2007, Number 1
Rev Mex Cardiol 2007; 18 (1)
Effectiveness and safety of amphepramone in a slow release as part of the integral management of obesity
Raúl Morín Zaragoza; Sergio Lonngi Villanueva; Ponce López, María Luisa; Rossana Alcaraz Ortíz; Luis Antonio Barragán Díaz Infante
ABSTRACTBackground: Amphepramone (diethylpropion) is one of the first synthetic anorexigenics developed, however recent studies following current experimental designs for these drugs are required. In addition, slow release formulations has shown advantages, mainly from the safety point of view, therefore slow release formulations of anorexigenics has been developed. Objective: Evaluate the effectiveness, but mainly the safety of amphepramone in a slow release formulation as part of the integral management of obesity. Patients and procedure: Sixty obese (BMI ≥ 30) adult patients were treated during six months plus one withdrawal month. Participants were randomly assigned to one of two groups: placebo (P) or slow release amphepramone 75 mg/day (LLANF). Hypocaloric diet and a 30 minutes walk five days per week were also indicated. Medical history was done at day 0 and at 30 days intervals. Laboratory tests were performed on days 0, 90, 180 y 210. A difference of p ‹ 0.05 was considered as statistically significant. Results: Both groups lose weigh and reduce their BMI. However, these changes were earlier and more pronounced in the LLANF group. Reduction was observed mainly in body fat and was associated with waist circumference reduction. With the intention to treat analysis, the weigh lost at 180 days was 5.0 ± 4.8 kg (5.3%) and a waist reduction of 6.3 cm in the P group and 9.2 ± 4.8 kg (10.3%) and 10.4 cm of waist with LLANF (p ‹ 0.05 vs basal in both groups). Non-statistical but clinically significative reduction of LDL–c and triglycerides were observed. Adverse events were mild, occurred mainly in the first three months of therapy and do not required withdrawal. Also, no deleterious laboratory changes were detected. Conclusion: These results confirm the effectiveness and safety of the amphepramone slow release formulation amid in the integral management of obese patients. Because their profile and background, amphepramone should be study in obese comorbid patients, mainly those with cardiovascular disease.