( y more cases were seen in Avandia patie...)Interim Data From RECORD Study Show No Significant Difference,Between Avandia and Standard Therapy in Risk of Cardiovascular,Hospitalization or Death,Health

y more cases were seen in Avandia patients - consistent with the well known association between fluid retention and TZDs, the class of medicine to which Avandia belongs. Fluid retention can worsen or lead to CHF. Importantly, despite the increase in CHF, there was no difference between the Avandia group and the control groups in the key outcome of cardiovascular hospitalizations and death.

"The interim findings do not show evidence of a significant difference in cardiovascular death and heart attack between Avandia and the control groups, and therefore do not confirm the hypothesis generated by the recently published meta-analysis in the New England Journal of Medicine that raised concerns about these events with Avandia," said Moncef Slaoui, chairman, R&D for GSK. "They add to the weight of evidence, from both previously published long-term clinical trials and other studies, that the overall ischemic cardiovascular safety profile of Avandia is comparable to the traditional anti-diabetes treatments. Patients and physicians should find these data reassuring."

Because Avandia has been shown to control blood sugar for longer than other traditional oral anti-diabetic medicines, it is an important option for physicians who often need to prescribe a combination of diabetes medicines to help their patients maintain blood sugar levels.

Professor Home, Vice President, International Diabetes Federation, University of Newcastle-upon-Tyne, UK, and chairman of the RECORD Steering Committee, said that although the study is not expected to be complete until late 2008, the committee concluded that an interim analysis should be published as soon as possible. "Ideally, we would have allowed RECORD to complete before analyzing and releasing the results," Home said. "However, in light of the questions raised recently about Avandia, we felt it critical that interim data from this important study be made available to
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