title: Early weight loss while on lorcaserin, diet and exercise as a predictor of week 52 weight-loss outcomes.
abstract: OBJECTIVE
  To identify an early treatment milestone that optimizes sensitivity and specificity for predicting ≥5% weight loss at Week (W) 52 in patients with and without type 2 diabetes on lorcaserin or placebo.
  
  
  METHODS
  Post hoc area under the curve for receiver operating characteristic analyses of data from three phase 3 trials comparing lifestyle modification+placebo with lifestyle modification+lorcaserin. A total of 6897 patients (18-65 years; BMI, 30-45 or 27-29.9 kg/m(2) with ≥1 comorbidity) were randomized to placebo or lorcaserin 10 mg bid. Changes (baseline to W52) in cardiometabolic parameters were assessed.
  
  
  RESULTS
  Response (≥5% weight loss from baseline) at W12 was a strong predictor of W52 response. Lorcaserin patients with a W12 response achieved mean W52 weight losses of 10.6 kg (without diabetes) and 9.3 kg (with diabetes). Proportions achieving ≥5% and ≥10% weight loss at W52 were 85.5% and 49.8% (without diabetes), and 70.5% and 35.9% (with diabetes). Lorcaserin patients who did not achieve a W12 response lost 3.2 kg (without diabetes) and 2.8 kg (with diabetes) at W52. Responders had greater improvements in cardiometabolic risk factors than the modified intent-to-treat (MITT) population, consistent with greater weight loss.
  
  
  CONCLUSIONS
  ≥5% weight loss by W12 predicts robust response to lorcaserin at 1 year.
authors.affiliation: Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, Florida, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Smith
authors.forename: Patrick M
authors.initials: PM
authors.lastname: O'Neil
authors.forename: Arne
authors.initials: A
authors.lastname: Astrup
authors.forename: Nicholas
authors.initials: N
authors.lastname: Finer
authors.forename: Matilde
authors.initials: M
authors.lastname: Sanchez-Kam
authors.forename: Kyle
authors.initials: K
authors.lastname: Fraher
authors.forename: Randi
authors.initials: R
authors.lastname: Fain
authors.forename: William R
authors.initials: WR
authors.lastname: Shanahan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000494:pharmacology* / Q000627:therapeutic use; D019540:Area Under Curve; D001552:Benzazepines / Q000494:pharmacology* / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004032:Diet; D015444:Exercise; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D017063:Outcome Assessment, Health Care; D015431:Weight Loss / Q000187:drug effects*; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D001552:Benzazepines; C506658:lorcaserin