Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial

Objective To investigate the efficacy and safety of lesinurad in combination with febuxostat in a 12‐month phase III trial in patients with tophaceous gout. Methods Patients with serum urate (UA) ≥8.0 mg/dl (≥6.0 mg/dl with urate‐lowering therapy) and ≥1 measurable target tophus were given febuxosta...

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Published in:Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2017-09, Vol.69 (9), p.1903-1913
Main Authors: Dalbeth, Nicola, Jones, Graeme, Terkeltaub, Robert, Khanna, Dinesh, Kopicko, Jeff, Bhakta, Nihar, Adler, Scott, Fung, Maple, Storgard, Chris, Baumgartner, Scott, Perez‐Ruiz, Fernando
Format: Article
Language:English
Subjects:
Clinical trials
Creatinine
Creatinine - blood
Double-Blind Method
Drug Therapy, Combination
Febuxostat - administration & dosage
Female
Gout
Gout - blood
Gout - drug therapy
Gout - pathology
Gout Suppressants - administration & dosage
Humans
Male
Middle Aged
Patients
Reabsorption
Rheumatism
Safety
Therapy
Thioglycolates - administration & dosage
Treatment Outcome
Triazoles - administration & dosage
Uric acid
Uric Acid - blood
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Summary:Objective To investigate the efficacy and safety of lesinurad in combination with febuxostat in a 12‐month phase III trial in patients with tophaceous gout. Methods Patients with serum urate (UA) ≥8.0 mg/dl (≥6.0 mg/dl with urate‐lowering therapy) and ≥1 measurable target tophus were given febuxostat 80 mg/day for 3 weeks before randomization to receive lesinurad (200 or 400 mg daily) or placebo in addition to the febuxostat. The primary end point was the proportion of patients achieving a serum UA level of
ISSN:2326-5191
2326-5205
DOI:10.1002/art.40159