TY - JOUR
T1 - Six-month efficacy and safety of amfepramone in obese Mexican patients
T2 - A double-blinded, randomized, controlled trial
AU - Soto-Molina, Herman
AU - Pizarro-Castellanos, Mariel
AU - Rosado-Pérez, Juana
AU - Rizzoli-Córdoba, Antonio
AU - Lara-Padilla, Eleazar
AU - Del Valle-Laisequilla, Cecilia Fernández
AU - Reyes-García, Juan Gerardo
N1 - Publisher Copyright:
© 2015 Dustri-Verlag Dr. K. Feistle.
PY - 2015/7/1
Y1 - 2015/7/1
N2 - 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.
AB - 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.
KW - Amfepramone
KW - Diethylpropion
KW - Mexican, noradrenaline-releasing drug
KW - Obesity
UR - http://www.scopus.com/inward/record.url?scp=84936765975&partnerID=8YFLogxK
U2 - 10.5414/CP202135
DO - 10.5414/CP202135
M3 - Artículo
SN - 0946-1965
VL - 53
SP - 541
EP - 549
JO - International Journal of Clinical Pharmacology and Therapeutics
JF - International Journal of Clinical Pharmacology and Therapeutics
IS - 7
ER -