According to a recent study, there are increased risks of Uloric heart side effects, including death risks for patients with heart disease, associated with the gout medication.

The study and its findings were published in the New England Journal of Medicine, by its principal investigator William B. White, also the study’s lead author. American College of Cardiology’s 67^th Annual Scientific Session first released the findings of the CARES trial on March 12, 2018.

The study reported an increased risk for Uloric heart side effects and risk of death for those with heart disease when taking Uloric (febuxostat), in comparison to those taking another drug, allopurinol.

The two gout medications are prescribed to limit the excess build-up of uric acid. Gout is a form of arthritis characterized by symptoms such as tenderness in joints, severe pain, and redness. There are more than eight million Americans that suffer from gout.

Cardiovascular problems linked to gout, or elevated uric acid levels, include high blood pressure, angina, and heart attack. The intense pain in the joint can result in the big toe or other joints of the body.

The study found that the two drugs were similar in respect to causing side effects such as nonfatal stroke, nonfatal heart attack, and urgent surgery for angina treatment. However, it found a higher risk of death due to cardiovascular causes in those taking Uloric.

White, a Calhoun Cardiology Center professor at the University of Connecticut School of Medicine, Uloric heart side effects were “entirely unexpected,” according to Managed Care. He added that “[t]he results were consistent across many subgroups; there was no evidence of a relationship with age, gender, race or ethnicity, history of cardiovascular disease, or duration or severity of the gout.”

He further stated that, “A very extensive preclinical evaluation of febuxostat showed no explanation for the excess in sudden cardiac deaths.”

CARES Trial

At this point, there has been no previous cardiovascular clinical trial that has shown cardiovascular death risks without connecting it to risks such as stroke and nonfatal heart attacks. Evidence during the study noted that there was no difference between patients taking allopurinol or febuxostat in association with side effects including arrhythmias, myocardial infarction, stroke, pulmonary embolism, or hospitalization from heart failure.

The CARES trial, looking into Uloric heart side effects, began in 2010 and continued for seven years. It evaluated more than 6,000 patients with gout at 320 North American centers.

Not only did the patients in the study have a gout condition but they also had cardiovascular diseases including peripheral arterial disease, unstable angina, stroke, heart attack, small vessel disease, and diabetes. The participants were randomly assigned either febuxostat or allopurinol. To mitigate any biases, neither the physicians nor the patients knew which medication they had received.

For a duration between two and six and a half years years, patients had their health outcomes and Uloric heart side effects with the medication tracked. Roughly 45 percent of patients discontinued the trial; in those who remained and discontinued taking febuxostat, death risks decreased.

The two medications were approved by the U.S Food and Drug Administration (FDA). Alloupurinol was approved in 1996, while febuxostat was approved in 2009.

The CARES trial was funded by Takeda Pharmaceuticals USA, Inc., which has a U.S subsidiary based in the Chicago area.