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Pooled-Analysis of 54 Clinical Studies Shows No Increased Risk of Heart Attack With Abacavir Therapy
Date:8/6/2008

MEXICO CITY, Aug. 6 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) (GSK) announced today that a review of data from over 14,600 patients in 54 clinical studies showed no increased risk of myocardial infarction associated with the anti-HIV medication abacavir. GSK conducted this review upon learning that the analysis undertaken by the D:A:D cohort had found an unexpected but potential association between highly active antiretroviral therapy (HAART) regimens containing abacavir and an increased risk of heart attack. GSK's review of its clinical trial database was presented today at the International AIDS Conference in Mexico City.

The analysis was conducted from a GSK internal database including data from 54 clinical trials. The review pooled data from 9,639 subjects on abacavir-containing HAART and 5,044 subjects on non-abacavir HAART. Overall, less than 30 heart attacks had been reported across the abacavir and non-abacavir groups and no increased risk of heart attack associated with abacavir was observed.

"GSK took the responsibility to examine the existing body of clinical data available to us as soon as we learned the results of the D:A:D cohort," said John Pottage, M.D., Vice President Global Clinical Development at GlaxoSmithKline. "The D:A:D findings were certainly unexpected and are inconsistent with what we have seen with our own data. GSK believes at this time that the D:A:D data are inconclusive."

In the GSK analysis the frequency of coronary artery disorders for both groups was very low and similar to the general population: 2.5 events per 1,000 people in the abacavir HAART and 4 events per 1,000 people in the non-abacavir HAART. Further, the frequency of heart attacks was 1.1 per 1,000 people in the abacavir HAART and 1.4 per 1,000 people in the non-abacavir HAART. GSK's review of clinical and pre-clinical data to date did not reveal a plausible biologic mechanism for the results seen in the D:A:D study.

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SOURCE GlaxoSmithKline
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