CardioExchange Archive

Two new studies looking at rosiglitazone seem likely to increase pressure on the drug prior to the July FDA advisory panel that will be making recommendations about its future.

In the first study, published online in JAMA, the FDA’s David Graham, along with colleagues from Acumen and CMS, analyzed data from 227,571 Medicare beneficiaries taking either rosiglitazone or pioglitazone. The group did not find any difference between the drugs in the rate of MI, but did find a 1.25-fold increased risk of heart failure, a 1.27-fold increased risk of stroke, and a 1.14-fold increased risk of death for rosiglitazone when compared with pioglitazone.

In an accompanying editorial, David Juurlink concluded that “the epilogue of the rosiglitazone story has yet to be written, but a few observations can now be made with confidence. First, there is no direct evidence that rosiglitazone prevents vascular events in patients with diabetes. Second, converging lines of evidence suggest that rosiglitazone is less safe than pioglitazone, whereas no data suggest that the converse might be true. Third, because the evidence to date is not conclusive, differing views have emerged on how to proceed in the face of uncertainty. … Whether rosiglitazone and pioglitazone really do have different cardiovascular safety profiles is an intriguing question but one with a misplaced focus. Accumulating concerns about rosiglitazone make it difficult to advance a cogent argument why, exactly, a patient might want to receive the drug or why a physician would choose to prescribe it when there is an available and quite possibly safer alternative.”

In the second study, published online in Archives of Internal Medicine, Steve Nissen and Kathy Wolski update their famous 2007 meta-analysis that first ignited the rosiglitazone controversy. In the new analysis, the authors analyzed 56 trials involving 35,531patients, 19,509 of whom received rosiglitazone and 16,022 who received other medications, and found a significant 28-39% increased risk of myocardial infarction associated with the use of rosiglitazone. There was no increase in the risk of cardiovascular death, however.

Nissen and Wolski conclude that “because no unique benefits of rosiglitazone use have been identified, administration of this agent solely to lower blood glucose levels is difficult to justify.”