Long-term maintenance of weight loss with sibutramine in a GP setting following a specialist guided very-low-calorie diet: a double-blind, placebo-controlled, parallel group study

Abstract

Very-low-calorie diets (VLCDs) are used to promote short-term weight loss in obese patients. However, long-term maintenance of weight loss is generally poor. We assessed the efficacy and safety of sibutramine in maintaining weight loss achieved in obese patients by means of a 3-month VLCD. A multicenter double-blind, parallel-group trial conducted over 18 months, following a 3-month open label VLCD run-in. Eight hospital centers in The Netherlands, with subsequent follow-up in general practice. A total of 221 obese subjects, of whom 189 were randomized (mean screening BMI 36.6 kg/m(2); mean age 42.6 y). Patients were given a 3-month VLCD and were required to lose 10% or more of their initial weight. A total of 189 patients completed this phase (mean percentage weight loss 14.5+/-3.2%) and were randomized to sibutramine 10 mg/day (n=94) or matching placebo (n=95). All patients received a recommended diet and exercise program. The primary analysis was outcome in terms of achieving 80% weight maintenance of the VLCD period at month 18. Secondary analysis was percentage of initial weight loss maintained at months 6, 12, 18 and end point. At month 18, the odds ratio for achieving successful weight maintenance was 1.76 (95% CI 1.06, 2.93) in favor of sibutramine (P=0.03). In intention-to-treat analysis, more than 80% of the weight loss achieved during the VLCD phase was maintained by 70, 51 and 30% of sibutramine-treated patients at months 6, 12 and 18, respectively, compared to 48, 31 and 20% of placebo-treated patients. The differences between the treatment groups were significant (P< or =0.03) at all time points. Weight loss achieved with a VLCD is more effectively maintained with sibutramine in combination with a recommended diet and exercise program than with placebo over a follow-up period of 18 months. Sibutramine is well tolerated, with a safety profile consistent with that seen in other previous trials.