title: Weight loss produced by tesofensine in patients with Parkinson's or Alzheimer's disease.
abstract: OBJECTIVE
  Tesofensine (TE) is a norepinephrine, dopamine, and serotonin reuptake inhibitor. We conducted a meta-analysis of TE's effect on body weight in trials investigating its potential for treatment of Parkinson's or Alzheimer's disease.
  
  
  METHODS
  Four randomized, double-blind, multicenter trials compared TE (n = 740) and placebo (n = 228), two in each disease. Patients received oral TE or placebo once daily for 14 weeks without any weight loss program. Results were adjusted for baseline values, age, and study.
  
  
  RESULTS
  In the placebo group, 14% were obese and 21% were in the TE group. In the total cohort, weight change after 14 weeks was +0.5, -0.5, -0.9, -1.8, -2.8% in the placebo, 0.125, 0.25, 0.5 and 1.0 mg in the TE groups, respectively (P = 0.015 for dose effect). In the obese subgroup, weight changes were -0.2, -1.7, -1.6, -1.5, -3.7%, and 2.1, 8.2, 14.1, 20.9, 32.1% of the obese patients achieved > or = 5% weight loss (P < 0.001 for 0.25, 0.5, and 1.0 mg vs. placebo for both end points). Changes in heart rate were -0.4, 2.1, 4.2, 6.0, and 6.8 bpm after 14 weeks (TE vs. placebo: P < 0.001 from 0.25 mg), but no effect on blood pressure was observed.
  
  
  CONCLUSIONS
  TE produced a placebo-subtracted weight loss of approximately 4% for >14 weeks without any diet and lifestyle therapy, which is similar to that of sibutramine, but with no effect on blood pressure. On the basis of these results, TE is now being developed for obesity management.
authors: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Frederiksberg, Denmark. ast@life.ku.dk
authors: Arne
authors: A
authors: Astrup
authors: Dieter H
authors: DH
authors: Meier
authors: Birgit O
authors: BO
authors: Mikkelsen
authors: John S
authors: JS
authors: Villumsen
authors: Thomas M
authors: TM
authors: Larsen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy / Q000503:physiopathology*; D015306:Biogenic Monoamines / Q000037:antagonists & inhibitors*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009765:Obesity / Q000188:drug therapy / Q000503:physiopathology; D010300:Parkinson Disease / Q000188:drug therapy / Q000503:physiopathology*; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D015431:Weight Loss / Q000187:drug effects* / Q000502:physiology*
chemical_list: D015306:Biogenic Monoamines; D019086:Bridged Bicyclo Compounds, Heterocyclic; D017367:Selective Serotonin Reuptake Inhibitors; C518479:Tesofensine