Sibutramine (Meridia) Produces and Maintains Long-Term Weight Loss: Results of Two Pivotal Studies

Abstract

LEARNING OUTCOME: To establish the efficacy of sibutramine (MERIDIA) for long-term weight management. Sibutramine hydrochloride (MERIDIA, Knoll Pharmaceutical Co.), a novel serotonin and norepinephrine reuptake inhibitor, was evaluated for the long-term treatment of obesity. Two multicenter, double-blind, placebo-controlled, parallel-group studies were conducted in uncomplicated obese patients to evaluate the weight-reducing efficacy of sibutramine in conjunction with dietary advice. The first study included 1047 adults with a body mass index (BMI) of 30 to 40 kg/m 2 who received once-daily sibutramine (1, 5, 10, 15, 20, or 30 mg) or placebo for 6 months. Study 2 included 485 adults with a BMI of 27 to 40 kg/m 2 who were randomized to receive once-daily sibutramine (10 or 15 mg) or placebo for 1 year. In the first study, a dose-response relationship was observed with sibutramine for absolute and percent weight loss, and BMI. Sibutramine significantly reduced weight at all doses ( p<0.05) and BMI ( p<0.05) (last-observation-carried-forward analyses, LOCF) at all doses except 1 mg compared with placebo. Paralleling weight loss were significant dose-related reductions in observed waist circumference at doses >10 mg compared with placebo ( p<0.05). Decreases in total cholesterol, LDL cholesterol, and triglycerides, and increases in HDL cholesterol also were seen in patients who lost weight with sibutramine. In study 2, treatment with sibutramine (10 and 15 mg) over 1 year produced a significant reduction in mean weight compared with placebo ( p<0.01). A statistically significant reduction in BMI ( p< 0.001) and waist circumference ( p<0.05) was observed at both doses. After 1 year (LOCF), 39% and 57% of patients taking sibutramine 10 and 15 mg, respectively, lost <5% of baseline body weight compared with 20% of the placebo group ( p< 0.001); 19% and 34% of patients taking sibutramine 10 and 15 mg, respectively, lost >10% of baseline body weight compared with 7% of patients in the placebo group ( p<0.01). These studies demonstrate the efficacy of once-daily sibutramine for long-term management of obesity, including weight loss and maintenance of weight loss.