Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007; 356.
A recent meta-analysis of rosiglitazone (Avandia) indicated a significant increase in the risk of myocardial infarction and a risk of death from cardiovascular causes that had borderline significance. The authors conducted a literature search, and used the FDA Web site and a clinical-trials registry maintained by the drug manufacturer. Criteria for inclusion in the meta-analysis were: a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability outcome data for myocardial infarction and death from cardiovascular causes. The authors acknowledge that the study had limitations, including a lack of access to original source data, which would have enabled time-to-event analysis.
GlaxoSmithKline, manufacturer of the drug, defended rosiglitazone in a letter to The Lancet, citing data that suggests the actual number of heart attacks is only 0.6% for both the rosiglitazone group and the control group. The company says that overall, the heart attack safety profile is similar to two other widely used generic diabetes medicines.