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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.
Clinics (Sao Paulo). 2017 May; 72(5):317-324.C

Abstract

The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term (<180 days; mean difference (MD) -1.281 kg; p<0.05; I2: 0.0%; p=0.379) and long-term (≥180 days; MD -6.518 kg; p<0.05; I2: 0.0%; p=0.719). Only studies with long-term follow up reported efficacy in terms of abdominal circumference and 5-10% weight reduction. These results corroborated the finding that the efficacy of amfepramone is greater than that of placebo. Treatment with mazindol showed greater short-term weight loss than that with placebo (MD -1.721 kg; p<0.05; I2: 0.9%; p=0.388). However, metabolic outcomes were poorly described, preventing a meta-analysis. A mixed treatment comparison corroborated the direct meta-analysis. Considering the high level of risk of bias and the absence of important published outcomes for anti-obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status.

Authors+Show Affiliations

Laboratório de Serviços Clínicos e Evidências em Saúde, Departamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, BR.Laboratório de Serviços Clínicos e Evidências em Saúde, Departamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, BR.Laboratório de Serviços Clínicos e Evidências em Saúde, Departamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, BR.Serviço de Endocrinologia e Metabolismo, Hospital de Clínicas, Universidade Federal do Paraná (UFPR), Curitiba, PR, BR.Departamento de Ciências Farmacêuticas, Universidade Estadual de Ponta Grossa, Ponta Grossa, PR, BR.Research Institute for Medicines (iMed.ULisboa), Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.Laboratório de Serviços Clínicos e Evidências em Saúde, Departamento de Farmácia, Universidade Federal do Paraná (UFPR), Curitiba, PR, BR.

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

28591345

Citation

Lucchetta, Rosa Camila, et al. "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." Clinics (Sao Paulo, Brazil), vol. 72, no. 5, 2017, pp. 317-324.
Lucchetta RC, Riveros BS, Pontarolo R, et al. 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. Clinics (Sao Paulo). 2017;72(5):317-324.
Lucchetta, R. C., Riveros, B. S., Pontarolo, R., Radominski, R. B., Otuki, M. F., Fernandez-Llimos, F., & Correr, C. J. (2017). 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. Clinics (Sao Paulo, Brazil), 72(5), 317-324. https://doi.org/10.6061/clinics/2017(05)10
Lucchetta RC, et al. 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. Clinics (Sao Paulo). 2017;72(5):317-324. PubMed PMID: 28591345.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Lucchetta,Rosa Camila, AU - Riveros,Bruno Salgado, AU - Pontarolo,Roberto, AU - Radominski,Rosana Bento, AU - Otuki,Michel Fleith, AU - Fernandez-Llimos,Fernando, AU - Correr,Cassyano Januário, PY - 2016/11/11/received PY - 2017/02/14/accepted PY - 2017/6/8/entrez PY - 2017/6/8/pubmed PY - 2017/9/26/medline SP - 317 EP - 324 JF - Clinics (Sao Paulo, Brazil) JO - Clinics (Sao Paulo) VL - 72 IS - 5 N2 - The aim of this study was to evaluate efficacy and safety of amfepramone, fenproporex and mazindol as a monotherapy for the treatment of obese or overweight patients. A systematic review of primary studies was conducted, followed by a direct meta-analysis (random effect) and mixed treatment comparison. Medline and other databases were searched. Heterogeneity was explored through I2 associated with a p-value. Of 739 identified publications, 25 were included in the meta-analysis. The global evaluation of Cochrane resulted in 19 studies with a high level of bias and six with unclear risk. Due to the lack of information in primary studies, direct meta-analyses were conducted only for amfepramone and mazindol. Compared to placebo, amfepramone resulted in higher weight loss in the short-term (<180 days; mean difference (MD) -1.281 kg; p<0.05; I2: 0.0%; p=0.379) and long-term (≥180 days; MD -6.518 kg; p<0.05; I2: 0.0%; p=0.719). Only studies with long-term follow up reported efficacy in terms of abdominal circumference and 5-10% weight reduction. These results corroborated the finding that the efficacy of amfepramone is greater than that of placebo. Treatment with mazindol showed greater short-term weight loss than that with placebo (MD -1.721 kg; p<0.05; I2: 0.9%; p=0.388). However, metabolic outcomes were poorly described, preventing a meta-analysis. A mixed treatment comparison corroborated the direct meta-analysis. Considering the high level of risk of bias and the absence of important published outcomes for anti-obesity therapy assessments, this study found that the evaluated drugs showed poor evidence of efficacy in the treatment of overweight and obese patients. Robust safety data were not identified to suggest changes in their regulatory status. SN - 1980-5322 UR - https://www.unboundmedicine.com/medline/citation/28591345/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_ L2 - http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S1807-59322017000500317&amp;lng=en&amp;nrm=iso&amp;tlng=en DB - PRIME DP - Unbound Medicine ER -