new england journal of medicine The established in 1812 September 20, 2018 vol. 379 no. 12 Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients E.A. Bohula, S.D. Wiviott, D.K. McGuire, S.E. Inzucchi, J. Kuder, K.A. Im, C.L. Fanola, A. Qamar, C. Brown, A. Budaj, A. Garcia‑Castillo, M. Gupta, L.A. Leiter, N.J. Weissman, H.D. White, T. Patel, B. Francis, W. Miao, C. Perdomo, S. Dhadda, M.P. Bonaca, C.T. Ruff, A.C. Keech, S.R. Smith, M.S. Sabatine, and B.M. Scirica, for the CAMELLIA–TIMI 61 Steering Committee and Investigators* a bs t r ac t BACKGROUND Lorcaserin, a selective serotonin 2C receptor agonist that modulates appetite, has proven efficacy for weight management in overweight or obese patients. The cardiovascular safety and efficacy of lorcaserin are undefined. METHODS We randomly assigned 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to receive either lorcaserin (10 mg twice daily) or placebo. The primary safety outcome of major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) was assessed at an interim analysis to exclude a noninferiority boundary of 1.4. If noninferiority was met, the primary cardiovascular efficacy outcome (a composite of major cardiovascular events, heart failure, hospitalization for unstable angina, or coronary revascularization [extended major cardiovascular events]) was assessed for superiority at the end of the trial. RESULTS At 1 year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) in the placebo group (odds ratio, 3.01; 95% confidence interval [CI], 2.74 to 3.30; P
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