ORLANDO – Long-term treatment with febuxostat in gout patients with comorbid cardiovascular disease conferred significantly higher risks of both cardiovascular death and all-cause mortality, compared with allopurinol, in the Food and Drug Administration–mandated postmarketing CARES trial, William B. White, MD, reported at the annual meeting of the American College of Cardiology.
CARES (Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout and Cardiovascular Disease) was a prospective, double-blind, 320-center North American clinical trial in which 6,190 patients were randomized to febuxostat (Uloric) at 40-80 mg once daily or 200-600 mg of allopurinol once daily. The postmarketing safety study was required by the FDA as a condition of marketing approval for febuxostat in light of preapproval evidence suggestive of a possible increased risk of cardiovascular events, explained Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut, Farmington.
Bruce Jancin/Frontline Medical News
Dr. William B. White