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Long-term weight control study. IV (weeks 156 to 190). The second double-blind phase.
M Weintraub1, P R Sundaresan, B Schuster
1Department of Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry, NY.
Clinical Pharmacology and Therapeutics
|May 1, 1992
Summary
This 3-year study found that sustained-release fenfluramine plus phentermine significantly reduced weight regain compared to placebo. While both groups gained weight, the medication group experienced less weight gain and better appetite control.
Area of Science:
- Pharmacology
- Obesity Research
- Clinical Trials
Background:
- Long-term efficacy of anorexiant medications is crucial for sustained weight management.
- Previous studies indicated short-term benefits of fenfluramine and phentermine for weight loss.
Purpose of the Study:
- To evaluate the continued efficacy of fenfluramine plus phentermine over 3 years in a double-blind trial.
- To compare weight changes and appetite control between active medication and placebo groups.
Main Methods:
- A 30-week double-blind trial involving 52 participants continuing from a prior study.
- Comparison of 60 mg sustained-release fenfluramine plus 15 mg phentermine resin versus placebo, alongside behavioral modification, caloric restriction, and exercise.
Main Results:
- Participants on fenfluramine plus phentermine gained significantly less weight (4.4 kg) than placebo (6.9 kg) over 30 weeks (p < 0.01).
- Both groups remained below initial weights, with the medication group showing a greater deficit.
- Fenfluramine plus phentermine demonstrated better appetite control with only slightly increased adverse events.
Conclusions:
- Sustained-release fenfluramine plus phentermine offers continued efficacy in managing weight over 3 years.
- The combination therapy provides significant benefits for weight control and appetite suppression.
- No negative learning effects were observed from initial medication exposure.