Thus, the investigators discovered that, although patients treated with febuxostat had similar overall rates of major adverse cardiovascular events as patients treated with allopurinol, the excess in cardiovascular deaths in the febuxostat group translated into a higher all-cause mortality.
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“The finding was a bit confusing,” acknowledges coauthor Kenneth G. Saag, MD, MSc, professor of medicine at the University of Alabama School of Medicine, Birmingham, in an interview with The Rheumatologist. “It raises more questions than [provides] answers at this point,” he adds. Moreover, he notes that many of the deaths occurred well after patients had stopped the study medications.
When the researchers analyzed the cardiovascular events by subgroup, they saw no heterogeneity associated with any of the baseline factors. However, they did find patients who also took non-steroidal anti-inflammatory drugs (NSAIDs) were more likely to experience cardiovascular deaths. Because NSAIDs may be associated with more frequent gout flares, researchers propose that the increase in cardiovascular deaths may be associated with gout flares. However, Dr. Saag notes that if a difference in flares existed between the two treatment groups, it was not captured in the study.
The new data reinforce the understanding that physicians should assess cardiovascular health in patients with gout. Moreover, Dr. Saag suggests that doctors discuss the new data with their patients, saying, “We have a new safety signal that they should be aware of.” He also says that a large European study is currently underway that may soon provide additional information for physicians and patients.
Lara C. Pullen, PhD, is a medical writer based in the Chicago area.
- White WB, Saag KG, Becker MA, et al. Cardiovascular safety of febuxostat or allopurinol in patients with gout. N Engl J Med. 2018 Mar 29;378(13):1200–1210. Epub 2018 Mar 12.