Affiliation:
1. Lebanon Veterans Affairs Medical Center, Lebanon, PA, USA
2. Presbyterian College School of Pharmacy, Clinton, SC, USA
3. Department of Pharmacy Practice, Presbyterian College School of Pharmacy, Clinton, SC, USA
Abstract
Objective: To review the pharmacokinetics, clinical efficacy, safety, and role of lesinurad for the management of hyperuricemia associated with gout. Data Selection: A MEDLINE search (2000 to April 2017) was conducted using the terms hyperuricemia, gout, URAT-1, URAT-1 transporter, and lesinurad. Published articles and scientific posters relevant to the efficacy and safety of lesinurad were reviewed and summarized. Data Synthesis: Lesinurad was evaluated in 3 randomized, phase 3 clinical trials (CRYSTAL, CLEAR 1 and 2). The primary endpoint for CRYSTAL trial was the percentage of patients achieving serum uric acid (SUA) concentration ≤ 5 mg/dL. The CLEAR 1 and 2 trials had a primary endpoint of percentage of patients achieving SUA concentration ≤ 6 mg/dL. Lesinurad at either 200 or 400 mg/d was superior to xanthine oxidase inhibitor (XOI) monotherapy in reducing the SUA concentration to 5 or 6 mg/dL, when added to either allopurinol or febuxostat. Conclusion: Data from phase 3 clinical studies suggest the addition of lesinurad to allopurinol or febuxostat is superior to XOI monotherapy alone in reducing SUA concentrations while increasing the risk of renal-related adverse events. Lesinurad, 200 mg orally per day, would be a safe recommendation, in combination with an XOI, among patients with adequate renal function (i.e., above 45 mL/min) who need additional therapy for inadequately controlled hyperuricemia associated with gout.
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11 articles.
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