Orlistat in the long-term treatment of obesity in primary care settings

Objective: To evaluate the long-term efficacy and tolerability within prima ry care settings of orlistat, a gastrointestinal lipase inhibitor, for the treatment of obesity. Design: Randomized, double-blind, placebo-controlled, multicenter study. Participants: A group of 796 obese patients (body mass index, 30-44 kg/m(2) ), treated with placebo 3 times a day (TID), 60 mg of orlistat TID, or 120 mg of orlistat TID, in conjunction with a reduced-energy diet for the first year and a weight-maintenance diet during the second year. Setting: Seventeen primary care centers in the United States. Main Outcome Measures: Changes in body weight and obesity-related disease r isk factors. Results: Patients treated with orlistat lost significantly more weight (7.0 8 +/- 0.54 and 7.94 +/- 0.57 kg for the 60-mg and 120-mg orlistat groups, r espectively) than those treated with placebo (4.14 +/- 0.56 kg) in year 1 ( P<.001) and sustained more of this weight loss during year 2 (P<.001). More patients treated with orlistat lost 5% or more of their initial weight in year 1 (48.8% and 50.5% of patients in the 60-mg and 120-mg groups, respect ively) compared with placebo (30.7%; P<.001), and approximately 34% of pati ents in the orlistat groups sustained weight loss of 5% or greater over 2 y ears compared with 24% in the placebo group (P<.001). Orlistat produced gre ater improvements than placebo in serum lipid levels and blood pressure and was well tolerated, although treatment resulted in a higher incidence of g astrointestinal events. Conclusions: This long-term study indicates that orlistat is an effective a djunct to dietary intervention in the treatment of obesity in primary care settings.