Efficacy and safety of febuxostat extended release and immediate release in patients with gout and moderate renal impairment: phase II placebo-controlled study

• DOI: 10.1186/s13075-018-1593-0
• Publication Date: 2018-05-30T08:32:37Z
• Authors: Lhanoo Gunawardhana; Michael A. Becker; Andrew Whelton; Barbara Hunt; Majin Castillo; Kenneth Saag
• Keywords: Febuxostat; Xanthine oxidase inhibitor; Clinical endpoint

Febuxostat immediate release (IR), a xanthine oxidase inhibitor, is indicated for the management of hyperuricemia in patients with gout by lowering urate levels. An extended (XR) formulation febuxostat was developed to provide equal or superior efficacy on compared IR and potentially lower risk treatment-initiated flares due an altered pattern drug exposure. The present study evaluated safety XR formulations moderate renal impairment (estimated glomerular filtrate rate ≥ 30 < 60 ml/min).This exploratory, 3-month, phase II, multicenter, placebo-controlled, double-blind proof-of-concept study. Patients (n = 189) were randomized 1:1:1:1:1 receive placebo 40 mg, 80 mg once daily. Endpoints included: proportion serum uric acid (sUA) 5.0 mg/dl at month 3 (primary endpoint), sUA 6.0 3, 1 flare requiring treatment over months.At all groups associated greater proportions achieving (p 0.05 vs placebo). A receiving achieved versus those 0.034); similar groups. Higher febuxostat-treated placebo) experienced (significant comparisons, except mg). Incidences treatment-related adverse events low across groups; majority mild no apparent trends correlating doses. most common treatment-emergent event hypertension. One death (unrelated drug) reported.These exploratory data demonstrate that (XR IR) effective well tolerated impairment.ClinicalTrials.gov, NCT02128490 Registered 29 April 2014.