Lancet article questions orlistat
This article was originally published in The Tan Sheet
Executive Summary
"Antiobesity drug trials powered to show clinically important reductions in major obesity-related morbidity and mortality should be required either before these drugs are approved for widespread use or as a condition of ongoing approval, authors of an article in the Jan. 6 Lancet say. Raj S. Padwal, M.D., et al. review data on orlistat, sibutramine and rimonabant, noting all three are "limited by modest efficacy and low rates of persistence with treatment." Drugs "that improve surrogate endpoints such as weight loss might not necessarily improve endpoints judged to be more clinically relevant," so higher-powered trials are needed to adequately gauge risk/benefit, they say. Aside from bariatric surgery, "which is neither a feasible nor a desirable population-based treatment for obesity, no intervention has produced consistent effective long-term weight loss," the authors note. GlaxoSmithKline received an "approvable" letter in April for alli, a 60 mg dose of orlistat, for OTC sale to consumers 18 years old and up (1"The Tan Sheet" April 10, 2006, p. 8)...
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