论文部分内容阅读
阿斯利康公布治疗痛风新药lesinurad伍用别嘌醇(allopurinol)的2次关键Ⅲ期临床试验资料。该药为选择性尿酸重吸收剂,而别嘌醇为黄嘌呤氧化酶抑制剂。Ⅲ期临床CLEAR1和CLEAR2试验是为期12个月的多中心、随机、安慰剂对照研究,分别入选603名和610名在12个月中痛风发作≥2次患者,比较lesinurad(200或400 mg/d)伍用别嘌醇(至少300 mg/d)组、别嘌醇单药组和安慰剂组的药效和安全性。在2次Ⅲ期临床试验中,lesinurad伍用别嘌醇组6个月时均达到主终点目标。别嘌醇单用组和2个伍用别嘌醇
AstraZeneca Announces 2 Critical Phase III Clinical Trials for the Treatment of Gout New Drugs Lesinurad with Allopurinol. The drug is a selective uric acid reabsorbent, and allopurinol is a xanthine oxidase inhibitor. The Phase III clinical CLEAR1 and CLEAR2 trials, a 12-month, multicenter, randomized, placebo-controlled study, enrolled 603 and 610 patients with gout episodes ≥ 2 at 12 months, compared with lesinurad (200 or 400 mg daily ) With allopurinol (at least 300 mg / d), allopurinol and placebo group efficacy and safety. In two phase III trials, lesinurad arms achieved the primary endpoint goal at 6 months with allopurinol. Allopurinol group and two with allopurinol group