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Zurampic Helps Allopurinol Non-Responders

Aug 29, 2016 4:54 pm

Lesinurad (Zurampic) was approved earlier this year as adjunctive therapy to other urate-lowering therapies (ULT). It is a selective uric acid reabsorption inhibitor (URAT-1 inhibitor) designed to treat gout, and be used in combination with other xanthine oxidase inhibitors.

The results of the CLEAR 1 trial were pivotal in the FDA review of this drug and have been reported in the August issue of Arthritis & Rheumatology.

This was a 12-month, randomized, phase-III trial of lesinurad (200-mg or 400-mg qd) added to standard doses of allopurinol in gout patients with a serum urate (sUA) above

Gout patients (N=603) were predominantly male, a mean gout duration 11.8±9.4 years, and mean baseline sUA 6.94.

Lesinurad at 200-mg and 400-mg doses, added to allopurinol, significantly increased proportions of subjects achieving the sUA target. At month 6, 54.2% of lesinurad 200 mg/d, 59.2% of lesinurad 400 mg/d, and 27.9% of allopurinol patients achieved the goal.

Surprisingly, lesinurad was not significantly superior in secondary endpoints: rates of gout flares and complete tophus resolution. The safety profile showed the drug to be generally well-tolerated; but, there was a higher incidences of predominantly-reversible serum creatinine elevation in those on lesinurad.

Lesinurad may prove to be a useful option for patients inadequately controlled on allopurinol, or those who cannot increase their allopurinol dose above 300 mg per day to reduce sUA levels to target.

Disclosures
The author has received compensation as an advisor or consultant on this subject

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