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Positive Results Reported for Gout Therapy Lesinurad in Phase III Trial
Treatment reduces serum uric acid (December 13)
Positive results have been reported from a phase III study investigating the potential of lesinurad (GlaxoSmithKline) as monotherapy in the small population of gout patients who are intolerant to, or otherwise cannot take, one or both xanthine oxidase inhibitors allopurinol (Zyloprim, Prometheus Laboratories, and generics) and febuxostat (Uloric, Takeda).
Lesinurad is an investigational agent being studied as a selective uric acid reabsorption inhibitor (SURI) that inhibits the URAT1 transporter, thereby normalizing uric acid excretion and reducing serum uric acid (sUA).
In the LIGHT (Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors) trial, lesinurad met the primary endpoint with a statistically significant (P < 0.0001) higher proportion of patients achieving the sUA goal of less than 6.0 mg/dL at 6 months compared with patients given placebo.
The patients treated with lesinurad monotherapy were more likely to experience serum creatinine elevations and renal adverse events, including serious events, compared with those in the placebo group. Other commonly reported adverse events in patients treated with lesinurad monotherapy were diarrhea, nausea, and constipation.
The LIGHT trial was conducted to assess the sUA-lowering effects and safety of once-daily lesinurad (400 mg) as monotherapy compared with placebo in 214 patients with sUA levels greater than or equal to 6.5 mg/dL (i.e., a highly symptomatic population with mean sUA levels of 9.3 mg/dL at baseline) who were intolerant of, or had a contraindication to, allopurinol or febuxostat.
Source: AstraZeneca; December 13, 2013.