Lesinurad monotherapy in gout patients intolerant to a xanthine oxidase inhibitor: a 6 month phase 3 clinical trial and extension study

Management of serum uric acid sUA level is the most recommended therapy for gout patients. Until recently, the only uricosuric available in the USA was probenecid, while only probenecid and benzbromarone were available in the European Union. The results of the present study showed that Lesinurad 200 mg in combination with a xanthine oxidase inhibitor (XOI) significantly lowered the sUA. 

To examine the safety and efficiency of Lesinurad in a 6 month, phase 3 clinical trial and extension analysis.

The gout patients with ⩾6.5 mg/dl serum uric acid (sUA) and cannot take a xanthine oxidase inhibitor (XOI) were categorized to take oral 400 mg Lesinurad every day or placebo. The proportion of patients with sUA <6.0 mg/dl at sixth month was considered as the primary outcome. Treatment-emergent adverse events (TEAEs) and laboratory data were utilised for safety assessments. Patients who accomplished the analysis were suitable for an open-label, uncontrolled extension analysis of 400 mg Lesinurad monotherapy.

The patients took Lesinurad obtained significant primary outcome as compared to the placebo group. Overall TEAE rates were raised within Lesinurad group; renal-related serious TEAEs, renal-related TEAEs and increased serum creatinine levels present only among patients received Lesinurad. One hundred forty-three participants selected for the extension study. A fast and sustained reduced sUA obtained with the 400 mg Lesinurad treatment which continued for up to 18 months before the investigation was stopped prematurely. No new safety verdicts were seen during the extension analysis. 

Lesinurad 400 mg monotherapy showed higher sUA lowering than placebo, with maintained outcomes for up to 18 months within gout patients who intolerated to XOIs. Lesinurad should not be employed as monotherapy due to renal-related adverse events and high prevalence of serum creatinine elevations.