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Weight Control and Risk Factor Reduction in Obese Subjects Treated for 2 Years With Orlistat: A Randomized Controlled Trial.
Davidson, Michael H. MD; Hauptman, Jonathan MD; DiGirolamo, Mario MD; Foreyt, John P. PhD; Halsted, Charles H. MD; Heber, David MD; Heimburger, Douglas C. MD; Lucas, Charles P. MD; Robbins, David C. MD; Chung, Jain PhD; Heymsfield, Steven B. MD
[Article] JAMA. 281(3):235-242, January 20, 1999.

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Context: Orlistat, a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30%, may promote weight loss and reduce cardiovascular risk factors.

Objective: To test the hypothesis that orlistat combined with dietary intervention is more effective than placebo plus diet for weight loss and maintenance over 2 years.

Design: Randomized, double-blind, placebo-controlled study conducted from October 1992 to October 1995.

Setting and Participants: Obese adults (body mass index [weight in kilograms divided by the square of height in meters], 30-43 kg/m2 ) evaluated at 18 US research centers.

Intervention: Subjects received placebo plus a controlled-energy diet during a 4-week lead-in. On study day 1, the diet was continued and subjects were randomized to receive placebo 3 times a day or orlistat, 120 mg 3 times a day, for 52 weeks. After 52 weeks, subjects began a weight-maintenance diet, and the placebo group (n=133) continued to receive placebo and orlistat-treated subjects were rerandomized to receive placebo 3 times a day (n=138), orlistat, 60 mg (n=152) or 120 mg (n=153) 3 times a day, for an additional 52 weeks.

Main Outcome Measures: Body weight change and changes in blood pressure and serum lipid, glucose, and insulin levels.

Results: A total of 1187 subjects entered the protocol, and 892 were randomly assigned on day 1 to double-blind treatment. For intent-to-treat analysis, 223 placebo-treated subjects and 657 orlistat-treated subjects were evaluated. During the first year orlistat-treated subjects lost more weight (mean /- SEM, 8.76 /- 0.37 kg) than placebo-treated subjects (5.81 /- 0.67 kg) (P<.001). Subjects treated with orlistat, 120 mg 3 times a day, during year 1 and year 2 regained less weight during year 2 (3.2 /- 0.45 kg; 35.2% regain) than those who received orlistat, 60 mg (4.26 /- 0.57 kg; 51.3% regain), or placebo (5.63 /- 0.42 kg; 63.4% regain) in year 2 (P<.001). Treatment with orlistat, 120 mg 3 times a day, was associated with improvements in fasting low-density lipoprotein cholesterol and insulin levels.

Conclusions: Two-year treatment with orlistat plus diet significantly promotes weight loss, lessens weight regain, and improves some obesity-related disease risk factors.

JAMA.1999;281:235-242