title: Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials.
abstract: To evaluate the effects of lorcaserin in patients with pre-existing Food and Drug Administration (FDA)-defined valvulopathy.
  
  
  
  This is a pooled, post hoc analysis of three Phase 3 studies. BLOOM and BLOSSOM patients were 18 to 65 years of age without diabetes and with a body mass index (BMI) of 27 to 29.9 kg/m2and ≥1 weight-related comorbidity or a BMI of 30 to 45 kg/m2. BLOOM-DM patients had a BMI of 27 to 45 kg/m2and type 2 diabetes. Patients were treated with placebo, lorcaserin 10 mg once daily, or lorcaserin 10 mg twice daily. Serial echocardiographs were obtained at baseline and every 6 months.
  
  
  
  Included patients (N = 169) had FDA-defined valvulopathy at baseline and a week 52 echocardiogram. At week 52, 35.5% and 52.7% of patients experienced changes from baseline in aortic and mitral regurgitation, respectively. Numerically greater proportions of patients taking lorcaserin versus placebo had decreases in aortic (33.0% vs. 28.3%) or mitral (41.3% vs. 36.7%) regurgitation. Fewer patients taking lorcaserin versus placebo had increases in aortic (2.8% vs. 6.7%) or mitral (8.3% vs. 21.7%) regurgitation. No adverse event-related discontinuation was due to a valve problem.
  
  
  
  These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre-existing FDA-defined valvulopathy.
authors.affiliation: MedStar Health Research Institute, Washington, DC, USA.|Regulatory Science, Georgetown University School of Medicine, Washington, DC, USA.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.affiliation: Center for the Metabolic Origins of Disease, Sanford Burnham Prebys Medical Discovery Institute, Orlando, Florida, USA.|Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, Florida, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Smith
authors.affiliation: Mallinckrodt Pharmaceuticals, Hampton, New Jersey, USA.
authors.forename: Randi
authors.initials: R
authors.lastname: Fain
authors.affiliation: Medical and Scientific Affairs, Eisai Inc., Woodcliff Lake, New Jersey, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Hall
authors.affiliation: Anthera Pharmaceuticals, Inc, Hayward, California, USA.
authors.forename: William R
authors.initials: WR
authors.lastname: Shanahan
mesh_terms: D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000008:administration & dosage*; D001022:Aortic Valve Insufficiency / Q000150:complications / Q000188:drug therapy*; D001552:Benzazepines / Q000008:administration & dosage*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D015431:Weight Loss / Q000187:drug effects
chemical_list: D019440:Anti-Obesity Agents; D001552:Benzazepines; C506658:lorcaserin