( physicians and patients immediately so ...)Interim Data From RECORD Study Show No Significant Difference,Between Avandia and Standard Therapy in Risk of Cardiovascular,Hospitalization or Death,Health

Richard Nesto, MD, Chairman of the Department of Cardiovascular Medicine at the Lahey Clinic Medical Center, said these new findings provide important information for physicians caring for diabetic patients. "Despite its limitations, the recent meta-analysis in the New England Journal of Medicine raised important questions about the cardiac safety of rosiglitazone. These questions can only be answered with better evidence from clinical trials. This interim analysis of RECORD, a randomized prospective clinical trial, helps to establish the overall cardiac safety profile of the drug," said Dr. Nesto, who is an author of the American Heart Association and American Diabetes Association consensus statement on the use of thiazolidinediones in diabetic patients with heart disease. "Additional clinical trials are underway to specifically address this issue, but the data from RECORD should be reassuring for physicians who need effective drugs to lower blood sugar levels -- the main cornerstone of treatment for diabetic patients."

The RECORD study's robust design and breadth make it uniquely suited to answer questions about cardiovascular risk with Avandia.

First, the study was designed to include a wide range of Type 2 diabetes patients, including those with and without existing cardiovascular disease, making it highly representative of real-world diabetes patients. Second, patients in RECORD were managed such that blood sugar remained within current guidelines, thereby eliminating a variable that may affect results, as inadequate blood sugar control is itself associated with cardiovascular events. Third, although an open-label design, each cardiovascular event was verified by an independent panel of physicians who did not know which medicines the patients were taking.

Under these rigorous standards, the interim analysis shows that the inci
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