Efficacy and safety of sibutramine in obese white and African American patients with hypertension - A 1-year, double-blind, placebo-controlled, multicenter trial

Background: Obesity is a highly prevalent medical condition and is commonly accompanied by hypertension. This study assessed the efficacy and safety o f treatment with sibutramine hydrochloride for promoting and maintaining we ight loss in obese patients with controlled hypertension, including a subse t analysis of African American patients. Patients and Methods: Obese patients with a body mass index (BMI, calculate d as weight in kilograms divided by the square of height in meters) between 27 and 40 and a history of hypertension controlled with a calcium channel blocker (with or without concomitant thiazide diuretic treatment) were rand omized to receive sibutramine (n=150) or placebo (n=74) with minimal behavi oral intervention for 52 weeks. African Americans constituted 36% of enroll ed patients. Efficacy assessments were body weight and related parameters ( BMI and waist and hip circumferences), metabolic parameters (serum levels o f triglycerides, high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol, glucose, and uric acid) , and quality-of-life measures. Safety assessments included recording of bl ood pressure, pulse rate, adverse events, and reasons for discontinuation. Results: For patients receiving sibutramine, weight loss occurred during th e first 6 months of the trial and was maintained to the end of the 12-month treatment period. Among patients receiving sibutramine, 40.1% lost 5% or m ore of body weight (5% responders) and 13.4% lost 10% or more of body weigh t (10% responders) compared with 8.7% and 4.3% of patients in the placebo g roup, respectively (P<.05). Changes in body weight were similar among Afric an Americans and whites. Sibutramine-induced weight loss was associated wit h significant improvements in serum levels of triglycerides, HDL-C, glucose , and uric acid. Waist circumference and quality-of-life measures also impr oved significantly in patients receiving sibutramine. Sibutramine-treated p atients had small but statistically significant mean increases in diastolic blood pressure (2.0 mm Hg) and pulse rate (4.9 beats/min) compared with pl acebo-treated patients (-1.3 mm Hg and 0.0 beats/min; P<.05); these changes were similar among African Americans and whites. Most adverse events were mild to moderate in severity and transient. The most common adverse event r esulting in discontinuation among patients receiving sibutramine was hypert ension (5.3% of patients receiving sibutramine vs 1.4% of patients receivin g placebo). Conclusions: In obese patients with controlled hypertension, sibutramine wa s an effective and well-tolerated treatment for weight loss and maintenance . Sibutramine-induced weight loss resulted in improvements in serum levels of triglycerides, HDL-C, uric acid, and glucose, and in waist circumference and quality-of-life measures. Blood pressure and heart rate increased by a small amount. Efficacy and safety profiles for sibutramine among African A merican and white obese patients with controlled hypertension were similar.