To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Dose-Related Weight Loss With Meridia Improves Cholesterol Levels URL: http://www.pslgroup.com/dg/EB8E6.htm Doctor's Guide March 10, 1999
MOUNT OLIVE, NJ -- March 10, 1999 -- The largest published, multi-centre clinical trial for any currently available prescription weight management medication in the U.S., with more than 1,000 participants, is detailed in this month's edition of the journal Obesity Research. The trial establishes that a majority of patients taking Knoll Pharmaceutical Co.'s Meridia(R) (sibutramine hydrochloride monohydrate) C-IV Capsules lost a significant amount of weight and the amount of weight lost was directly related to the dose of medication. Almost 60 percent of patients taking 10 milligrams (mg) of Meridia once daily, the recommended starting dose, lost five percent or more of their weight during the study. Weight loss of five to 10 percent was also accompanied by improvements in lipid profiles including a four percent increase in beneficial high-density lipoprotein (HDL) cholesterol and a 12 percent decrease in triglycerides. Additionally, low-density lipoprotein (LDL) and total cholesterol were reduced by more than four percent. "This study confirms the significant link between the dose level of Meridia and the product's efficacy," said study co-author George Blackburn, M.D., Ph.D., Centre for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Centre, Harvard Medical School. "This clinical trial represents the first of a whole new era of comprehensive evaluation for obesity pharmacotherapy at multiple doses. Also, the health benefits tied to improvements in cholesterol levels add significance to these findings." 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. Since its launch in February 1998, Meridia has been used by more than 600,000 patients in the U.S. and physicians have written more than 1.3 million prescriptions. Meridia helps address one of the biggest barriers for consumers beginning a weight-loss program: feeling full, so they can eat less. Obesity is a growing public health problem in America. Some 55 percent of all U.S. adults are overweight or obese, affecting more than 97 million Americans. 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). Capsules are available in 5, 10, and 15 mg strengths. The study objective was to demonstrate the efficacy and safety of Meridia across a wide range of doses. Seven centres nation-wide participated in the study in which 1,047 men and women ranging in age from 18 to 65 years with a BMI between 30 and 40 kg/m2 were enrolled. Following a two-week placebo run-in period, patients were randomly assigned in a double-blind manner to Meridia in strengths of 1, 5, 10, 15, 20 and 30 mg or placebo once daily in the morning for six months (24 weeks). (The current FDA-approved doses of Meridia are the 5, 10 and 15 mg capsules.) The study was followed by a six-week placebo wash-out period. All patients had regular medical check-ups which included measurement of body weight, blood pressure and pulse rate. In addition, all study participants received a one-time consultation with a dietician which included instructions for following a daily low-calorie diet (1,200 kilocalories for women and 1,500 kilocalories for men), behavioural modification techniques and recommendations for an exercise program (walking 20 to 30 minutes per day). This level of intervention mimics real world patient experience more closely than that in many other weight reduction trials. The study demonstrates a statistically significant dose-related response in terms of percent change in weight for patients compared to placebo. Meridia was well-tolerated at all strengths. The study confirmed that patients who lost four pounds or more in the first four weeks of treatment were most likely to benefit from long-term treatment with Meridia. In this study, the most common treatment-related adverse events were dry mouth, anorexia and insomnia. Discontinuation for hypertension occurred in one percent of patients in the placebo group, in up to two percent of patients treated with Meridia up to 20 mg and in five percent of the patients treated with 30 mg of Meridia. The tachycardia discontinuation rate was one percent for the placebo group and up to three percent for all Meridia groups. The adverse events discontinuation rate was eight percent for placebo and 11 percent for all study participants. Weight loss in the Meridia group was accompanied by statistically significant improvements in blood lipid profiles and uric acid, including a decrease in total triglycerides, LDL and total cholesterol and an increase in HDL (good) cholesterol. Blood glucose (sugar) levels, an indicator of insulin resistance related to type II diabetes, also improved in patients who lost weight with Meridia. "This resulting decrease in cholesterol levels may have far-reaching health benefits in decreasing the risk of coronary heart disease. Each one percent decrease in cholesterol is expected to result in a two percent decrease in CHD and, independently, each mg/dl increase in HDL cholesterol is expected to result in a two to three percent decrease in CHD," stated Donna Ryan, M.D., a study co-author and obesity specialist at Pennington Biomedical Research Centre. In clinical trials among more than 6,000 individuals, including 4,000 obese patients, Meridia has been shown to be a safe and effective product. Meridia is well-tolerated and most side effects are mild and temporary and include dry mouth, headache, insomnia and constipation. Meridia can substantially increase blood pressure in some people and for this reason regular blood pressure monitoring is required when taking Meridia. 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. 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. As a centrally-acting prescription anti-obesity medication, Meridia is classified as a schedule IV drug. Related Links: Meridia, Knoll Pharmaceutical Co., Doctor's Guide to Obesity --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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