Clinical Gout-Related Benefits Not Demonstrated With Lesinurad Combination Therapy

Recent data published in Pharmacotherapy suggest that although a combination of lesinurad 200 mg and xanthine oxidase inhibitor (XOI) therapy was effective and well-tolerated among patients with gout who have not achieved adequate response with XOI monotherapy, clinical gout-related outcomes were not improved.

Researchers conducted a systematic review and meta-analysis of 5 randomized controlled trials that assessed the efficacy and safety of lesinurad in patients with hyperuricemia associated with gout (n=1959). The primary outcomes of the study were the proportion of patients achieving target serum uric acid levels by 6 months and the mean levels achieved at 6 and 12 months. The secondary outcome was the number of treatment-emergent adverse events.

Results showed that compared with XOI monotherapy, lesinurad 200 mg or 400 mg in combination with allopurinol or febuxostat yielded a higher percentage of patients who achieved target serum uric acid levels (<6.0 mg/dL or <5.0 mg/dL, respectively), by 6 months. Patients who received lesinurad with XOI also had lower mean serum uric acid levels at 6 and 12 months compared with XOI monotherapy. However, when researchers examined gout-related outcomes, including mean rates of gout flares that required treatment and patients who achieved tophi resolution, none of the treatment groups favored lesinurad.

The investigators also noted that the number of treatment-emergent adverse events was similar between the lesinurad 200 mg plus XOI group and the XOI monotherapy group. Lesinurad 400 mg monotherapy demonstrated superior efficacy compared with placebo, but significantly more adverse events occurred in this group.

The authors concluded that because gout-related clinical benefits were not improved, “longer-term studies are needed to support the cost effectiveness and safety of lesinurad in combination with XOI therapy in patients with gout.”

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Reference

Wu JY, Chang YT, Lin YC, et al. Efficacy and safety of lesinurad in patients with hyperuricemia associated with gout: a systematic review and meta-analysis of randomized controlled trials [published online September 23, 2018]. Pharmacotherapy. doi:10.1002/phar.2183