

Women who received treatment in the study were half as likely to deliver babies with excess body fat and were half as likely to experience shoulder dystocia at birth, occurring when a babys shoulders are caught in the maternal pelvis after delivery of the infants head. The women with treatment also had fewer cesarean deliveries and less preeclampsia, or hypertensive disorders of pregnancy.

The treatment involved a diet plan, together with close monitoring using a portable meter. If a woman in the study received treatment, she performed at least four glucose tests per day, during her fasting and after meals, to be certain that the diet therapy was keeping her blood glucose within the desired target range. Of the women treated, 93 percent were managed with diet intervention alone, whereas only 7 percent required insulin injections to control blood sugar.

If a woman has elevated blood sugar levels during pregnancy, the fetus may also experience high blood sugar levels. As a result, the fetus makes extra insulin, which can lead to excess body fat. Previous studies have suggested that larger babies have an increased frequency of longterm complications such as childhood diabetes and a risk for type II diabetes throughout their lifetime, according to Landon.

“The condition of gestational diabetes may affect up to 14 percent of all U.S. pregnancies,” says Landon. “Recent studies have indicated that the frequency of gestational diabetes is, in fact, increasing in the United States and worldwide. Because of the increasing frequency of gestational diabetes, our study importantly gives hope to affected women that the condition is generally manageable, with dietetic modifications and close monitoring during pregnancy. Considering the potential downstream effects on the infants, treatment at this stage might serve to control the amount of diabetes in the future.”

The study was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal Fetal Medicine Units Network a part of the National Institutes of Health in addition to the NIHs National Center for Research Resources.

For broadcast quality soundbites and broll of this story, please contact OSU Medical Center Media Relations.

Source Ohio State University Medical Center

Solace Therapeutics, Inc., a medical device company focused on the development of nonsurgical bladder control therapies announced that it has received European CE mark approval for the Solace Intravesical System, and ISO 134852003 certification for the companys Framingham facility. The company is introducing its first product, an officebased therapy for Female Stress Urinary Incontinence at the International Continence Society Meeting in San Francisco on Friday, October 2, 2009.

“This certification and CE mark approval represent a significant achievement and major milestone for Solace,” said Kevin Connors, chief executive officer of Solace Therapeutics. “Successfully completing this process allows us to move forward with the clinical development of the Solace Intravesical System in Europe.

Solace is introducing its first product, a nonsurgical therapy for women with Stress Urinary Incontinence, to ICS members at their annual meeting on Friday. “Solace is targeting those patients that are dissatisfied with current therapies and choose to manage their urinary leakage with absorbent pads or diapers,” said Connors. “Solace has developed a new option for these patients.”

The Solace Balloon is a small lightweight device (about the size of a quarter) that floats within the urinary bladder. It acts as a “shock absorber” to reduce the temporary pressure changes in the bladder that cause urinary leakage. It is placed in the bladder with a soft tubelike catheter and inflated with air. The 5 minute procedure is performed in the physicians office without anesthesia or surgery. No lifestyle change is required after the procedure, and the procedure is reversible at any time.

The Solace Balloon for women with involuntary urine leakage is currently being evaluated in several centers throughout the U.S. in an FDA IDE approved clinical trial.

About Solace Therapeutics

Solace Therapeutics is an emerging medical device company focused on the development of nonsurgical office based treatments for common bladder disorders, such as stress urinary incontinence (SUI), overactive bladder (OAB), male voiding dysfunction and lower urinary tract symptoms (LUTS). Solace is dedicated to improving the patients quality of life by eliminating side effects typically associated with current drug and surgical therapies. Solaces proprietary technology is designed to offer patients the following benefits

Officebased therapy that does not require anesthesia or surgery

No lifestyle change required, before or after treatment

Reversible at any time

Solaces patented technology platform is based on the fundamental fluid mechanics principles of reducing rapid pressure changes in fluid with airbased pressure attenuation. Solace is the pioneer of applying these principles to treat bladder dysfunction.

Source Solace Therapeutics, Inc

Drug companies are sprinting ahead in a race against the clock to deliver millions of doses of vaccine for the H1N1 influenza virus before cooler weather ushers in the 20092010 flu season. A twopart cover story in the current issue of Chemical & Engineering News, ACS weekly newsmagazine, focuses on that topic and efforts to develop antiviral drugs for flu infections.

C&EN senior correspondent Ann Thayer cites World Health Organization (WHO) estimates that onethird of the worlds population 2.2 billion people will be exposed to the H1N1 virus. Although antiviral drugs can help limit the spread of H1N1, a vaccine offers the best means to prevent infection, the article notes.

Although the H1N1 virus just emerged in April, vaccine developers have made an effective vaccine. However, WHO says that only a fraction of the potential supply will be ready for distribution before flu season starts in October in the Northern Hemisphere. The article describes how at least nine countries have pledged to donate vaccines to help fight the pandemic in developing countries and two vaccine manufacturers have earmarked a portion of their production for developing countries. That generosity will help protect populations that otherwise would not have access to vaccines, the article notes.

ARTICLE
“Flu Vaccine Race against the Clock”
This twopart story is available at
pubs.acs.org/cen/coverstory/87/8739cover.html
pubs.acs.org/cen/coverstory/87/8739cover2.html

Source
Michael Woods

The Diabetes UK Media Relations Team was a proud finalist for the Third Sector Excellence Awards in the category of Communications Team.

The other finalists competing for one of the sectors most prestigious awards were the Childrens Society (the winner), Crimestoppers Trust, EveryChild and Macmillan Cancer Support.

Winners were announced at an awards ceremony on 24 September at the Grosvenor House Hotel in London.

Fantastic achievement

“Its fantastic to have made it through to the final stages of such a prestigious award,” said Paul McDonald, Head of Media at Diabetes UK.

A recently published study determined that women who make poor shoe choices early in life suffer with foot pain in later years. Research shows that men do not experience the same foot pain as women, due to type of shoes they wear. Details of this study appear in the October issue of Arthritis Care & Research, a journal published by WileyBlackwell on behalf of the American College of Rheumatology.

National data reveal that foot and toe symptoms are among the top 20 reasons patients ages 6574 visit their physician. In the U.S., foot pain is considered a very common musculoskeletal symptom and occurs in such conditions as rheumatoid arthritis, diabetes, and gout, or with sprains, muscle strains, bruises, and fractures. Previous studies have determined a correlation between improper footwear and foot pain, but this research focused on small patient samples or disease specific studies.

Researchers from Boston University School of Public Health and the Institute for Aging Research at Hebrew SeniorLife enrolled 3,372 participants in the Framingham Foot Study. Participants were derived from 2 large populationbased samples of residents from Framingham, Massachusetts. The first group was part of the Framingham Study Original Cohort (formed in 1948) and the Framingham Offspring Cohort (formed in 1972) that were originally studied for heart disease risk factors. The second group was a new population sample derived from census data and included subjects who were at least 50 years old and ambulatory who were added to increase participation by minority persons.

The Framingham Foot Study assessed 1,472 men and 1,900 women between 2002 and 2008. Subjects were asked if they experienced pain, aching, or stiffness in either or both feet. Data on specific areas of foot pain was identified in the nails, forefoot, hindfoot, heel, arch of the foot, and ball of the foot. Participants provided information on current and past shoewear across five age groups 2029 years, 3044 years, 4564 years, 6574 years, and 75+ years. Shoewear was classified as good (low risk shoes including athletic and casual sneakers), average (mid risk shoes such as hard or rubbersoled shoes, special shoes and work boots), and poor shoes (highrisk shoewear that lack support and sound structure, including highheeled shoes, sandals, and slippers).

According to the study 25% of participants reported generalized foot pain on most days with 19% of men and 29% of women falling into this subtype. “In women, we found an increased risk between hindfoot pain and shoewear,” said the authors. The study revealed that only a small percentage (< 2%) of men wore poor shoes, thus shoe type is not a major factor for developing foot pain in men. "While more research is needed, young women should make careful choices regarding their shoe type to avoid hindfoot pain later in life, or perform stretching exercises to alleviate the effect of high heels on foot pain," recommended researchers.

Citation
“Foot Pain Is Current or Past Shoewear a Factor?”
Alyssa B. Dufour, Kerry E. Broe, Anne H. Walker, Erin Kivell, UyenSa D.T. Nguyen, Marian T. Hannan, David R. Gagnon, Howard J. Hillstrom.
Arthritis Care & Research; Published Online September 29, 2009 (DOI 10.1002/art.24733); Print Issue Date October 2009.

Additional countries are expected to soon announce they will follow in the footsteps of nine developed countries who recently said they would donate H1N1 (swine flu) vaccine supplies to poorer nations, David Nabarro, of the U.N. said Friday, Reuters reports.

“It is most likely that there will be other countries donating 10 percent of their H1N1 vaccine stocks,” Nabarro said. Nabarro declined to name who the new donors would be, according to Reuters. A report released last week concluded “85 developing countries would have to rely entirely on donations for vaccine supplies,” the news service writes (Evans, 9/25).

VOA News reports the WHO also continues to solicit vaccine donations and reduced prices on H1N1 vaccines from pharmaceutical companies (Schlein, 9/25). In related news, Daily Nation/allAfrica.com reports Kenya will soon receive four million doses of H1N1 vaccine from the WHO (9/25).

H1N1Related Deaths Near 4,000
Also on Friday, the WHO reported that over 3,900 people have died from H1N1 “a jump of 431 deaths compared to a week ago,” according to Agence FrancePresse/the Australian. “The Americas region continued to post the highest number of fatal cases, at 2948,” the news service writes (9/25).

H1N1 Moves Through South Africa, Zimbabwe, Mexico

In South Africa, the number of H1N1related deaths climbed to 59, according to a spokesperson from the National Institute of Communicable Diseases, BuaNews reports (9/25). ZimOnline examines the rising number of H1N1 cases in Zimbabwe, “where health facilities have collapsed after a decade of economic recession” (Nyamhangambiri, 9/26).

The Associated Press/Detroit Free Press reports on the “next wave” of H1N1 in Mexico. Despite “[d]aily diagnoses reach[ing] higher levels in September than the H1N1 peak in April, with 483 new cases in just one day this month alone,” the news service writes, “Its unlikely there will be largescale closings of schools and stadiums … because health officials know the virus is benign if treated early” (9/27).

No Major Changes In H1N1 Virus, U.S. Health Officials Say

HealthDay News/Atlanta JournalConstitution reports that U.S. health officials on Friday reported there were no major changes in the genetic composition of the H1N1 virus, “making the forthcoming vaccine a good match for the virus” and signifying the virus has not mutated into a deadlier form (9/25).

News Outlets Explore U.S. Efforts To Track Adverse Effects Of H1N1 Vaccine

AP examines the U.S. system to track H1N1 vaccinerelated side effects. The article includes information about several governmentfunded projects that will help stay on top of the outcomes of people who take the H1N1 vaccine (Neergaard, 9/27). The New York Times also features a piece on how the government is preparing to separate commonly occurring medical events from events that can be linked back to being a side effect of the H1N1 vaccine. The CDC “has compiled data on how many problems like heart attacks, strokes, miscarriages, seizures and sudden infant deaths normally occur” and “has broken those figures down for various highpriority vaccine groups, like pregnant women or children with asthma,” the newspaper writes, adding, “When vaccinations begin, it plans to gather reports from vaccine providers, hospitals and doctors, looking for signs of adverse events, so it can detect problems before rumors grow” (McNeil, 9/27).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

The U.S. Food and Drug Administration approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

“This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor selfimage for people who are selfconscious about their appearance,” said Julie Beitz, M.D., director, Office of Drug Evaluation III, in the FDAs Center for Drug Evaluation and Research.

Stelara is a monoclonal antibody, a laboratoryproduced molecule that mimics the bodys own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

Three studies of 2,266 patients evaluated the biologics safety and effectiveness.

Since Stelara reduces the immune systems ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.

The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

Stelara is manufactured by Centocor Ortho Biotech Inc. of Horsham, Pa., a whollyowned subsidiary of Johnson & Johnson of New Brunswick, N.J.

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agencys (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as addon to insulin for the treatment of type 2 diabetes. If adopted by the European Commission, sitagliptin will be the only diabetes treatment in the DPP4 inhibitor class to have an indication for use as addon to insulin in the European Union.

In the United States, JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. JANUMET and JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The labeling for both JANUVIA and JANUMET state that they have not been studied in combination with insulin.

In the United States, a supplemental New Drug Application (sNDA) that is similar to the European proposal concerning the use JANUVIA and JANUMET in combination with insulin has been accepted by the U.S. Food and Drug Administration (FDA) and is currently under review. The use of JANUVIA and JANUMET in combination with insulin is investigational in the U.S.

Sitagliptin is a selective, oncedaily DPP4 inhibitor that enhances a natural body system called the incretin system to help regulate blood sugar by increasing levels of active GLP1 and GIP hormones; it inhibits DPP4 over 24 hours. The fixeddose combination of sitagliptin and metformin targets all three key defects of diabetes insulin deficiency from pancreatic beta cells, hepatic insulin resistance, and overproduction of glucose by the liver. Sitagliptin is the first approved medicine in the DPP4 inhibitor class of oral treatments. It has been approved in more than 80 countries, and to date there have been more than 15 million prescriptions dispensed worldwide.

Selected cautionary information for JANUVIA

JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis and angioedema. As is typical with other antihyperglycemic 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. 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. 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. Safety and effectiveness of JANUVIA in pediatric patients have not been established. There are no adequate and wellcontrolled 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 postmarketing reports of hypersensitivity reactions in patients treated with JANUVIA. These reactions include anaphylaxis, angioedema and exfoliative skin conditions including StevensJohnson 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 antidiabetic drug.

Selected Adverse Reactions for JANUVIA

In controlled clinical studies as both monotherapy and combination therapy with metformin or pioglitazone, the overall incidences 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 (≥5 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.

In a prespecified pooled analysis of two monotherapy studies, an addon to metformin study, and an addon to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia in patients treated with JANUVIA 100 mg was similar to placebo (1.2 percent vs. 0.9 percent). Adverse reactions of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. In an additional, 24week, placebocontrolled factorial study of initial therapy with sitagliptin in combination with metformin, the incidence of hypoglycemia was 0.6 percent in patients given placebo, 0.6 percent in patients given sitagliptin alone, 0.8 percent in patients given metformin alone and 1.6 percent in patients given sitagliptin in combination with metformin.

Selected cautionary information for JANUMET

The labeling for JANUMET contains a boxed warning for lactic acidosis, a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with JANUMET. JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis. JANUMET should be avoided in patients with evidence of hepatic disease. Before initiation of therapy with JANUMET and at least annually thereafter, renal function should be assessed and verified as normal. Patients should be warned against excessive alcohol intake while receiving JANUMET. Patients may require discontinuation of JANUMET and temporary use of insulin during periods of stress and decreased intake of fluids and food such as may occur with fever, trauma, infection or surgery. Patients previously controlled on JANUMET who develop laboratory abnormalities or clinical illness should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patientyears, with approximately 0.015 fatal cases/1000 patientyears). When lactic acidosis occurs, it is fatal in approximately 50 percent of cases.

Metformin and sitagliptin are known to be substantially excreted by the kidney. The risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive JANUMET. In the elderly, JANUMET should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging can be associated with reduced renal function. Any dose adjustment should be based on a careful assessment of renal function. Before initiation of therapy with JANUMET and at least annually thereafter, renal function should be assessed and verified as normal.

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin, one of the components of JANUMET. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including StevensJohnson 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 sitagliptin, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUMET, assess for other potential causes for the event, and institute alternative treatment for diabetes.

As is typical with other antihyperglycemic agents used in combination with a sulfonylurea, when sitagliptin was used in combination with metformin and a sulfonylurea or a sulfonylurea alone, a medication known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo in combination with metformin and a sulfonylurea. Therefore, patients on sitagliptin also receiving an insulin secretagogue (e.g., sulfonylurea, meglitinide) may require a lower dose of the insulin secretagogue to reduce the risk of hypoglycemia.

Clinicians should be mindful that hypoglycemia could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucoselowering agents (such as sulfonylureas and insulin) or ethanol. Elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUMET or any other oral antidiabetic drug.

Selected Adverse Reactions for JANUMET

The most common adverse reactions reported in >/= 5 percent of patients started simultaneously on sitagliptin and metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache.

About Merck

Merck & Co., Inc. is a global researchdriven 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 farreaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a notforprofit service.

ForwardLooking Statement

This press release contains “forwardlooking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on managements current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forwardlooking statements may include statements regarding product development, product potential or financial performance. No forwardlooking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forwardlooking statement, whether as a result of new information, future events, or otherwise. Forwardlooking statements in this press release should be evaluated together with the many uncertainties that affect Mercks business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Mercks Form 10K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Companys periodic reports on Form 10Q or current reports on Form 8K, which the Company incorporates by reference.

JANUVIA is a registered trademark of Merck & Co., Inc., Whitehouse Station, New Jersey, USA