Combining Lesinurad With Allopurinol in Inadequate Responders

Summary

This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.

Timeline

Start

2012-01

Primary completion

2014-07

Completion

2014-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Lesinurad 200 mg + Allopurinol vs Placebo + Allopurinol; p <0.0001; Risk Difference (RD) 0.26 (95% CI 0.17 to 0.36); Cochran-Mantel-Haenszel NCT01510158 ↗

registry analysis (superiority or other test); Lesinurad 400 mg + Allopurinol vs Placebo + Allopurinol; p <0.0001; Risk Difference (RD) 0.31 (95% CI 0.22 to 0.41); Cochran-Mantel-Haenszel NCT01510158 ↗

Publications

• Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.
• Saag KG, Fitz-Patrick D, Kopicko J, Fung M, Bhakta N, Adler S, Storgard C, Baumgartner S, Becker MA. Lesinurad Combined With Allopurinol: A Randomized, Double-Blind, Placebo-Controlled Study in Gout Patients With an Inadequate Response to Standard-of-Care Allopurinol (a US-Based Study). Arthritis Rheumatol. 2017 Jan;69(1):203-212. doi: 10.1002/art.39840.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lesinurad	Small molecule	200 mg	Oral
Subject	Lesinurad	Small molecule	400 mg	Oral
Comparator	Allopurinol	Small molecule	200 mg	—
Comparator	Allopurinol	Small molecule	300 mg	—

Indications