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

Arthritis Research & Therapy
Lhanoo GunawardhanaKenneth Saag

Abstract

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 release (XR) formulation of febuxostat was developed to provide equal or superior efficacy on urate lowering compared with the IR formulation and potentially lower the risk of treatment-initiated gout flares due to an altered pattern of drug exposure. The present study evaluated the efficacy and safety of febuxostat XR and IR formulations in patients with gout and moderate renal impairment (estimated glomerular filtrate rate ≥ 30 and < 60 ml/min). This was an exploratory, 3-month, phase II, multicenter, placebo-controlled, double-blind proof-of-concept study. Patients (n = 189) were randomized 1:1:1:1:1 to receive placebo or febuxostat IR 40 mg, XR 40 mg, IR 80 mg, or XR 80 mg once daily. Endpoints included: proportion of patients with serum uric acid (sUA) < 5.0 mg/dl at month 3 (primary endpoint), proportion of patients with sUA < 6.0 mg/dl at month 3, and proportion of patients with ≥ 1 gout flare requiring treatment over 3 months. At month 3, all febuxostat treatment groups were associated with greater proportions of patients achieving sUA < 5.0 mg/dl (...Continue Reading

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Citations

Dec 17, 2019·Current Opinion in Rheumatology·Abhishek Abhishek
Aug 1, 2020·Expert Opinion on Drug Safety·Giovanna RosasKenneth G Saag
Mar 9, 2021·Seminars in Nephrology·Christopher Estiverne, David B Mount
Aug 15, 2020·Mayo Clinic Proceedings. Innovations, Quality & Outcomes·Ahmad Al-AbdouhErin D Michos

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Methods Mentioned

BETA
blood drawn
pregnancy test

Clinical Trials Mentioned

NCT02128490

Software Mentioned

SAS System

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