August 30, 2012
FDA Analysis: Abacavir Doesn't Increase Heart Attack Risk
There is no association between the use of ViiV Healthcare’s abacavir—found in Ziagen, Epzicom and Trizivir—and heart attack risk, according to an analysis conducted by the U.S. Food and Drug Administration (FDA) published ahead of print in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). The FDA’s analysis of 26 clinical trials challenges the results of other studies in which abacavir was linked to an increased risk of heart attacks. In the studies reviewed by the FDA, which involved nearly 10,000 people who received HIV treatment between 1996 and 2010, 0.48 percent of those using abacavir-containing regimens experienced a heart attack, compared with 0.46 percent of those using abacavir-free regimens. This difference, the FDA authors concluded, was negligible and not statistically significant. The final results published in JAIDS are similar to those of a preliminary analysis presented by the FDA at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) in February 2011.
To read the JAIDS paper (paid subscription required), click here.
To read coverage of the preliminary results shared at the 18th CROI, click here.
Search: hiv, fda, abacavir, epzicom, ziagen, heart attack, myocardial infarction, mi
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