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Re-adjudication replays RECORD results

May 29, 2013 12:37 AM UTC

An independent re-adjudication of the RECORD cardiovascular outcomes trial of Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) showed that the diabetes drug was not associated with a significantly increased risk of cardiovascular events. The outcomes were consistent with the original analysis of the drug. The re-adjudication, which will be the subject of a June 5-6 FDA advisory committee meeting, was conducted by the Duke Clinical Research Institute. GSK posted a (see BioCentury Extra, Sept. 27, 2010).

The Duke researchers conducted a blinded, two-phase re-adjudication of the RECORD trial in 4,447 Type II diabetics showing no evidence that Avandia plus metformin or sulfonylurea increased the risk of all-cause mortality (6.3% vs. 7.2%, HR=0.86, 95% CI: 0.68, 1.08) or a composite of cardiovascular death, myocardial infarction (MI) or stroke (8.2% vs. 8.4%, HR=0.95, 95% CI: 0.78, 1.17) compared to metformin plus sulfonylurea. Additionally, under an adjusted definition of major adverse cardiovascular events (MACE) used for the re-adjudication, Avandia plus metformin or sulfonylurea led to a rate of cardiovascular death, MI or stroke of 8.4% vs. 8.6% for metformin plus sulfonylurea (HR=0.97, 95% CI: 0.79, 1.18). The original definition for MACE required non-fatal events to involve hospitalization, whereas the new definition for the re-adjudication did not. ...