Febuxostat, a gout drug that has been in use for nearly a decade, was found to significantly increase the risk of death, even though it did not raise the risk of the trial’s primary endpoint, a combined rate of fatal and nonfatal adverse cardiovascular events, according to research presented at the American College of Cardiology’s 67th Annual Scientific Session.
It is unusual for a clinical trial to reveal an increased risk of death without also showing a heightened risk of other cardiovascular outcomes such as nonfatal heart attack and stroke. The findings, which showed an uptick in deaths after patients had been taking febuxostat for two years or longer, call into question the safety of long-term febuxostat use in patients with cardiovascular disease, researchers said.
“This finding was entirely unexpected, and we’re at a loss at this time to explain why this finding was seen,” said William B. White, MD, professor of medicine at the Calhoun Cardiology Center of the University of Connecticut School of Medicine and the study’s lead author. “The results were consistent across many subgroups; there was no evidence of a relationship with age, sex, race or ethnicity, history of cardiovascular disease, or duration or severity of the gout.”