Lesinurad combination therapy increased serum uric acid levels in patients with gout
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The combined use of a selective uric acid reabsorption inhibitor with allopurinol significantly increased the number of patients with gout who met their serum uric acid levels compared with use of allopurinol alone, according to results of two studies presented at the American College of Rheumatology Annual Meeting in Boston.
“There has not been much development over the last 30 years in treatment options for the millions of patients who fail to reach target serum uric acid levels on current standard-of-care therapy, such as allopurinol alone,” Kenneth G. Saag, MD, lead study author and professor of medicine at the University of Alabama in Birmingham, Ala., said in a press release. “The results from this first-of-its-kind, large phase 3 trial demonstrate the potential of combination therapy with lesinurad to provide a future treatment option for gout patients on allopurinol where additional therapy is needed.”
The replicate studies, CLEAR1 and CLEAR2, compared the serum uric acid (sUA) levels of 603 and 610 patients, respectively, who were treated with either 200 mg or 400 mg of lesinurad combined with allopurinol (AstraZeneca) with those of patients who were treated with allopurinol alone. Inclusion criteria included a baseline sUA of 6.5 mg/dL or higher. All patients were on 300 mg of allopurinol or higher regardless of treatment. Patient demographics were similar between the groups.
In CLEAR1, 54% of patients in the 200-mg lesinurad group and 59% in the 400-mg lesinurad group met their target sUA levels of less than 6 mg/dL compared with 28% in the allopurinol group. CLEAR2 trial results showed 55% of patients in the 200-mg and 67% of patients in the lesinurad group meeting their sUA target compared with 23% in the allopurinol group.
Additional results from the phase 3 clinical trial program will be submitted to a scientific meeting in 2015, according to the release.
Reference:
Saag KG. Paper #L10. Presented at: American College of Rheumatology Annual Meeting. Nov. 14-19, 2014; Boston.
Disclosure: See the study for a full list of all authors’ relevant financial disclosures.