title: Long-term weight control study. I (weeks 0 to 34). The enhancement of behavior modification, caloric restriction, and exercise by fenfluramine plus phentermine versus placebo.
abstract: To investigate the value of anorexiant medications as an adjunct to other forms of weight control therapy, we studied 121 people in a 34-week, double-blind clinical trial of 60 mg extended-release fenfluramine plus 15 mg phentermine resin versus placebo added to behavior modification, caloric restriction, and exercise. Participants weighed 130% to 180% (154% +/- 1.2%, mean +/- SEM) of ideal body weight (1983 Metropolitan Life tables) and were in good health. By week 34, participants receiving active medication lost an average of 14.2 +/- 0.9 kg, or 15.9% +/- 0.9% of initial weight (n = 58), versus a loss of 4.6 +/- 0.8 kg or 4.9% +/- 0.9% of initial weight by subjects taking placebo (n = 54; p less than 0.001). On visual analog scales, participants rated fenfluramine plus phentermine as more helpful than placebo (50.3 +/- 0.5 versus 20.3 +/- 0.3) and not bothersome (fenfluramine plus phentermine, 17.4 +/- 0.3 versus 13.5 +/- 0.2). Blood pressure decreased and pulse remained unchanged in both groups. Dry mouth was the most common adverse effect in subjects receiving fenfluramine plus phentermine; all adverse effects decreased after 4 weeks. Only nine participants left the study in the first 34 weeks. Two subjects from each group left the study as a result of adverse effects. Overall, fenfluramine plus phentermine used in conjunction with behavior modification, caloric restriction, and exercise aided weight loss and continued to be efficacious for 34 weeks.
authors.affiliation: Department of Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry, NY.
authors.forename: M
authors.initials: M
authors.lastname: Weintraub
authors.forename: P R
authors.initials: PR
authors.lastname: Sundaresan
authors.forename: M
authors.initials: M
authors.lastname: Madan
authors.forename: B
authors.initials: B
authors.lastname: Schuster
authors.forename: A
authors.initials: A
authors.lastname: Balder
authors.forename: L
authors.initials: L
authors.lastname: Lasagna
authors.forename: C
authors.initials: C
authors.lastname: Cox
mesh_terms: D000328:Adult; D001521:Behavior Therapy; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight; D004038:Diet, Reducing; D004311:Double-Blind Method; D015444:Exercise; D005247:Feeding Behavior; D005260:Female; D005277:Fenfluramine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D010645:Phentermine / Q000627:therapeutic use*; D011674:Pulse / Q000187:drug effects; D013997:Time Factors; D015431:Weight Loss
chemical_list: D005277:Fenfluramine; D010645:Phentermine