Weight Control and Risk Factor Reduction in Obese Subjects Treated for 2 Years With Orlistat

摘要: ContextOrlistat, a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30%, may promote weight loss and reduce cardiovascular risk factors.ObjectiveTo test the hypothesis orlistat combined with dietary intervention is more effective than placebo plus diet for weight maintenance over 2 years.DesignRandomized, double-blind, placebo-controlled study conducted from October 1992 to 1995.Setting ParticipantsObese adults (body mass index [weight in kilograms divided square of height meters], 30-43 kg/m2) evaluated at 18 US research centers.InterventionSubjects received controlled-energy diet during 4-week lead-in. On study day 1, was continued and subjects were randomized receive 3 times or orlistat, 120 mg day, for 52 weeks. After weeks, subjects began weight-maintenance diet, group (n=133) continued and orlistat-treated rerandomized times a (n=138), orlistat, 60 (n=152) or (n=153) an additional 52 weeks.Main Outcome MeasuresBody change changes blood pressure serum lipid, glucose, insulin levels.ResultsA total 1187 entered protocol, 892 were randomly assigned on 1 double-blind treatment. For intent-to-treat analysis, 223 placebo-treated 657 orlistat-treated evaluated. During first year orlistat-treated lost (mean±SEM, 8.76±0.37 kg) subjects (5.81±0.67 (P<.001). Subjects treated with year regained less (3.2±0.45 kg; 35.2% regain) than those who (4.26±0.57 kg; 51.3% regain), or (5.63±0.42 63.4% regain) Treatment with mg 3 associated improvements fasting low-density lipoprotein cholesterol levels.ConclusionsTwo-year treatment diet significantly promotes loss, lessens regain, improves some obesity-related disease factors.