Effects of sibutramine on body weight and serum lipids: A double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia

Background Cardiovascular risk factors associated with obesity, including d yslipidemia, can be improved by weight loss. The main dyslipidemia associat ed with obesity is elevated serum triglyceride and decreased serum high-den sity lipoprotein cholesterol (HDL-C) levels. Methods A total of 322 obese patients (body mass index greater than or equa l to 27) with serum triglyceride levels greater than or equal to 250 mg/dL and less than or equal to 1000 mg/dL and serum HDL-C levels less than or eq ual to 45 mg/dL (women) and less than or equal to 40 mg/dL (men) were place d on a step I American Heart Association diet and subsequently randomized t o sibutramine 20 mg (n = 162) or placebo (n = 160) once daily for 24 weeks. Results Patients taking sibutramine had significantly greater mean weight l oss than those receiving placebo (-4.9 kg vs -0.6 kg, P less than or equal to .05). Forty-two percent of the sibutramine group lost greater than or eq ual to5% of baseline weight and 12% lost greater than or equal to 10% compa red with 8% and 3%, respectively, of the placebo group (P less than or equa l to .05). Mean decreases in serum triglyceride levels among 5% and 10% wei ght-loss responders in the sibutramine group were 33.4 mg/dL and 72.3 mg/dL , respectively, compared with an increase of 31.7 mg/dL among all patients receiving placebo (P less than or equal to .05). Mean increases in serum HD L-C levels for 5% and 10% weight-loss responders in the sibutramine group w ere 4.9 mg/dL and 6.7 mg/dL, respectively, compared with an increase of 1.7 mg/dL among all patients in the placebo group (P less than or equal to .05 ). Adverse events and discontinuation rates were similar in the sibutramine and placebo groups, although sibutramine-treated patients had mean increas es in systolic and diastolic blood pressure of 2 to 3 mm Hg relative to pla cebo. Conclusions In overweight and obese patients with high serum triglyceride l evels and low serum HDL-C levels, treatment with sibutramine was associated with significant improvements in body weight and in serum triglyceride and HDL-C levels.