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Interim Data From RECORD Study Show No Significant Difference,Between Avandia and Standard Therapy in Risk of Cardiovascular,Hospitalization or Death

"Patients and physicians should find these data reassuring"

PHILADELPHIA, June 05, 2007 /PRNewswire-FirstCall/ -- GlaxoSmithKline said today that findings from an interim analysis of RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes), a prospective clinical trial designed specifically to determine cardiovascular outcomes in more than 4,400 patients with type 2 diabetes, adds further evidence to the overall cardiovascular safety profile of Avandia(R) (rosiglitazone maleate). The study results, authored by Philip D. Home and colleagues on the RECORD Steering Committee, were published Tuesday in the online edition of The New England Journal of Medicine.

The study compares cardiovascular hospitalization and death in patients treated with Avandia dual therapy (Avandia plus metformin or sulfonylurea) and in patients treated with metformin and sulfonylurea in combination. After following patients for an average of 3.75 years, the interim analysis found a low number of events overall, and a similar number of events in each group. The study is scheduled to complete in late 2008.

Like all interim analyses, these data do not offer final conclusions. Based on the interim analysis, key findings include:

    -- The interim data show no significant difference between the Avandia and

       control groups in the key outcomes of hospitalization or death due to

       cardiovascular events.

    -- There was no difference between the groups in mortality, whether

       cardiovascular deaths or deaths from all causes.

    -- The interim data show that Avandia was not significantly different than

       the control groups in several secondary outcomes, including heart

       attack.

    -- A significant difference between the Avandia and control groups was

       seen only in the secondary outcome of congestive heart failure (CHF),

       where significantl
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