title: A comparative study of five centrally acting drugs on the pharmacological treatment of obesity.
abstract: BACKGROUND
  No long-term studies have compared centrally acting drugs for treating obesity.
  
  
  OBJECTIVE
  To compare the efficacy and safety of diethylpropion (DEP), fenproporex (FEN), mazindol (MZD), fluoxetine (FXT) and sibutramine (SIB) in promoting weight loss.
  
  
  METHODS
  A prospective, randomized, placebo (PCB)-controlled study conducted at a single academic institution.
  
  
  METHODS
  A total of 174 obese premenopausal women.
  
  
  METHODS
  Participants randomly received DEP 75 mg (n=28), FEN 25 mg (n=29), MZD 2 mg (n=29), SIB 15 mg (n=30), FXT 20 mg (n=29) or PCB (n=29) daily over 52 weeks. Diet and physical activity were encouraged.
  
  
  METHODS
  The primary endpoints were changes in body weight and the proportion of women who achieved at least 5% weight loss by week 52 in the intent-to-treat population. Other measurements included anthropometry, safety, metabolic and cardiovascular parameters.
  
  
  RESULTS
  Weight loss was greater than PCB (-3.1±4.3 kg) with DEP (-10.0±6.4 kg; P<0.001), SIB (-9.5±5.9 kg; P<0.001), FEN (-7.8±6.9 kg; P<0.01) and MZD (-7.4±4.9 kg; P<0.01) but not with FXT (-2.5±4.1 kg). Ten (33.3%) women lost⩾5% of their initial weight with PCB, compared with 20 (71.4%; P<0.001) with DEP, 20 (69%; P<0.02) with FEN, 21 (72.4%; P<0.01) with MZD, 22 (73.3%; P<0.001) with SIB and 10 (35.5%) with FXT. Each medically treated group experienced more adverse events compared with PCB (P<0.001). Compared with PCB, constipation was more prevalent with DEP, SIB and MZD (P<0.01); anxiety was more prevalent with DEP (P=0.01); and irritability occurred more frequently with DEP and FEN (P=0.02). Significant improvements in the depression and anxiety scores, binge-eating episodes and quality of life correlated with weight loss.
  
  
  CONCLUSIONS
  The centrally acting drugs DEP, FEN, MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women, with a satisfactory benefit-risk profile.
authors.affiliation: Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
authors.forename: H
authors.initials: H
authors.lastname: Suplicy
authors.affiliation: Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
authors.forename: C L
authors.initials: CL
authors.lastname: Boguszewski
authors.affiliation: Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
authors.forename: C M C
authors.initials: CM
authors.lastname: dos Santos
authors.affiliation: Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
authors.forename: M
authors.initials: M
authors.lastname: do Desterro de Figueiredo
authors.affiliation: Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
authors.forename: D R
authors.initials: DR
authors.lastname: Cunha
authors.affiliation: Endocrine Division (SEMPR), Department of Internal Medicine, Parana Federal University, Curitiba, Brazil.
authors.forename: R
authors.initials: R
authors.lastname: Radominski
mesh_terms: D000328:Adult; D000662:Amphetamines / Q000627:therapeutic use*; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D015992:Body Mass Index; D001938:Brazil; D003503:Cyclobutanes / Q000627:therapeutic use*; D004038:Diet, Reducing; D004053:Diethylpropion / Q000627:therapeutic use*; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008454:Mazindol / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy* / Q000517:prevention & control; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D000662:Amphetamines; D019440:Anti-Obesity Agents; D003503:Cyclobutanes; D005473:Fluoxetine; D008454:Mazindol; D004053:Diethylpropion; C026013:fenproporex; C058254:sibutramine