The results of the ongoing cardiovascular outcomes trial (CAMELLIA TIMI 61) will determine the role of lorcaserin in primary prevention of diabetes in overweight/obese individuals and its use in the high-risk population of patients with established cardiovascular disease or multiple cardiovascular risk factors. Therapeutic efficacy should be assessed at 12 weeks (≥ 5% weight loss) to identify responders who will derive maximum weight loss and metabolic benefit from long-term therapy. In the CAMELLIA-TIMI 61 study, which was presented as a late-breaking clinical trial and published August 26, 2018, in the New England Journal of Medicine, investigators randomized 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to treatment with lorcaserin or placebo. At therapeutic doses, it is well tolerated and produces modest but clinically meaningful weight loss with significant improvement in cardiometabolic parameters. EXPERT OPINION: Lorcaserin is a unique highly selective serotonergic agonist designed to mitigate the risks associated with previous agents in this class. AREAS COVERED: In this paper, the pharmacodynamic and pharmacokinetic properties of lorcaserin are reviewed followed by a discussion of efficacy and safety data from major clinical trials. Lorcaserin is a serotonergic agonist specific to the 5HT- 2C receptor approved for chronic management of obesity in patients with a BMI ≥ 30 kg/m(2) or a BMI ≥ 27 kg/m(2) with comorbidities related to obesity. CAMELLIATIMI 61 was a randomized, double- blind, placebo-controlled, multinational clinical trial in which patients at 473 sites in eight coun - tries underwent randomization. Sjstrm L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, Krempf M. The trial examined the safety and efficacy of the drug with regard to major adverse cardiovascular events. doi: 10.1056/NEJMp2003873 Crossref Medline Google Scholar 19. The CAMELLIA-TIMI 61 trial was conducted as part of the FDAs postmarketing requirement. INTRODUCTION: Obesity is a major health priority necessitating safe and effective strategies to address the obesity epidemic. Cancer risk associated with Lorcaserin The FDA’s Review of the CAMELLIA-TIMI 61 Trial. In the CAMELLIA-TIMI 61 cohort, a small increase in cancer was noted in the treatment group, which has led the FDA to request Eisai, the manufacturer. Lorcaserin Hcl for the treatment of obesity. Announces Positive Topline Results from CAMELLIA-TIMI 61, a Large-Scale Cardiovascular Outcome Trial for the Anti-Obesity Agent BELVIQ®.
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