7. XENICAL: Long-Term Clinical Trials
The XENICAL phase III program is the largest for an obesity drug. The program comprised seven double-blind, placebo-controlled, multicenter clinical studies (four U.S. studies, three European studies). Four of the seven studies were of 2 years' duration. Three of the seven studies included evaluation of weight regain. One of the studies focused on the efficacy of XENICAL in obese patients with diabetes. The program was developed on the premise that XENICAL should be evaluated not only in terms of weight but also in terms of those conditions known to be associated with or aggravated by obesity. The intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and had body weight measurements before and after randomization.
8. Mean Weight Loss over Time: XENICAL Plus Diet vs. Placebo Plus Diet
In this study, weight change was comparable in the two groups during the 4-week placebo plus diet lead-in period (about 5 to 6 lbs). A noticeable difference in weight loss between the two groups began to emerge as early as 4 weeks after randomization. At 1 year, weight loss was significantly greater in the XENICAL group, with a 10.2% decrease from initial body weight compared with a 6.1% decrease in the placebo group (P<0.001). Weight loss over 1 year was significantly greater with XENICAL plus diet compared with placebo plus diet in all clinical studies.
