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Meridia (Sibutramine) With Low-Calorie Diet Produces Weight Loss Results in Obesity ABBOTT PARK, IL -- October 8, 2001 -- Early results from a study presented today at the annual meeting of the North American Association for the Study of Obesity (NAASO) show a combination of Meridia® (sibutramine hydrochloride monohydrate) C-IV Capsules plus a reduced-calorie diet using meal replacements in obese individuals results in weight loss compared to baseline. Following a preliminary phase of the study, the average weight loss in the 80 patients who completed three months of the study was 9.8 percent of starting body weight, or 21.5 pounds. Only two patients did not lose greater than or equal to 5 percent initial body weight. The data represent preliminary results from the study's first phase: a three-month, open-label investigation involving 151 obese patients at eight medical centers throughout the United States. All study participants received Meridia plus a low-calorie diet that included two Slim Fast® shakes and one regular meal plus lifestyle modifications. Data from 80 patients completing phase one of the study have been analyzed, and 98 percent have realized a weight loss of at least five percent of their initial body weight. "These preliminary data are encouraging for both obese individuals and the primary care doctors who are trying to help them," said Madelyn Fernstrom, Ph.D., lead author of the study and director of the Weight Management Center, UPMC Health System, Pittsburgh, and Associate Professor of Psychiatry and Epidemiology at the University of Pittsburgh. "Based on the preliminary phase of this study, we're seeing short-term results that are meaningful." At baseline, the average weight of the subjects was 216.8 pounds. Following three months of treatment, the average weight was 195.3 pounds, which is an average reduction of 21.5 pounds, or 9.8 percent (range 3.5-21.5 percent). The average waistline decrease was four and one half inches at the three-month mark. Only two of the 151 patients did not lose at least five percent of their baseline weight. All patients in the study were in good general health, ages 18-45 years and classified as clinically obese with a body mass index of 30-40 kg/m2. Those patients losing five percent or more body weight will continue into a nine-month, double-blind, randomized phase of the study. This phase, which is currently underway, will look at long-term weight loss and maintenance. "The initial results of this study are very encouraging," said Cheryl Renz, M.D., medical director, Abbott Laboratories. "Patients and physicians alike are looking for a strategy that will help obese patients adhere to a reduced-calorie diet for weight loss. The preliminary results of this study indicate that the combination of Meridia and meal replacement products may be a useful strategy." Patients cannot take Meridia if they are taking prescription medicines called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. Meridia also cannot be taken if they have anorexia, are taking other weight loss medications that act on the brain, or are hypersensitive to any of the ingredients of Meridia. Meridia substantially increases the blood pressure in some patients. Regular monitoring of blood pressure is required when taking Meridia. Meridia 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. 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. As with all medications, Meridia may not be for everyone. The most common side effects include headache, dry mouth, anorexia, constipation and insomnia. As a centrally acting prescription anti-obesity medication, Meridia is classified as a schedule IV drug. Meridia is indicated for people who need to lose 30 pounds or more depending on height, and should be used in conjunction with a reduced-calorie diet. Patients being treated with Meridia should see their doctor as directed for regular follow-up visits, during which the doctor can carefully monitor their overall health, including regular monitoring of blood pressure and pulse rate. SOURCE: Abbott Laboratories E-mail this page to a friend or colleague! To print, use this version