Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Febuxostat in Gout
Studying safety and efficacy in patients with renal impairment
Patients with gout and moderate-to-severe renal impairment who were randomized to febuxostat demonstrated significantly lower serum uric acid (sUA) and no significant deterioration in renal function. This according to a study of 96 patients with gout and moderate-to-severe renal impairment randomized to receive febuxostat 30 mg BD, febuxostat 40/80 mg QD, or placebo. Researchers found:
- At month 12, there were no significant differences in serum creatine change from baseline (CFB) in either febuxostat group vs placebo.
- At month 12, there were no significant differences in estimated glomerular filtration rate CFB.
- The proportion of patients at month 12 with sUA < 6.0 mg/dL was significantly greater in both febuxostat groups vs placebo.
- Treatment-emergent adverse events (TEAE) occurred in 78.1%, 87.5%, and 78.1% of febuxostat 30 mg BD, febuxostat 40/80 mg QD, and placebo users, respectively.
- Most frequent TEAEs involved renal impairment and renal function analyses categories.
Citation: Saag KG, Whelton A, Becker M, MacDonald P, Hunt B, Gunawardhana L. Impact of febuxostat on renal function in gout subjects with moderate-to-severe renal impairment. [Published online ahead of print February 19, 2016]. Arthr Rheumatol. doi: 10.1002/art.39654.