Safety and efficacy of fenproporex for obesity treatment: a systematic review
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , |
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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Revista de Saúde Pública |
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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 |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102016000100503 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102016000100503 |
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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1748936503716741120 |