Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo

Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo

Context: Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes. Objective: To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarcti...

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Autores principales: Cruz U,Ricardo, Letelier S,Luz María
Lenguaje:Spanish / Castilian
Publicado: Sociedad Médica de Santiago 2009
Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009000700019
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spelling oai:scielo:S0034-988720090007000192010-04-29Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazoCruz U,RicardoLetelier S,Luz MaríaContext: Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes. Objective: To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality. Data sources: We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007. Study selection: Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12 months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events. Data extraction: Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n =14.291, including 6.421 receiving rosiglitazone and 7.870 receiving control therapy with a duration of follow-up of 1-4 years). Results: Rosiglitazone significantly increased the risk of myocardial infarction (n =94/6421 vs. 83/7870; RR, 1.42; 95% confidence interval fCIJ, 1.06-1.91; P =.02) and heart failure (n =102/6.421 vs. 62/7.870; RR, 2.09; 95% CI, 1.52-2.88; P k.001) without a significant increase in risk of cardiovascular mortality (n =59/6.421 vs. 72/7.870; RR, 0.90; 95% CI, 0.63-1.26; P =.53). There was no evidence of substantial heterogeneity among the trials for these end points (1(2) =0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascular mortality). Conclusion: Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.137 n.7 20092009-07-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009000700019es10.4067/S0034-98872009000700019
institution Scielo Chile
collection Scielo Chile
language Spanish / Castilian
description Context: Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes. Objective: To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality. Data sources: We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007. Study selection: Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12 months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events. Data extraction: Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n =14.291, including 6.421 receiving rosiglitazone and 7.870 receiving control therapy with a duration of follow-up of 1-4 years). Results: Rosiglitazone significantly increased the risk of myocardial infarction (n =94/6421 vs. 83/7870; RR, 1.42; 95% confidence interval fCIJ, 1.06-1.91; P =.02) and heart failure (n =102/6.421 vs. 62/7.870; RR, 2.09; 95% CI, 1.52-2.88; P k.001) without a significant increase in risk of cardiovascular mortality (n =59/6.421 vs. 72/7.870; RR, 0.90; 95% CI, 0.63-1.26; P =.53). There was no evidence of substantial heterogeneity among the trials for these end points (1(2) =0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascular mortality). Conclusion: Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.
author Cruz U,Ricardo
Letelier S,Luz María
spellingShingle Cruz U,Ricardo
Letelier S,Luz María
Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo
author_facet Cruz U,Ricardo
Letelier S,Luz María
author_sort Cruz U,Ricardo
title Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo
title_short Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo
title_full Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo
title_fullStr Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo
title_full_unstemmed Análisis crítico de un artículo: La rosiglitazona aumenta los eventos cardiovasculares a largo plazo
title_sort análisis crítico de un artículo: la rosiglitazona aumenta los eventos cardiovasculares a largo plazo
publisher Sociedad Médica de Santiago
publishDate 2009
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009000700019
work_keys_str_mv AT cruzuricardo analisiscriticodeunarticulolarosiglitazonaaumentaloseventoscardiovascularesalargoplazo
AT leteliersluzmaria analisiscriticodeunarticulolarosiglitazonaaumentaloseventoscardiovascularesalargoplazo
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