Drug manufacturer GlaxoSmithKline (GSK) said 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. The review of the clinical trial database was presented at the International AIDS Conference in Mexico City Wednesday. U.K.-based 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 or HAART regimens containing abacavir and an increased risk of heart attack.
The analysis was conducted from a GSK internal database. 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.
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.
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.
Also, inflammatory biomarkers that may be associated with cardiac risk, hs-CRP and IL-6, were evaluated from the HEAT trial, a large, randomized, controlled study of Epzicom and Truvada. The levels of these important biomarkers decreased from baseline at both 48 and 96 weeks for both abacavir and tenofovir. Additionally, there were no significant differences between the active comparitors in the study.
GSK is currently trading at $48.96, up $0.35 or 0.72%, on 1.54 million shares.
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