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Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis.

Abstract

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 6421 receiving rosiglitazone and 7870 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 [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09; 95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; 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 (I(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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. sosingh@wfubmc.edu

    ,

    Source

    JAMA 298:10 2007 Sep 12 pg 1189-95

    MeSH

    Cardiac Output, Low
    Cardiovascular Diseases
    Diabetes Mellitus, Type 2
    Humans
    Hypoglycemic Agents
    Myocardial Infarction
    Randomized Controlled Trials as Topic
    Risk
    Rosiglitazone
    Thiazolidinediones

    Pub Type(s)

    Journal Article
    Meta-Analysis

    Language

    eng

    PubMed ID

    17848653

    Citation

    Singh, Sonal, et al. "Long-term Risk of Cardiovascular Events With Rosiglitazone: a Meta-analysis." JAMA, vol. 298, no. 10, 2007, pp. 1189-95.
    Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007;298(10):1189-95.
    Singh, S., Loke, Y. K., & Furberg, C. D. (2007). Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA, 298(10), pp. 1189-95.
    Singh S, Loke YK, Furberg CD. Long-term Risk of Cardiovascular Events With Rosiglitazone: a Meta-analysis. JAMA. 2007 Sep 12;298(10):1189-95. PubMed PMID: 17848653.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. AU - Singh,Sonal, AU - Loke,Yoon K, AU - Furberg,Curt D, PY - 2007/9/13/pubmed PY - 2007/9/15/medline PY - 2007/9/13/entrez SP - 1189 EP - 95 JF - JAMA JO - JAMA VL - 298 IS - 10 N2 - 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 6421 receiving rosiglitazone and 7870 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 [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09; 95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; 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 (I(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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/17848653/full_citation L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.298.10.1189 DB - PRIME DP - Unbound Medicine ER -