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| |  ECO MEETING: Meridia Helps Maintain Long-Term Weight Loss MT. OLIVE, NJ -- June 4, 1999 -- Early results from the second phase of the STORM study - Sibutramine Trial in Obesity Reduction and Maintenance -- released today at the European Congress on Obesity in Milan suggest that Knoll Pharmaceutical Co.’s Meridia(R) (sibutramine hydrochloride monohydrate) C-IV Capsules are effective in helping most people maintain initial six-month weight loss for up to two years. According to the study, 67 percent of people taking Meridia maintained more than a five percent weight loss (compared to 49 percent in placebo group) and 37 percent maintained more than a 10 percent weight loss (compared to 19 percent in the placebo group). "There was a significant difference between the active agent and a placebo in the STORM study that has important clinical benefits," said Arne Astrup, M.D., Ph.D., STORM investigator and professor of human nutrition at the Royal Veterinary and Agricultural University of Denmark. For many people, maintaining weight loss is a difficult task. "Maintenance is essential for realising the health and psychological benefits of initial weight loss,” said Kelly Brownell, Ph.D., director of the Yale Center for Eating and Weight Disorders at Yale University in New Haven, CT. “Without the right tools, regain of lost weight can be an all too common experience." Meridia works by affecting chemicals in the brain involved in regulating appetite and helps people overcome one of the biggest barriers to losing weight, because it helps them feel full so they can eat less -- a feeling also known as satiety. Since its launch in February 1998, Meridia has been taken by more than one million people in the U.S. Obesity is a chronic disease affecting 38 million people in the United States. People who are obese are at an increased health risk for associated diseases including type II diabetes, high blood pressure, heart disease, osteoarthritis and certain cancers. According to scientific studies, a weight loss of five to 10 percent in excess body weight in obese patients, followed by maintenance of that loss, can reduce risk factors and provide health benefits. Successful, long-term weight reduction and maintenance requires incorporation of lifestyle changes and behaviour modification into a person's daily life. "Usually we say that an acceptable weight loss is five percent, and that five to 10 percent is highly beneficial in terms of cardiovascular risk factors and co-morbidities, which were all going in the right direction in this study,” said STORM investigator, Nick Finer, M.D., with the Centre for Obesity Research at Luton and Dunstable Hospital. Clinical studies with Meridia have shown it to be a well tolerated, safe and effective weight management medication with the majority of people losing between five and 10 percent of their body weight. Early findings from the STORM study appear to reconfirm previous studies showing weight loss and maintenance of weight loss. "These interim STORM results show that this anti-obesity compound is much more effective than we had hoped," Astrup said. The two-phase STORM study assessed the effect of Meridia on achieving and maintaining weight loss in obese people for up to two years. The study was conducted in eight European centres including Aberdeen, Copenhagen, Antwerp, London, Luton, Maastricht and Stockholm. The first phase of the study, presented at the International Congress on Obesity in Paris last summer, Phase II of the study included those patients who had lost more than five percent of their initial body weight during the first phase. These patients were studied for a further 18-months in a double-blind placebo controlled fashion with 352 people receiving Meridia and 115 patients receiving placebo. Both groups participated in the same intensive weight management program. Meridia is indicated for the management of obesity, including weight loss and maintenance of weight loss when used in conjunction with a reduced-calorie diet. Meridia is recommended for patients with an initial BMI (body mass index -- weight in kilograms divided by height in meters squared) greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 in the presence of other risk factors (such as hypertension, diabetes and dyslipidemia). Meridia is taken once a day without regard to meals. Meridia is well tolerated, and most side effects are mild and temporary and include dry mouth, headache, insomnia and constipation. Meridia substantially increases blood pressure in some people and for this reason regular blood pressure monitoring is required when taking the drug. These blood pressure increases generally occur early in treatment and the prescribing physician may decide to decrease the dose of Meridia or discontinue the medication. In clinical trials, the number of patients who discontinued Meridia use because of hypertension was less than one-half of one percent and was comparable to placebo. The drug should be given with caution to those patients with a history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension. As a centrally-acting prescription anti-obesity medication, Meridia is classified as a schedule IV drug. Data on the efficacy of Meridia beyond one year of use have not yet been evaluated by the U.S. Food and Drug Administration. Related Links: Meridia, Knoll Pharmaceutical Co.
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