Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
Open accessAbstract
BACKGROUND: Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus, but its effect on cardiovascular morbidity and mortality has not been determined. METHODS: We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. Of 116 potentially relevant studies, 42 trials met the inclusion criteria. We tabulated all occurrences of myocardial infarction and death from cardiovascular causes. RESULTS: Data were combined by means of a fixed-effects model. In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06). CONCLUSIONS: Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.
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Although the analysis is secondary, reanalyses of clinical trial data have led to the detection of adverse events well after the market entry of major drugs such as rofecoxib and rosiglitazone.
“Although our analysis is secondary, reanalyses of clinical trial data have led to the detection of adverse events well after the market entry of major drugs such as rofecoxib and rosiglitazone. [36,37]”
From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [37]
The Food and Drug Administration has restricted the use of rosiglitazone therapy to patients in whom glycemic control cannot be achieved with other medications and who cannot take pioglitazone.
“In one study, 9 the use of rosiglitazone decreased the risk of diabetes in adults with impaired glucose tolerance by 62%; given concerns about cardiovascular safety, 14 however, the Food and Drug Administration has restricted the use of rosig litazone therapy to patients in whom glycemic control cannot be achieved with other medications and who cannot take pioglitazone.”
From Pioglitazone for Diabetes Prevention in Impaired Glucose Tolerance (2011) · cites this paper as [14]
The Results report increased odds of myocardial infarction with rosiglitazone, supporting the cardiovascular-safety concern immediately preceding citation 14. But the supplied claim concerns an FDA restriction: the Discussion describes FDA approval criteria, not a restriction limiting rosiglitazone to patients who cannot use other medications or pioglitazone. Searches for those eligibility conditions found no supporting passage in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredA meta-analysis of small phase 3 trials suggested that rosiglitazone increased myocardial ischemic events (odds ratio, 1.43 [95% CI, 1.03-1.98]).
“a well-publicized meta-analysis of small phase 3 trials suggesting an increase in myocardial ischemic events (odds ratio, 1.43 [95% CI, 1.03–1.98])”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [210]
Several meta-analyses have suggested a 30-40% relative increase in risk for myocardial infarction with rosiglitazone.
“Several meta-analyses have suggested a 30–40% relative increase in risk for myocardial infarction (65,66) with rosiglitazone.”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [65]
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- Authors
- Nissen, S. E., & Wolski, K.
- Affiliations
- Cleveland Clinic (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2007-06-14
- Volume
- 356
- Issue
- 24
- Pages
- 2457-2471
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2127125241
- Semantic Scholar
- 238422dc26dc6a78cb2b03fad835d7d1f1f95edb
- Cited by
- 4,675
- References
- 29
- Citations by year
- 2026: 62 · 2025: 66 · 2024: 89 · 2023: 117 · 2022: 132 · 2021: 169 · 2020: 175 · 2019: 198 · 2018: 213 · 2017: 222 · 2016: 234 · 2015: 218 · 2014: 259 · 2013: 271 · 2012: 295
- FWCI
- 395.82
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- Locations
- New England Journal of Medicine (publishedVersion, public-domain)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Keywords
- rosiglitazone, myocardial infarction, cardiovascular mortality, type 2 diabetes, thiazolidinediones, drug safety, HbA1c
- MeSH terms
- Rosiglitazone, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Middle Aged, Myocardial Infarction, Odds Ratio, Randomized Controlled Trials as Topic, Risk Assessment, Thiazolidinediones
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