title: Safety and tolerability review of lorcaserin in clinical trials.
abstract: Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM-DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycaemia, back pain, cough and fatigue in patients with diabetes. In a pooled analysis of echocardiographic data collected during the three lorcaserin Phase III trials, the incidence of FDA-defined valvulopathy was similar in patients taking lorcaserin and the placebo. Here, the safety profile of lorcaserin at the FDA-approved dose of 10 mg twice daily is reviewed using data from the lorcaserin Phase III programme, with a focus on theoretical adverse events commonly associated with agonists of the serotonin receptor family. Based on the lorcaserin Phase III clinical trial data, lorcaserin is safe and well tolerated in the indicated patient populations.
authors.affiliation: Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA. Frank.Greenway@pbrc.edu.
authors.forename: F L
authors.initials: FL
authors.lastname: Greenway
authors.affiliation: Formerly of Arena Pharmaceuticals, Inc., San Diego, CA, USA.
authors.forename: W
authors.initials: W
authors.lastname: Shanahan
authors.affiliation: Formerly of Eisai Inc., Woodcliff Lake, NJ, USA.
authors.forename: R
authors.initials: R
authors.lastname: Fain
authors.affiliation: Formerly of Eisai Inc., Woodcliff Lake, NJ, USA.
authors.forename: T
authors.initials: T
authors.lastname: Ma
authors.affiliation: Washington Center for Weight Management and Research, Arlington, VA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Rubino
mesh_terms: D019440:Anti-Obesity Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001552:Benzazepines / Q000009:adverse effects* / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D004038:Diet, Reducing; D015444:Exercise; D006261:Headache; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism / Q000628:therapy; D050177:Overweight / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism / Q000628:therapy; D044405:Receptor, Serotonin, 5-HT2C / Q000737:chemistry / Q000378:metabolism; D058826:Serotonin 5-HT2 Receptor Agonists / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D019440:Anti-Obesity Agents; D001552:Benzazepines; D044405:Receptor, Serotonin, 5-HT2C; D058826:Serotonin 5-HT2 Receptor Agonists; C506658:lorcaserin
keywords: Lorcaserin; obesity; safety; weight loss