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 < 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.
|Original language||English (US)|
|Number of pages||9|
|Journal||Clinical pharmacology and therapeutics|
|State||Published - 1992|
ASJC Scopus subject areas
- Pharmacology (medical)