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Cited by 641Gout, Hyperuricemia, Uric AcidDrug-Induced Adverse ReactionsBiochemical and Molecular Research

Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28‐week, phase III, randomized, double‐blind, parallel‐group trial

Schumacher, H. RALPH, Becker, Michael A., Wortmann, Robert L., MacDonald, Patricia A., Hunt, Barbara, Streit, Janet, Lademacher, Christopher, Joseph‐Ridge, Nancy·2008·Arthritis Care & Research
DOI 10.1002/art.24209
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Abstract

Objective: To compare the urate‐lowering efficacy and safety of febuxostat, allopurinol, and placebo in a large group of subjects with hyperuricemia and gout, including persons with impaired renal function. Methods: Subjects (n = 1,072) with hyperuricemia (serum urate level ≥8.0 mg/dl) and gout with normal or impaired (serum creatinine level >1.5 to ≤2.0 mg/dl) renal function were randomized to receive once‐daily febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 weeks. Results: Significantly ( P ≤ 0.05) higher percentages of subjects treated with febuxostat 80 mg (48%), 120 mg (65%), and 240 mg (69%) attained the primary end point of last 3 monthly serum urate levels <6.0 mg/dl compared with allopurinol (22%) and placebo (0%). A significantly ( P < 0.05) higher percentage of subjects with impaired renal function treated with febuxostat 80 mg (4 [44%] of 9), 120 mg (5 [45%] of 11), and 240 mg (3 [60%] of 5) achieved the primary end point compared with those treated with 100 mg of allopurinol (0 [0%] of 10). Proportions of subjects experiencing any adverse event or serious adverse event were similar across groups, although diarrhea and dizziness were more frequent in the febuxostat 240 mg group. The primary reasons for withdrawal were similar across groups except for gout flares, which were more frequent with febuxostat than with allopurinol. Conclusion: At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.

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Crossref · 10.1002/art.24209

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  • Many studies report lack of effect of l-arginine on endothelial function markers, and sometimes l-arginine supplementation is associated with higher mortality after MI.

    “Many studies have reported a lack of effect on l-arginine in endothelial function markers, and on occasion, the supplementation of l-arginine has been associated with higher mortality effects, such as tests of l-arginine in patients after MI (835).”

    From Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation (2019) · cites this paper as [835]

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Authors
Schumacher, H. R., Becker, M. A., Wortmann, R. L., MacDonald, P. A., Hunt, B., Streit, J., Lademacher, C., & Joseph‐Ridge, N.
Affiliations
  • Philadelphia VA Medical Center (US)
  • University of Chicago (US)
  • Dartmouth College (US)
  • Takeda (United States) (US)
ORCID
Becker, Michael A.
Venue
Arthritis Care & Research
Publisher
Wiley
Published
2008-10-30
Volume
59
Issue
11
Pages
1540-1548
ISSN
  • 0893-7524 (ISSN-L)
  • 1529-0123
DOI
10.1002/art.24209
OpenAlex
W2000166571
Cited by
638
References
43
Citations by year
2026: 20 · 2025: 33 · 2024: 26 · 2023: 23 · 2022: 31 · 2021: 26 · 2020: 44 · 2019: 45 · 2018: 48 · 2017: 43 · 2016: 48 · 2015: 38 · 2014: 44 · 2013: 36 · 2012: 33
FWCI
26.55
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Arthritis Care & Research (publishedVersion)
  • PubMed (publishedVersion)
Funders
Takeda Pharmaceuticals North America
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
febuxostat, allopurinol, hyperuricemia, gout, urate-lowering therapy, renal dysfunction, gout flares, adverse events, drug safety, dose comparison, xanthine oxidase inhibitors, gout prevention, gouty nephropathy
MeSH terms
Febuxostat, Adult, Aged, Allopurinol, Creatinine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Gout, Gout Suppressants, Humans, Male, Middle Aged, Thiazoles, Uric Acid, Treatment Outcome, Hyperuricemia

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