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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 <6.0 mg/dL and ≥2 gout flares in the prior year. Primary endpoint was achieving sUA <6.0 mg/dL at month 6.
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.