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

International Journal of Obesity volume 33, pages 857–865 (2009)Cite this article

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=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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Acknowledgements

We are grateful to Dr Michele Leao França for assistance with patients at the beginning of the study. We thank Dr Enrico Repetto for excellent technical assistance. We acknowledge the Medley Pharmaceutical for providing the placebo and diethylpropion treatment.

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Authors and Affiliations

  1. Endocrinology and Metabolism Department, Obesity and Metabolic Syndrome Group, Hospital das Clínicas, University of São Paulo-Brazil, São Paulo, Brazil

    C Cercato, V A Roizenblatt, C C Leança, A Segal, A P Lopes Filho, M C Mancini & A Halpern

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  1. C Cercato
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Correspondence to C Cercato.

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Cercato, C., Roizenblatt, V., Leança, C. et al. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of diethylpropion in the treatment of obese subjects. Int J Obes 33, 857–865 (2009). https://doi.org/10.1038/ijo.2009.124

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