title: Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE).
abstract: BACKGROUND
  Rimonabant treatment, examined in Phase 3 trials, showed improvement of cardiovascular risk factors in obese patients.
  
  
  OBJECTIVE
  The objective of this Phase 4 trial is to assess the effectiveness of rimonabant plus lifestyle counselling when used in daily practice, namely in the general practice. The hypothesis was that the effectiveness in Phase 4 would be smaller than the efficacy in Phase 3 due to different patient selection and treatment conditions. At the end of this trial, rimonabant was suspended of all markets due to psychiatric side effects.
  
  
  METHODS
  This trial randomly assigned 222 patients with enlarged waist circumferences and hyperglycaemia or diabetes mellitus type 2, recruited from Dutch general practices, to double-blinded therapy with either placebo or rimonabant (20 mg/day) for 1 year in addition to lifestyle counselling.
  
  
  RESULTS
  Compared with placebo, the rimonabant group showed significant improvements in body weight, body mass index, high-density lipoprotein (HDL) cholesterol and the main outcome waist circumference after 1 year. The United Kingdom Prospective Diabetes Study risk calculation showed no significant difference. The rimonabant group showed statistically deterioration, compared with the placebo group, in the quality of life in the EuroQol and two domains of the SF-36: role limitations due to physical health problems and bodily pain.
  
  
  CONCLUSIONS
  The unique real life data of this Phase 4 trial showed that the effectiveness of rimonabant in daily practice is indeed lower than in controlled circumstances (Phase 3). Rimonabant treatment showed improvement of obesity and the HDL cholesterol, but had no positive effect on the other cardiovascular risk factors and the quality of life.
authors.affiliation: Department of General Practice, School for Public Health and Primary Care (CAPHRI), Maastricht University Medical Centre, Maastricht, The Netherlands. jolienboesten@hag.unimaas.nl
authors.forename: Jolien E J
authors.initials: JE
authors.lastname: Boesten
authors.forename: Janneke
authors.initials: J
authors.lastname: Kaper
authors.forename: Henri E J H
authors.initials: HE
authors.lastname: Stoffers
authors.forename: Abraham A
authors.initials: AA
authors.lastname: Kroon
authors.forename: Onno C P
authors.initials: OC
authors.lastname: van Schayck
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000517:prevention & control; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D011320:Primary Health Care; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D000077285:Rimonabant; D040242:Risk Reduction Behavior; D056737:Safety-Based Drug Withdrawals; D006113:United Kingdom; D055105:Waist Circumference / Q000187:drug effects; D055815:Young Adult
chemical_list: D019440:Anti-Obesity Agents; D010880:Piperidines; D011720:Pyrazoles; D000077285:Rimonabant