Clinical Efficacy and Safety of Successful Longterm Urate Lowering with Febuxostat or Allopurinol in Subjects with Gout
Open accessAbstract
Objective.: To determine longterm urate-lowering efficacy and clinical benefits and safety of therapy with febuxostat or allopurinol in subjects with gout. Methods.: Subjects (n = 1086) in this open-label extension study were assigned to fixed-dose daily urate-lowering treatment (ULT) with febuxostat (80 mg or 120 mg) or allopurinol (300 mg). ULT reassignment was permitted during months 1 to 6 to achieve serum urate (SUA) concentrations between 3.0 and < 6.0 mg/dl. Flares requiring treatment, tophus size, safety, and SUA levels were monitored during up to 40 months of ULT maintenance. Results.: After 1 month initial treatment, > 80% of subjects receiving either febuxostat dose, but only 46% of subjects receiving allopurinol, achieved SUA < 6.0 mg/dl. After ULT reassignment, > 80% of all remaining subjects maintained the primary efficacy endpoint of SUA < 6.0 mg/dl at each visit. More subjects initially randomized to allopurinol required ULT reassignment to achieve SUA < 6.0 mg/dl compared with subjects receiving febuxostat. Maintenance of SUA < 6.0 mg/dl resulted in progressive reduction to nearly 0 in proportion of subjects requiring gout flare treatment. Baseline tophus resolution was achieved by 46%, 36%, and 29% of subjects maintained on febuxostat 80 mg, febuxostat 120 mg, and allopurinol, respectively. Overall adverse event rates (including cardiovascular adverse event rates), adjusted for 10-fold greater febuxostat than allopurinol exposure, did not differ significantly among treatment groups. Conclusion.: Durable maintenance of goal range SUA level with either dose of febuxostat or in smaller numbers of subjects with allopurinol resulted in near elimination of gout flares and improved tophus status over time. Registered as NCT00175019.
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Febuxostat was approved in 2008 in Europe and by the FDA in 2009 for the treatment of gout.
“Febuxostat was approved in 2008 in Europe and by the Food and Drug Administration in 2009 for the treatment of gout (commercial name Uloric in United States, Adenuric in Europe) (76, 77, 837).”
From Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation (2019) · cites this paper as [76]
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- Authors
- BECKER, M. A., SCHUMACHER, H. R., MacDONALD, P. A., LLOYD, E., & LADEMACHER, C.
- Affiliations
- University of Chicago (US)
- University of Pennsylvania (US)
- Takeda (Japan) (JP)
- ORCID
- BECKER, MICHAEL A.
- Venue
- The Journal of Rheumatology
- Publisher
- The Journal of Rheumatology
- Published
- 2009-03-13
- Volume
- 36
- Issue
- 6
- Pages
- 1273-1282
- ISSN
- 0315-162X (ISSN-L)
- 1499-2752
- OpenAlex
- W2145066076
- Cited by
- 269
- References
- 23
- Citations by year
- 2026: 2 · 2025: 8 · 2024: 6 · 2023: 10 · 2022: 15 · 2021: 10 · 2020: 21 · 2019: 22 · 2018: 18 · 2017: 19 · 2016: 24 · 2015: 15 · 2014: 24 · 2013: 20 · 2012: 15
- FWCI
- 12.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Rheumatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Nephrology › Gout, Hyperuricemia, Uric Acid
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Biochemical and Molecular Research
- Keywords
- gout, febuxostat, allopurinol, urate-lowering therapy, serum uric acid, gout flares, long-term maintenance therapy, cardiovascular adverse events, drug safety
- MeSH terms
- Febuxostat, Allopurinol, Gout, Gout Suppressants, Thiazoles, Uric Acid, Treatment Outcome, Hyperuricemia
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