40952
document
A randomized double-blind placebo-controlled study of the long-term efficacy and safety of diethylpropion in the treatment of obese subjects . 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=37 ) or placebo ( n=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 ( P < 0.0001 ) . 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=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 .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
diethylpropion
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Intervention_Pharmacological
diethylpropion
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Intervention_Pharmacological
hypocaloric diet
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Intervention_Pharmacological
diethylpropion 50 mg BID
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Intervention_Control
placebo
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Intervention_Pharmacological
diethylpropion
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Intervention_Control
placebo
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Intervention_Control
placebo
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Intervention_Pharmacological
diethylpropion
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Intervention_Pharmacological
Diethylpropion
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Outcome_Physical
percentage change in body weight . Electrocardiogram ( ECG ) , echocardiography and clinical chemistry
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Outcome_Mental
Psychiatric evaluation and application of Hamilton rating scales for depression and anxiety
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Outcome_Physical
body weight
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Outcome_Physical
mean weight loss
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Outcome_Physical
initial body weight
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Outcome_Physical
blood pressure , pulse rate , ECG
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Outcome_Physical
psychiatric evaluation
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Outcome_Adverse-effects
Dry mouth and insomnia
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Participant_Condition
obese
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Participant_Sample-size
69 obese healthy adults
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Participant_Condition
hypocaloric diet