Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.

By Steven E. Nissen, K. Wolski. New England Journal of Medicine, 2007

4,792 citations recorded by the source corpus.

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.

Subfields: Endocrinology, Diabetes and Metabolism, Molecular Biology

View Paper: https://www.semanticscholar.org/paper/238422dc26dc6a78cb2b03fad835d7d1f1f95edb

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Citations in the corpus

Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. (2008, result): “In addition, rosiglitazone has been associated with an increased risk of myocardial infarction or other ischemic events in several meta-analyses, whereas a similar metaanalysis of pioglitazone showed a reduction in the risk of adverse cardiovascular outcomes.(30,31) Furthermore, a well-controlled ra”
Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009, background): “Several meta-analyses have suggested a 30 – 40% relative increase in risk for myocardial infarction (65,66) with rosiglitazone.”
Obesity, inflammation, and atherosclerosis (2009, background): “Nevertheless, a meta-analysis that evaluated several thiazolidinedione trials suggested that treatment with rosiglitazone is associated with an increased risk of myocardial infarction and cardiovascular death”
Inflammatory Mechanisms in the Regulation of Insulin Resistance (2008, background): “Recently some caution on this drug class has been raised, as metaanalyses demonstrated an increased rate of cardiovascular events in certain patient groups (123,124).”
Mechanisms of diabetic complications. (2013, background): “The utility of thiazolidinediones has been overshadowed, however, by the increased incidence of cardiovascular events including myocardial infarction seen with the PPAR agonist rosiglitazone (426).”
Dietary carbohydrate restriction as the first approach in diabetes management: critical review and evidence base. (2015, neutral): “” The original result has been disputed [86–89] and the fate of the drug is unknown, but no such ambiguity attaches to dietary carbohydrate restriction.”
Trends in Prescription Drug Use among Adults in the United States from 1999–2012 (2015, neutral): “(%) [95% CI]b Any Prescriptions Polypharmacy (≥5 Prescriptions) Overall 5558 3144 (59) [55-62] 917 (15) [13-17] Age group, y 20-39 1957 596 (35) [32-39] 47 (3.”
Systematic Review: Comparative Effectiveness and Safety of Oral Medications for Type 2 Diabetes Mellitus (2007, result): “Nissen and Wolski (11) recently reported results of a meta-analysis suggesting a relationship between use of rosiglitazone and risk for myocardial infarction.”
Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials (2011, background): “Rosiglitazone was recently withdrawn from the European market and restricted for use by the US Food and Drug Administration for safety reasons.”
Atherosclerotic Cardiovascular Disease and Heart Failure in Type 2 Diabetes – Mechanisms, Management, and Clinical Considerations (2016, neutral): “FDA concerns regarding diabetes mellitus drug development were furthered in part by a meta-analysis of several small trials suggesting excess risk with the drug rosiglitazone.(369) Notably the Rosiglitazone Evaluated for Cardiovascular Outcomes in oral agent combination therapy for type 2 Diabetes (”