Recent Findings Come From The CARES Trial, A Postmarketing Safety Study Requested By FDA Back When Uloric Was Approved In 2009
At the recent American College of Cardiology (ACC) 2018 Annual Scientific Session meeting, the gout drug Uloric (febuxostat) was the subject of some safety concerns due to findings about a higher risk of death when compared to an alternative gout drug, allopurinol. However, the mechanism behind this difference was not readily apparent.
Allopurinol, approved by the FDA in 1966, and Uloric, approved in 2009, are two commonly prescribed medicines for gout. Takeda Pharmaceuticals is the drug company responsible for Uloric.
The findings presented at this 2018 ACC meeting came from the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities (CARES) trial, or drug study, sponsored by Takeda Pharmaceuticals as an FDA postmarketing requirement.
From this March 12, 2018 MedPageToday news article, "Gout Drug Raises Safety Concerns With Death Excess in Trial", we get some commentary about this emerging drug safety issue for Uloric:
At this point, there is no known explanation for the mortality risk seen with [Uloric (febuxostat)], William White, MD, of the University of Connecticut in Farmington, reported here at the American College of Cardiology meeting late-breaking clinical trial session....
Despite the unclear mechanism, the consistency of the finding across the intent-to-treat and on-treatment analysis made the excess mortality risk "relatively robust" such that it "likely should be used to inform policy," said Noel Bairey Merz, MD, of Cedars-Sinai Hospital in Los Angeles and a member of the discussion panel at the session.
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The Uloric CARES findings presented on March 12, 2018 at the recent ACC meeting were simultaneously published online by the New England Journal of Medicine (NEJM) in this article, "Cardiovascular safety of febuxostat or allopurinol in patients with gout" (subscription required). From the "Conclusions" part of the Abstract for that NEJM article:
In patients with gout and major cardiovascular coexisting conditions, [Uloric (febuxostat)] was noninferior to allopurinol with respect to rates of adverse cardiovascular events. All-cause mortality and cardiovascular mortality were higher with [Uloric (febuxostat)] than with allopurinol.
Just last fall, in November 2017, the FDA issued a safety communication based on preliminary results from CARES. For more information, see this earlier piece: "Gout Medicine Uloric Safety Trial Shows Increased Risk Of Heart-Related Deaths According To November 2017 FDA Alert".
One expects the FDA will be looking closely at these new CARES findings about all-cause and cardiovascular deaths associated with Uloric over the next several months.
Similarly, it is presumed that safety analyses by those medical researchers involved with the CARES trial are ongoing to evaluate the unexpected higher mortality rates in patients using Uloric in comparison to allopurinol.
Of course, we will be watching for significant developments regarding the safety profile of Uloric.
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