Editor's Note: This study was funded by the Office of the Assistant Secretary for Planning and Evaluation (ASPE), the Centers for Medicare & Medicaid Services (CMS), and the U.S. Food and Drug Administration (FDA). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Rosiglitazone and the Case for Safety Over CertaintyIn an accompanying editorial, David Juurlink, M.D., Ph.D., of the Sunnybrook Research Institute; the Departments of Medicine, Pediatrics and Health Policy, Management, and Evaluation at the University of Toronto; and the Institute for Clinical Evaluative Sciences, Toronto, highlights the importance of the findings of the report by Graham and colleagues in terms of understanding the risks of rosiglitazone.

Dr. Juurlink writes, "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."

Source JAMA