Safety and efficacy of fenproporex for obesity treatment: a systematic review

Detalhes bibliográficos
Autor(a) principal: Paumgartten,Francisco José Roma
Data de Publicação: 2016
Outros Autores: Pereira,Sabrina Schaaf Teixeira Costa, Oliveira,Ana Cecilia Amado Xavier de
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Revista de Saúde Pública
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102016000100503
Resumo: ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.
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spelling Safety and efficacy of fenproporex for obesity treatment: a systematic reviewAnti-Obesity Agents, adverse effectsAppetite Depressants, toxicityAmphetamine, contraindicationsDrug UtilizationOff-Label UseEffectivenessSafetyControlled Clinical TrialReviewABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.Faculdade de Saúde Pública da Universidade de São Paulo2016-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102016000100503Revista de Saúde Pública v.50 2016reponame:Revista de Saúde Públicainstname:Universidade de São Paulo (USP)instacron:USP10.1590/S1518-8787.2016050006208info:eu-repo/semantics/openAccessPaumgartten,Francisco José RomaPereira,Sabrina Schaaf Teixeira CostaOliveira,Ana Cecilia Amado Xavier deeng2016-05-31T00:00:00Zoai:scielo:S0034-89102016000100503Revistahttp://www.scielo.br/scielo.php?script=sci_serial&pid=0034-8910&lng=pt&nrm=isoONGhttps://old.scielo.br/oai/scielo-oai.phprevsp@org.usp.br||revsp1@usp.br1518-87870034-8910opendoar:2016-05-31T00:00Revista de Saúde Pública - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Safety and efficacy of fenproporex for obesity treatment: a systematic review
title Safety and efficacy of fenproporex for obesity treatment: a systematic review
spellingShingle Safety and efficacy of fenproporex for obesity treatment: a systematic review
Paumgartten,Francisco José Roma
Anti-Obesity Agents, adverse effects
Appetite Depressants, toxicity
Amphetamine, contraindications
Drug Utilization
Off-Label Use
Effectiveness
Safety
Controlled Clinical Trial
Review
title_short Safety and efficacy of fenproporex for obesity treatment: a systematic review
title_full Safety and efficacy of fenproporex for obesity treatment: a systematic review
title_fullStr Safety and efficacy of fenproporex for obesity treatment: a systematic review
title_full_unstemmed Safety and efficacy of fenproporex for obesity treatment: a systematic review
title_sort Safety and efficacy of fenproporex for obesity treatment: a systematic review
author Paumgartten,Francisco José Roma
author_facet Paumgartten,Francisco José Roma
Pereira,Sabrina Schaaf Teixeira Costa
Oliveira,Ana Cecilia Amado Xavier de
author_role author
author2 Pereira,Sabrina Schaaf Teixeira Costa
Oliveira,Ana Cecilia Amado Xavier de
author2_role author
author
dc.contributor.author.fl_str_mv Paumgartten,Francisco José Roma
Pereira,Sabrina Schaaf Teixeira Costa
Oliveira,Ana Cecilia Amado Xavier de
dc.subject.por.fl_str_mv Anti-Obesity Agents, adverse effects
Appetite Depressants, toxicity
Amphetamine, contraindications
Drug Utilization
Off-Label Use
Effectiveness
Safety
Controlled Clinical Trial
Review
topic Anti-Obesity Agents, adverse effects
Appetite Depressants, toxicity
Amphetamine, contraindications
Drug Utilization
Off-Label Use
Effectiveness
Safety
Controlled Clinical Trial
Review
description ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.
publishDate 2016
dc.date.none.fl_str_mv 2016-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102016000100503
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dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S1518-8787.2016050006208
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Faculdade de Saúde Pública da Universidade de São Paulo
publisher.none.fl_str_mv Faculdade de Saúde Pública da Universidade de São Paulo
dc.source.none.fl_str_mv Revista de Saúde Pública v.50 2016
reponame:Revista de Saúde Pública
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Revista de Saúde Pública
collection Revista de Saúde Pública
repository.name.fl_str_mv Revista de Saúde Pública - Universidade de São Paulo (USP)
repository.mail.fl_str_mv revsp@org.usp.br||revsp1@usp.br
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