Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity

Objective: To determine the effect of orlistat, a new lipase inhibitor, on long-term weight loss, to determine the extent to which orlistat treatment minimizes weight regain in a second year of treatment, and to assess the ef fects of orlistat on obesity-related risk factors. Research Methods and Procedures: This was a 2-year, multicenter, randomized , double-blind, placebo-controlled study. Obese patients (body mass index 2 8 to 43 kg/m(2)) were randomized to placebo or orlistat (60 or 120 mg) thre e times a day, combined with a hypocaloric diet during the first year and a weight maintenance diet in the second year of treatment to prevent weight regain. Changes in body weight, lipid profile, glycemic control, blood pres sure, quality of life, safety, and tolerability were measured. Results: Orlistat-treated patients lost significantly more weight (p < 0.00 1) than placebo-treated patients after Year 1 (6.6%, 8.6%, and 9.7% for the placebo, and orlistat 60 mg and 120 mg groups, respectively). During the s econd year, orlistat therapy produced less weight regain than placebo (p = 0.005 for orlistat 60 mg; p < 0.001 for orlistat 120 mg). Several obesity-r elated risk factors improved significantly more with orlistat treatment tha n with placebo. Orlistat was generally well tolerated and only 6% of orlist at-treated patients withdrew because of adverse events. Orlistat leads to p redictable gastrointestinal effects related to its mode of action, which we re generally mild, transient, and self-limiting and usually occurred early during treatment. Discussion: Orlistat administered for 2 years promotes weight loss and mini mizes weight regain. Additionally, orlistat therapy improves lipid profile, blood pressure, and quality of life.