A randomized double-blind placebo-controlled study of the long-term efficacy and safety of diethylpropion in the treatment of obese subjects

Abstract

Objective: To evaluate the efficacy of diethylpropion on a long-term basis, with emphasis in cardiovascular and psychiatric safety aspects. Design: Randomized, double-blind, placebo-controlled trial Measurements: Following a 2-week screening period, 69 obese healthy adults received a hypocaloric diet and were randomized to diethylpropion 50 mg BID (n ¼ 37) or placebo (n ¼ 32) for 6 months. After this period, all participants received diethylpropion in an open-label extension for an additional 6 months. The primary outcome was percentage change in body weight. Electrocardiogram (ECG), echocardiography and clinical chemistry were performed at baseline and every 6 months. Psychiatric evaluation and application of Hamilton rating scales for depression and anxiety were also performed by experienced psychiatrists at baseline and every 3 months. Results: After 6 months, the diethylpropion group lost an average of 9.8% (s.d. 6.9%) of initial body weight vs 3.2% (3.7%) in the placebo group (Po0.0001). From baseline to month 12, the mean weight loss produced by diethylpropion was 10.6% (8.3%). Participants in the placebo group who were switched to diethylpropion after 6 months lost an average of 7.0% (7.7%) of initial body weight. The difference between groups at month 12 was not significant (P ¼ 0.07). No differences in blood pressure, pulse rate, ECG and psychiatric evaluation were observed. Dry mouth and insomnia were the most frequent adverse events. Conclusion: Diethylpropion plus diet produced sustained and clinically significant weight loss over 1 year. It seems to be safe in relation to cardiovascular and psychiatric aspects in a well-selected population.

D1 and D2 antagonists reverse the effects of appetite suppressants on weight loss, food intake, locomotion, and rebalance spiking inhibition in the rat NAc shell

“…Previous studies in humans revealed that at appropriate concentrations, DEP, PHEN, and BUP produce weight loss (Hendricks et al 2009) with the order DEP Ն PHEN Ͼ BUP (Cercato et al 2009;Suplicy et al 2014). In the present study, using rats, we found that DEP20 was slightly more potent than PHEN20 with regard to weight loss (Fig.…”

“…For humans, after 5-6 mo of treatment their weight loss plateaus. From this point their body weight is either maintained or is slowly increased (Cercato et al 2009). Although the mechanisms explaining why appetite suppressants develop tolerance are largely unknown, we found that LFP oscillations in the NAc shell can be used as a biomarker to determine when tolerance to DEP20 develops.…”

Interfaces between bariatric surgery and oral health: a longitudinal survey

“…After 6 months the saliva flow returned to normal. This reduction in salivary flow in patients before surgery and newly operated patients may be associated with the treatment for diabetes in most obese patients 23 . Whereas, the use of medications for hypertension, diabetes, hyperlipidemia and antidepressants decreased significantly after only 3 months of bariatric surgery 23 .…”

Systematic Review and Meta-Analysis of The Efficacy And Safety Of Amfepramone and Mazindol As A Monotherapy for The Treatment of Obese or Overweight Patients

“…Treatment with amfepramone led to greater loss of body weight than treatment with placebo in all studies (28,30,37,38,41,44) regardless of daily dosage and treatment duration (MD =-1.291 kg (95% CI: -1.548; -1.035), heterogeneity test p=0.000; I 2 : 85.5%). After subgroup analysis of treatment duration (short-term: o180 days and long-term: 4180 days) (37).…”

“…Our review identified only two studies, of 6 and 12 months of follow up, that reported the outcome of 45% weight loss (28,41). The first identified 66.7% of patients reaching such an outcome with amfepramone treatment compared to 25% in the placebo group.…”