title: [Randomized placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients].
abstract: BACKGROUND
  We undertook a randomised controlled trial to assess the efficacy and tolerance of orlistat, a gastrointestinal lipase inhibitor, in promoting weight loss and preventing weight regain in obese patients over a 2-year period.
  
  
  METHODS
  743 patients (body-mass index 28-47 kg/m2), recruited at 15 European centres, entered a 4-week, single-blind, placebo lead-in period on a slightly hypocaloric diet (600 kcal/day deficit). 688 patients who completed the lead-in were assigned double-blind treatment with orlistat 120 mg (three times a day) or placebo for 1 year in conjunction with the hypocaloric diet. In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance (eucaloric) diet.
  
  
  RESULTS
  From the start of lead-in to the end of year 1, the orlistat group lost, on average, more bodyweight than the placebo group (10.2% [10.3 kg] vs 6.1% [6.1 kg]; LSM difference 3.9 kg [p < 0.001] from randomisation to the end of year 1). During year 2, patients who continued with orlistat regained, on average, half as much weight as those patients switched to placebo (p < 0.001). Patients switched from placebo to orlistat lost an additional 0.9 kg during year 2, compared with a mean regain of 2.5 kg in patients who continued on placebo (p < 0.001). Total cholesterol, low-density lipoprotein (LDL) cholesterol, LDL/high-density lipoprotein ratio, and concentrations of glucose and insulin decreased more in the orlistat group than in the placebo group. Gastrointestinal adverse events were more common in the orlistat group. Other adverse symptoms occurred at a similar frequency during both treatments.
  
  
  CONCLUSIONS
  Orlistat taken with an appropriate diet promotes clinically significant weight loss and reduces weight regain in obese patients over a 2-year period. The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy and adverse events.
authors.forename: L
authors.initials: L
authors.lastname: Sjostrom
authors.forename: A
authors.initials: A
authors.lastname: Rissanen
authors.forename: T
authors.initials: T
authors.lastname: Andersen
authors.forename: M
authors.initials: M
authors.lastname: Boldrin
authors.forename: A
authors.initials: A
authors.lastname: Golay
authors.forename: H
authors.initials: H
authors.lastname: Koppeschaar
authors.forename: M
authors.initials: M
authors.lastname: Krempf
mesh_terms: D000293:Adolescent; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018752:Diet, Fat-Restricted; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008049:Lipase / Q000037:antagonists & inhibitors; D008297:Male; D009765:Obesity / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy*; D000077403:Orlistat; D055502:Secondary Prevention; D015430:Weight Gain / Q000187:drug effects*
chemical_list: D019440:Anti-Obesity Agents; D015415:Biomarkers; D008078:Cholesterol, LDL; D007783:Lactones; D000077403:Orlistat; D002784:Cholesterol; D008049:Lipase