MEXICO CITY, Aug. 6, 2008 --
GlaxoSmithKline (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.
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.
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.
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