title: A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial.
abstract: BACKGROUND
  Lorcaserin is a novel selective agonist of the serotonin 2C receptor.
  
  
  OBJECTIVE
  Our objective was to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese and overweight patients.
  
  
  METHODS
  This randomized, placebo-controlled, double-blind, parallel arm trial took place at 97 U.S. research centers.
  
  
  METHODS
  Patients included 4008 patients, aged 18-65 yr, with a body mass index between 30 and 45 kg/m(2) or between 27 and 29.9 kg/m(2) with an obesity-related comorbid condition.
  
  
  METHODS
  Patients were randomly assigned in a 2:1:2 ratio to receive lorcaserin 10 mg twice daily (BID), lorcaserin 10 mg once daily (QD), or placebo. All patients received diet and exercise counseling.
  
  
  METHODS
  The ordered primary endpoints were proportion of patients achieving at least 5% reduction in body weight, mean change in body weight, and proportion of patients achieving at least 10% reduction in body weight at 1 yr. Serial echocardiograms monitored heart valve function.
  
  
  RESULTS
  Significantly more patients treated with lorcaserin 10 mg BID and QD lost at least 5% of baseline body weight (47.2 and 40.2%, respectively) as compared with placebo (25.0%, P < 0.001 vs. lorcaserin BID). Least squares mean (95% confidence interval) weight loss with lorcaserin BID and QD was 5.8% (5.5-6.2%) and 4.7% (4.3-5.2%), respectively, compared with 2.8% (2.5-3.2%) with placebo (P < 0.001 vs. lorcaserin BID; least squares mean difference, 3.0%). Weight loss of at least 10% was achieved by 22.6 and 17.4% of patients receiving lorcaserin 10 mg BID and QD, respectively, and 9.7% of patients in the placebo group (P < 0.001 vs. lorcaserin BID). Headache, nausea, and dizziness were the most common lorcaserin-related adverse events. U.S. Food and Drug Administration-defined echocardiographic valvulopathy occurred in 2.0% of patients on placebo and 2.0% on lorcaserin 10 mg BID.
  
  
  CONCLUSIONS
  Lorcaserin administered in conjunction with a lifestyle modification program was associated with dose-dependent weight loss that was significantly greater than with placebo.
authors.affiliation: Arena Pharmaceuticals San Diego, California 92121, USA.
authors.forename: Meredith C
authors.initials: MC
authors.lastname: Fidler
authors.forename: Matilde
authors.initials: M
authors.lastname: Sanchez
authors.forename: Brian
authors.initials: B
authors.lastname: Raether
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.forename: Steven R
authors.initials: SR
authors.lastname: Smith
authors.forename: William R
authors.initials: WR
authors.lastname: Shanahan
authors.forename: Christen M
authors.initials: CM
authors.lastname: Anderson
mesh_terms: D015502:Absorptiometry, Photon; D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000453:epidemiology; D004311:Double-Blind Method; D004452:Echocardiography; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy*; D050177:Overweight / Q000150:complications / Q000188:drug therapy*; D044405:Receptor, Serotonin, 5-HT2C / Q000187:drug effects; D012307:Risk Factors; D018401:Sample Size; D058826:Serotonin 5-HT2 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D015431:Weight Loss / Q000187:drug effects*; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D001552:Benzazepines; D008055:Lipids; D044405:Receptor, Serotonin, 5-HT2C; D058826:Serotonin 5-HT2 Receptor Agonists; C506658:lorcaserin