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Cited by 594

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Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality

Nissen, Steven E., Wolski, Kathy·2010·Archives of Internal Medicine

Abstract

CONTEXT: Controversy regarding the effects of rosiglitazone therapy on myocardial infarction (MI) and cardiovascular (CV) mortality persists 3 years after a meta-analysis initially raised concerns about the use of this drug. OBJECTIVE: To systematically review the effects of rosiglitazone therapy on MI and mortality (CV and all-cause). DATA SOURCES: We searched MEDLINE, the Web site of the Food and Drug Administration, and the GlaxoSmithKline clinical trials registry for trials published through February 2010. STUDY SELECTION: The study included all randomized controlled trials of rosiglitazone at least 24 weeks in duration that reported CV adverse events. DATA EXTRACTION: Odds ratios (ORs) for MI and mortality were estimated using a fixed-effects meta-analysis of 56 trials, which included 35 531 patients: 19 509 who received rosiglitazone and 16 022 who received control therapy. RESULTS: Rosiglitazone therapy significantly increased the risk of MI (OR, 1.28; 95% confidence interval [CI], 1.02-1.63; P = .04) but not CV mortality (OR, 1.03; 95% CI, 0.78-1.36; P = .86). Exclusion of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial yielded similar results but with more elevated estimates of the OR for MI (OR, 1.39; 95% CI, 1.02-1.89; P = .04) and CV mortality (OR, 1.46; 95% CI, 0.92-2.33; P = .11). An alternative analysis pooling trials according to allocation ratios allowed inclusion of studies with no events, yielding similar results for MI (OR, 1.28; 95% CI, 1.01-1.62; P = .04) and CV mortality (OR 0.99; 95% CI, 0.75-1.32; P = .96). CONCLUSIONS: Eleven years after the introduction of rosiglitazone, the totality of randomized clinical trials continue to demonstrate increased risk for MI although not for CV or all-cause mortality. The current findings suggest an unfavorable benefit to risk ratio for rosiglitazone.

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Metadata

Authors
Nissen, S. E., & Wolski, K.
Venue
Archives of Internal Medicine
Published
2010-06-28
Volume
170
Issue
14
Pages
1191-1201
ISSN
0003-9926 (ISSN-L)
OpenAlex
W2120822075
Cited by
594
References
26
FWCI
61.21
Type
journal article
Language
en
Open access
closed

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Nissen, S. E., & Wolski, K. (2010). Rosiglitazone Revisited: An Updated Meta-analysis of Risk for Myocardial Infarction and Cardiovascular Mortality. Archives of Internal Medicine. https://doi.org/10.1001/archinternmed.2010.207

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