A follow-up post-market clinical safety trial whose data was released in early March 2018 at the American College of Cardiology Conference in Orlando, Fla. showed that Uloric heart attack related deaths were statistically more numerous than those suffered by allopurinol users.

Uloric—which is also known generically as febuxostat—is a treatment for ongoing hyperuricemia or gout, an unusual form of arthritis that affects one to two joints at a time and is caused by elevated blood levels of uric acid. Uric acid deposits crystals in the affected joints—often the big toe—and it becomes reddened and inflamed with decreased range of motion.

According to the American College of Cardiology, the pre-approval trial commonly known as CARES showed potential markers for increased risk of Uloric heart attack related deaths and other cardiac events which warranted another study in the mind of U.S. Food and Drug Administration (FDA) leadership.

Prior to the FDA approval of febuxostat, allopurinol was the most common treatment choice among physicians addressing gout in their patients. Allopurinol is still more widely prescribed among doctors but for the purposes of follow-up study, half the enrolled participants were given Uloric and the other half given allopurinol. Now, post-approval, the FDA warns of Uloric risks.

Gout Sufferers

All enrollees in the study were gout patients who had serious risk factors for cardiovascular disease or events or prior incidence of same. The precise purpose of this choice was to pin down those potential markers for Uloric heart attack related deaths established before the drug went to market.

It should be noted that gout as a condition is often associated fairly or unfairly with indulgence with alcohol, red meats, poultry or seafood or other consumptives containing purines—the breakdown of which produces uric acid.

The disease develops more frequently in males than in females, and family history can also play a part. Concurrent risk factors include obesity, alcoholism, and diabetes. Gout, like all of these latter conditions, puts a strain on the heart, naturally leading to cardiovascular risk factors.

Uloric Heart Attack Related Deaths in the Follow-Up Study

The follow-up study enrolled 6,190 gout patients with active cardiovascular disease or serious risk factors for same. Of this number, 84 percent were men followed for a median of two years, eight months. Some were followed for as long as six and one-half years.

The final result from the follow-up study revealed a 34 percent higher risk of Uloric heart attack related deaths or death from other types of cardiovascular causes. When it came to enrollees dying from any other cause, the risk was still elevated while taking febuxostat by 22 percent.

The investigation, which was headed by William B. White MD, has still left researchers with lots of questions. Further study is warranted, according to the American College of Cardiology article. Data will continue to be examined in detail to figure out the best course of gout treatment for patients with chronic kidney disease as well as cardiovascular risk factors.