In response to the growing controversy, investigators for the clinical trial known as RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes), which aims to evaluate the cardiac safety of Avandia, have conducted a highly unusual and unplanned evaluation of the ongoing study's interim results. These interim results were published on-line in the New England Journal of Medicine on June 5. The purpose of this report, apparently, is to allay the widespread concern that has arisen regarding Avandia over the past two weeks. The RECORD investigators point out that the results, so far, have failed to show a significant increase in heart attacks in patients randomized to Avandia, and indeed that there have actually been fewer deaths in Avandia patients than in control subjects.
Editorialists responding to this interim analysis in three separate articles in the same edition of the Journal, however, are having none of that. They point out that the statistical power of such an interim analysis is weak. Further, they point out that while it is true that fewer patients in the RECORD trial have died so far on Avandia than on control therapy (29 vs. 35), more patients on Avandia have had heart attacks (43 vs. 37), and more have experienced the planned study endpoint of hospitalization or death from cardiac causes (217 vs. 202).
Overall, the interim analysis of the RECORD trial neither exonerates nor convicts Avandia definitively. Patients and their doctors are left in much the same position as before - deciding today whether any potential benefits imparted by Avandia (in comparison to other available treatments for diabetes), are worth the risk that the drug may eventually be proven to increase heart attacks and cardiac death.
