U.S. health regulators said today said that a safety review did not find a connection between abacavir and an increased risk of heat attacks. Abacavirâ€”sold under brand names Ziagen, Trizivir, and Epzicom â€“ is used in the treatment of HIV-1 infection.
In the past, the U.S. Food & Drug Administration (FDA) has received conflicting information about a possible connection between abacavir treatment and heart attacks. According to the agency, several observational studies and one randomized control trial have noted an increased risk of heart attack associated with abacavir. But the same risk had not been seen in other randomized control trials and the safety database maintained GlaxoSmithKline.
Today, the FDA said its own meta-analysis of 26 randomized clinical trials that evaluated abacavir did not show an increased risk of heart attack. The meta-analysis, which involved more than 9,000 people on abacavir or a non-abacavir treatment regimen, included 16 trials from the drug manufacturer database, 5 from the AIDS Clinical Trials Group (ACTG), and 5 from academic centers. A total of 46 myocardial infarction (heart attack) events were noted. According to the FDA, 24 of these events occurred in the abacavir group, and 22 in the non-abacavir group. The difference between the two groups was not statistically significant, the FDA says.
The FDA has advised healthcare professionals to continue to prescribe abacavir according to the professional label. However, they should be aware that there are conflicting data on whether abacavir treatment increases the risk of heart attacks. Patients should not stop taking their abacavir without first talking to their healthcare professional.
The FDA said it will continue to communicate any new abacavir safety information to the public as it becomes available.