According to the FDA’s announcement, the “FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk in a 2007 safety alert. The agency also sought advice from external experts at the July 30, 2007, joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by FDA since the 2007 announcements.”

The RECORD study, which stands for Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes, was designed to evaluate the cardiovascular safety of rosiglitazone. This practice is consistent with the FDA’s December 2008 Guidance for Industry that recommends that manufacturers of new treatments for diabetes carefully design their clinical trials to include an evaluation of cardiovascular safety.

Once the FDA has completed its review of rosiglitazone, the agency will present its findings at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

Rosiglitazone, a treatment for Type 2 diabetes, is sold as a single-ingredient product under the brand name Avandia, and is available in combination with other diabetes medications, such as metformin, under the brand name Avandament, or glimepride, under the brand name Avandaryl. The FDA advises that patients who are currently taking any form of rosiglitazone should not stop taking their medication without first talking to their healthcare professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.

SOURCE: Avandia Recall › FDA announces it will review studies linking Avandia to heart attacks

Researchers announced the results of the RECORD trial at the American Diabetes Association meeting in New Orleans. The study monitored 2,220 patients who received Avandia (rosiglitazone) as a supplement to metformin, normally the first-line drug in diabetes 2 treatment, or sulphonylurea. 2,227 other patients received a combination of metformin and sulphonylurea without Avandia.

GlaxoSmithKline said the findings confirmed that “cardiovascular hospitalization and cardiovascular death was not statistically different between the two groups after an average of 5.5 years of therapy.”

Philip Home, a professor at Newcastle University in Newcastle Upon Tyne in the UK and chairman of the RECORD trial, said the data “leads us to conclude that rosiglitaone carries no increased risk of overall cardiovascular death or hospitalization compared to the most commonly used diabetes medicines…which have been used for decades.”

However, an editorial by Toronto doctors Ravi Retnakaran and Bernard Zimman in the medical journal The Lancet, in which the RECORD results were published, raised doubts about the study’s accuracy. The doctors wrote that “definitive conclusions about the relation between rosiglitazone and cardiovascular disease remain elusive, owing to study limitations.”

The overall rate of cardiovascular problems in the RECORD patients was unusually low, and ten percent more of the Avandia patients were taking statins – cholesterol fighting drugs that effectively reduce the risk of heart attack.

Moreover, 45 percent of the RECORD participants dropped out of the study at some point, yet Glaxo maintains that the high dropout rate did not influence the results. Doctors Retnakaran and Zimman believe that dropout rate alone compromises the trial’s conclusions.

Steven E. Nissen, M.D. of the Cleveland Clinic said that “it is impossible to assess the safety of a drug when patients are not actually taking it.”

SOURCE: Avandia Recall › Doctors and critics doubt the accuracy of Avandia study