A placebo-controlled, dose-response study of dexfenfluramine in the treatment of obese patients
| Autor: | Thomas C. Marbury, Danny H. Sugimoto, R. Michael Gulley, Arthur Krosnick, John E. Angelo, Stephen R. Zellner |
|---|---|
| Rok vydání: | 1996 |
| Předmět: |
Pharmacology
medicine.medical_specialty Randomization business.industry Dexfenfluramine Placebo chemistry.chemical_compound Endocrinology chemistry Oral administration Norfenfluramine Weight loss Internal medicine Anesthesia medicine Anorectic Pharmacology (medical) medicine.symptom Adverse effect business medicine.drug |
| Zdroj: | Current Therapeutic Research. 57:663-674 |
| ISSN: | 0011-393X |
| DOI: | 10.1016/s0011-393x(96)80071-3 |
| Popis: | A randomized, placebo-controlled, multicenter, parallel-group study was performed to determine which of three dose levels of dexfenfluramine (Dfen)—10, 30, or 60 mg/d—in combination with a sex- and body weight—specific reduction in caloric intake best reduced body weight and produced the fewest adverse events over a 12-week period. Three hundred thirty-nine patients whose body weight was 120% to 180% of ideal body weight were randomized to one of four treatment groups: placebo, Dfen 10 mg/d, Dfen 30 mg/d, or Dfen 60 mg/d. Patients were treated in a double-masked fashion for 12 weeks and were monitored during a 4-week posttreatment period. Data from 322 patients (placebo, 82 patients; Dfen 10 mg, 84 patients; Dfen 30 mg, 79 patients; Dfen 60 mg, 77 patients) were available for efficacy analysis. After 12 weeks, a statistically significant weight loss was observed in the 30-mg and 60-mg Dfen treatment groups but not in the 10-mg Dfen group, when compared with placebo. Mean absolute weight losses were 2.83 kg (placebo), 2.79 kg (Dfen 10 mg), 5.63 kg (Dfen 30 mg), and 7.23 kg (Dfen 60 mg). All treatment groups showed a tendency to regain weight during the posttreatment period, but the Dfen 30-mg and 60-mg groups still ranked highest for overall weight loss at the end of this period. The frequency of diarrhea, asthenia, dizziness, dry mouth, and somnolence increased with increasing doses of Dfen. Blood pressure slightly decreased with higher doses of Dfen but returned toward normal after treatment ceased. Plasma concentrations of Dfen increased with increasing doses; no tendency for accumulation of Dfen or d -norfenfluramine was observed. The results of this study show that 12 weeks of treatment with Dfen was effective in reducing weight in a dose-dependent manner; based on the efficacy analysis and side-effect profile, the dose of 30 mg/d was found to be optimal. |
| Databáze: | OpenAIRE |
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