Rosiglitazone advice (1):
- the European Committee on Medicinal Products for Human Use has recommended the suspension of the marketing authorisations of the medicine across the European Union
- the UK Commission on Human Medicines (CHM) has reviewed the available data and has concluded that there is an increased cardiovascular risk for rosiglitazone. It has not been possible to identify additional measures that would reduce the cardiovascular risk or to identify a patient population in whom the benefits continue to outweigh the risks
- CHM has therefore concluded that the benefits of rosiglitazone no longer outweigh its risks
A meta-analysis was undertaken to assess the cardiovascular risk associated with use of rosiglitazone in patients with type 2 diabetes (2)
- a search of published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline) was undertaken
- 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
- 42 trials met the inclusion criteria
- the study authors tabulated all occurrences of myocardial infarction and death from cardiovascular causes
- study results
- 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)
- the authors concluded that:
- 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
- authors noted that their 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..."
Note also that glitazone therapy is associated with an increased heart failure risk:
- study evidence suggests that about 1 in every 50 patients taking a glitazone for 26 months would experience heart failure compared with those taking placebo or another oral antidiabetic agent (3)
- a systematic review concluded that (4) 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
However note that the US Food and Drug Administration announced (5):
- The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on our review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute
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