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
References
Apr 1, 1977·Arthritis and Rheumatism·S L WallaceT F Yü
Mar 8, 2005·Arthritis and Rheumatism·Michael A BeckerNancy Joseph-Ridge
Dec 13, 2005·The New England Journal of Medicine·Michael A BeckerNancy Joseph-Ridge
Nov 21, 2007·Hematology·Marcie R Tomblyn, J Douglas Rizzo
Nov 1, 2008·Arthritis and Rheumatism·H Ralph SchumacherNancy Joseph-Ridge
Jan 15, 2009·Rheumatology·H R SchumacherC Lademacher
Mar 17, 2009·The Journal of Rheumatology·Michael A BeckerChristopher Lademacher
Apr 8, 2010·Arthritis Research & Therapy·Michael A BeckerChristopher Lademacher
Jun 29, 2010·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Sumithra J Mandrekar, Daniel J Sargent
Dec 21, 2010·Journal of Clinical Rheumatology : Practical Reports on Rheumatic & Musculoskeletal Diseases·Andrew WheltonLhanoo Gunawardhana
Aug 5, 2011·BMC Nephrology·Mahesh J FuldeoreEswar Krishnan
May 26, 2012·The American Journal of Medicine·Yanyan ZhuHyon K Choi
Oct 2, 2012·Arthritis Care & Research·Dinesh KhannaUNKNOWN American College of Rheumatology
Dec 5, 2012·PloS One·Eswar Krishnan
Feb 9, 2013·Postgraduate Medicine·Andrew WheltonLhanoo Gunawardhana
Apr 2, 2013·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Richard J JohnsonEberhard Ritz
Feb 14, 2015·Clinical and Experimental Nephrology·Kenichi TanakaTsuyoshi Watanabe
Apr 19, 2015·Arthritis Research & Therapy·Matthew J RoughleyEdward Roddy
May 23, 2015·Hemodialysis International·Yuki TsurutaKosaku Nitta
Aug 4, 2015·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Dipankar SircarRajendra Pandey
Feb 20, 2016·Arthritis & Rheumatology·Kenneth G SaagLhanoo Gunawardhana
Mar 21, 2017·Annals of the Rheumatic Diseases·Lisa K StampNicola Dalbeth
Citations
Aug 4, 2018·Arthritis & Rheumatology·Kenneth G SaagLhanoo Gunawardhana
Dec 17, 2019·Current Opinion in Rheumatology·Abhishek Abhishek
Jul 25, 2019·Medicine·Tsu-Chen LinMei-Yi Wu
Aug 1, 2020·Expert Opinion on Drug Safety·Giovanna RosasKenneth G Saag
Jan 23, 2020·Clinical Rheumatology·Yu-Jiun LinShy-Shin Chang
Feb 2, 2021·Rheumatology Advances in Practice·Hamish FarquharLisa K Stamp
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
Jun 26, 2021·Pharmacotherapy·Siliang ZhangYuan Yu