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 dyslipidemia, can be improved by weight loss. The main dyslipidemia associated with obesity is elevated serum triglyceride and decreased serum high-density lipoprotein cholesterol (HDL-C) levels. Methods A total of 322 obese patients (body mass index greater than or equal 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 equal to 45 mg/dL (women) and less than or equal to 40 mg/dL (men) were placed on a step I American Heart Association diet and subsequently randomized to sibutramine 20 mg (n = 162) or placebo (n = 160) once daily for 24 weeks. Results Patients taking sibutramine had significantly greater mean weight loss 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 equal to5% of baseline weight and 12% lost greater than or equal to 10% compared with 8% and 3%, respectively, of the placebo group (P less than or equal to .05). Mean decreases in serum triglyceride levels among 5% and 10% weight-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 HDL-C levels for 5% and 10% weight-loss responders in the sibutramine group were 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 increases in systolic and diastolic blood pressure of 2 to 3 mm Hg relative to placebo. Conclusions In overweight and obese patients with high serum triglyceride levels 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.