Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone
- PMID: 20584880
- DOI: 10.1001/jama.2010.920
Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone
Abstract
Context: Studies have suggested that the use of rosiglitazone may be associated with an increased risk of serious cardiovascular events compared with other treatments for type 2 diabetes.
Objective: To determine if the risk of serious cardiovascular harm is increased by rosiglitazone compared with pioglitazone, the other thiazolidinedione marketed in the United States.
Design, setting, and patients: Nationwide, observational, retrospective, inception cohort of 227,571 Medicare beneficiaries aged 65 years or older (mean age, 74.4 years) who initiated treatment with rosiglitazone or pioglitazone through a Medicare Part D prescription drug plan from July 2006-June 2009 and who underwent follow-up for up to 3 years after thiazolidinedione initiation.
Main outcome measures: Individual end points of acute myocardial infarction (AMI), stroke, heart failure, and all-cause mortality (death), and composite end point of AMI, stroke, heart failure, or death, assessed using incidence rates by thiazolidinedione, attributable risk, number needed to harm, Kaplan-Meier plots of time to event, and Cox proportional hazard ratios for time to event, adjusted for potential confounding factors, with pioglitazone as reference.
Results: A total of 8667 end points were observed during the study period. The adjusted hazard ratio for rosiglitazone compared with pioglitazone was 1.06 (95% confidence interval [CI], 0.96-1.18) for AMI; 1.27 (95% CI, 1.12-1.45) for stroke; 1.25 (95% CI, 1.16-1.34) for heart failure; 1.14 (95% CI, 1.05-1.24) for death; and 1.18 (95% CI, 1.12-1.23) for the composite of AMI, stroke, heart failure, or death. The attributable risk for this composite end point was 1.68 (95% CI, 1.27-2.08) excess events per 100 person-years of treatment with rosiglitazone compared with pioglitazone. The corresponding number needed to harm was 60 (95% CI, 48-79) treated for 1 year.
Conclusion: Compared with prescription of pioglitazone, prescription of rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older.
Comment in
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Rosiglitazone and the case for safety over certainty.JAMA. 2010 Jul 28;304(4):469-71. doi: 10.1001/jama.2010.954. Epub 2010 Jun 28. JAMA. 2010. PMID: 20584879 No abstract available.
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Insulin sensitizers and heart failure: an engine flooded with fuel.Curr Hypertens Rep. 2010 Dec;12(6):399-401. doi: 10.1007/s11906-010-0158-7. Curr Hypertens Rep. 2010. PMID: 20963518 Free PMC article.
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ACP Journal Club. In older patients, rosiglitazone was associated with increased risk for stroke, heart failure, and mortality compared with pioglitazone.Ann Intern Med. 2010 Dec 21;153(12):JC6-11. doi: 10.7326/0003-4819-153-12-201012210-02011. Ann Intern Med. 2010. PMID: 21173400 No abstract available.
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