title: Six-month efficacy and safety of amfepramone in obese Mexican patients: a double-blinded, randomized, controlled trial.
abstract: Amfepramone, also known as diethylpropion, is an anorectic drug used for the short-term treatment of obesity; however, its efficacy and safety during periods greater than 3 months has been scarcely studied. To evaluate the 6-month efficacy and safety of amfepramone treatment in obese adult Mexican patients resistant to diet and exercise, a double-blinded, randomized, and placebo-controlled clinical trial study was designed on 156 volunteers with a body mass index (BMI) greater than 30 kg/m2 and less than 45 kg/m2. Patients were randomized to receive a 75 mg tablet of amfepramone or placebo daily for 6 months. Primary outcome was the absolute body weight loss, whereas secondary outcomes were the percentage of patients who achieved at least 5% or 10% weight loss, as well as the improvement of anthropometric and metabolic parameters. Amfepramone treatment produced a superior efficacy to decrease body weight than placebo at 3 months (-4.9±0.25 kg vs. -0.7±0.32 kg) and 6 months (-7.7±0.52 kg vs. -1.1±0.7 kg). In addition, 64 and 34 patients achieved at least 5% or 10% weight loss, respectively, with amfepramone at 6 months, compared with 8 and 0 patients on placebo. Amfepramone also significantly improved BMI and waist circumference, but it only showed a favorable tendency in the waist-hip index (WHI), glucose, total cholesterol, low-density lipoproteins (LDL), high-density lipoproteins (HDL), triglycerides, heart rate, systolic blood pressure, and diastolic blood pressure at 3 and 6 months. Amfepramone produced only mild adverse events, and they were presented in a greater number than placebo only at 3 months, dry mouth being the the main adverse event. Data suggest that amfepramone is effective and well tolerated in obese Mexican patients during a 6-month regimen.
authors.forename: Herman
authors.initials: H
authors.lastname: Soto-Molina
authors.forename: Mariel
authors.initials: M
authors.lastname: Pizarro-Castellanos
authors.forename: Juana
authors.initials: J
authors.lastname: Rosado-Pérez
authors.forename: Antonio
authors.initials: A
authors.lastname: Rizzoli-Córdoba
authors.forename: Eleazar
authors.initials: E
authors.lastname: Lara-Padilla
authors.forename: Cecilia Fernández
authors.initials: CF
authors.lastname: del Valle-Laisequilla
authors.forename: Juan Gerardo
authors.initials: JG
authors.lastname: Reyes-García
mesh_terms: D000328:Adult; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D004053:Diethylpropion / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008800:Mexico / Q000453:epidemiology; D009765:Obesity / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D055105:Waist Circumference; D049629:Waist-Hip Ratio; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D001067:Appetite Depressants; D015415:Biomarkers; D001786:Blood Glucose; D008055:Lipids; D004053:Diethylpropion