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GlaxoSmithKline Responds to US Senate Committee on Finance Report on Avandia
Date:2/24/2010

RECORD provides the best, most reliable assessment of Avandia's cardiovascular safety. RECORD was initiated in 2001 and, in consultation with European regulators, was designed to compare cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea.  The study was sufficiently powered to confirm its primary hypothesis.  It showed that cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy.

  • The report also fails to mention multiple other studies (APPROACH, VICTORY, STARR, VADT, ACCORD, BARI 2D) that all corroborate the ischemic cardiovascular safety of Avandia.  None of these studies show a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events.

The absence in the Staff Report of any reference to the final results of the ADOPT, DREAM and RECORD studies, as well as other important studies on the ischemic cardiovascular safety of Avandia, leaves the record incomplete and does not s
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SOURCE GlaxoSmithKline
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