Findings about the gout drug Uloric 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 were recently presented.
This was done on March 12, 2018 by two means:
- A presentation at the American College of Cardiology (ACC) 2018 Annual Scientific Session meeting; and,
- Published online by the New England Journal of Medicine (NEJM) in this article, “Cardiovascular safety of febuxostat or allopurinol in patients with gout”.
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.
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.
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.[View article at original source]