Lorcaserin

The

n e w e ng l a n d j o u r na l

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m e dic i n e

original article

Multicenter, Placebo-Controlled Trial of Lorcaserin for Weight Management
Steven R. Smith, M.D., Neil J.Weissman, M.D., Christen M. Anderson, M.D., Ph.D., Matilde Sanchez, Ph.D., Emil Chuang, M.D., Scott Stubbe, M.B.A., Harold Bays, M.D., William R. Shanahan, M.D., and the Behavioral Modification andLorcaserin for Overweight and Obesity Management (BLOOM) Study Group

A bs t r ac t
BACKGROUND

Lorcaserin is a selective serotonin 2C receptor agonist that could be useful in reducing body weight.METHODS

In this double-blind clinical trial, we randomly assigned 3182 obese or overweight adults (mean body-mass index [the weight in kilograms divided by the square of the height in meters] of36.2) to receive lorcaserin at a dose of 10 mg, or placebo, twice daily for 52 weeks. All patients also underwent diet and exercise counseling. At week 52, patients in the placebo group continued toreceive placebo but patients in the lorcaserin group were randomly reassigned to receive either placebo or lorcaserin. Primary outcomes were weight loss at 1 year and maintenance of weight loss at 2years. Serial echocardiography was used to identify patients in whom valvulopathy (as defined by the Food and Drug Administration) developed.
RESULTS

From the Translational Research Institute forMetabolism and Diabetes, Florida Hospital and the Sanford–Burnham Institute, Winter Park, FL (S.R.S.); MedStar Health Research Institute at Washington Hospital Center and Georgetown University,Washington, DC (N.J.W.); Arena Pharmaceuticals, San Diego, CA (C.M.A., M.S., E.C., S.S., W.R.S.); and the Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY (H.B.). Address reprintrequests to Dr. Smith at the Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford–Burnham Institute, 2566 Lee Rd., Winter Park, FL 32789, or at steven.r.smith...