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Randomized Controlled Trial of Febuxostat Versus Allopurinol or Placebo in Individuals with Higher Urinary Uric Acid Excretion and Calcium Stones

Clinical journal of the American Society of Nephrology, 2013-11, Vol.8 (11), p.1960-1967 [Peer Reviewed Journal]

Copyright © 2013 by the American Society of Nephrology 2013 ;ISSN: 1555-9041 ;EISSN: 1555-905X ;DOI: 10.2215/CJN.01760213 ;PMID: 23929928

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Title:
Randomized Controlled Trial of Febuxostat Versus Allopurinol or Placebo in Individuals with Higher Urinary Uric Acid Excretion and Calcium Stones
Author: Goldfarb, David S ; MacDonald, Patricia A ; Gunawardhana, Lhanoo ; Chefo, Solomon ; McLean, Lachy
Subjects: Adult ; Allopurinol - adverse effects ; Allopurinol - therapeutic use ; Biomarkers - urine ; Calcium Oxalate - metabolism ; Double-Blind Method ; Enzyme Inhibitors - adverse effects ; Enzyme Inhibitors - therapeutic use ; Febuxostat ; Female ; Humans ; Male ; Middle Aged ; Multidetector Computed Tomography ; Original ; Thiazoles - adverse effects ; Thiazoles - therapeutic use ; Time Factors ; Treatment Outcome ; United States ; Uric Acid - urine ; Urinary Calculi - diagnostic imaging ; Urinary Calculi - drug therapy ; Urinary Calculi - urine ; Xanthine Oxidase - antagonists & inhibitors ; Xanthine Oxidase - metabolism
Is Part Of: Clinical journal of the American Society of Nephrology, 2013-11, Vol.8 (11), p.1960-1967
Description: Higher urinary uric acid excretion is a suspected risk factor for calcium oxalate stone formation. Febuxostat, a xanthine oxidoreductase inhibitor, is effective in lowering serum urate concentration and urinary uric acid excretion in healthy volunteers and people with gout. This work studied whether febuxostat, compared with allopurinol and placebo, would reduce 24-hour urinary uric acid excretion and prevent stone growth or new stone formation. In this 6-month, double-blind, multicenter, randomized controlled trial, hyperuricosuric participants with a recent history of calcium stones and one or more radio-opaque calcium stone ≥ 3 mm (as seen by multidetector computed tomography) received daily febuxostat at 80 mg, allopurinol at 300 mg, or placebo. The primary end point was percent change from baseline to month 6 in 24-hour urinary uric acid. Secondary end points included percent change from baseline to month 6 in size of index stone and change from baseline in the mean number of stones and 24-hour creatinine clearance. Of 99 enrolled participants, 86 participants completed the study. Febuxostat led to significantly greater reduction in 24-hour urinary uric acid (-58.6%) than either allopurinol (-36.4%; P=0.003) or placebo (-12.7%; P<0.001). Percent change from baseline in the size of the largest calcium stone was not different with febuxostat compared with allopurinol or placebo. There was no change in stone size, stone number, or renal function. No new safety concerns were noted for either drug. Febuxostat (80 mg) lowered 24-hour urinary uric acid significantly more than allopurinol (300 mg) in stone formers with higher urinary uric acid excretion after 6 months of treatment. There was no change in stone size or number over the 6-month period.
Publisher: United States: American Society of Nephrology
Language: English
Identifier: ISSN: 1555-9041
EISSN: 1555-905X
DOI: 10.2215/CJN.01760213
PMID: 23929928
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central
Alma/SFX Local Collection

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Randomized Controlled Trial of Febuxostat Versus Allopurinol or Placebo in Individuals with Higher Urinary Uric Acid Excretion and Calcium Stones

Copyright © 2013 by the American Society of Nephrology 2013 ;ISSN: 1555-9041 ;EISSN: 1555-905X ;DOI: 10.2215/CJN.01760213 ;PMID: 23929928

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