Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout -: A randomized controlled trial
Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout -: A randomized controlled trial
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DOI：
10.1002/art.20007
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发表时间：
2004-02-01
影响因子：
--
通讯作者：
Geba, GP
中科院分区：
文献类型：
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作者：
Rubin, BR;Burton, R;Geba, GP
目标。评价依托瑞昔布与吲哚美辛治疗急性痛风的疗效和安全性。在42个地点进行了一项随机、双盲、主动比较研究。共有189名临床诊断为痛风的急性发作（小于或等于48小时）的男性和女性（大于或等于18岁）使用依托昔布120 mg/天（n = 103）或吲哚美辛50 mg/天3次（n = 86）治疗8天。主要疗效终点是患者在2-5天内对研究关节疼痛的评估（0-4分李克特量表）。安全性通过试验期间发生的不良经历（ae）进行评估。在患者对研究关节疼痛的评估方面，依托昔布的临床疗效与吲哚美辛相当。第2-5天的平均变化与基线的差异为-0.08(95%置信区间-0.29,0.13)(P = 0.46)，落在预先指定的-0.5至0.5的可比性范围内。8天研究的次要终点，包括疗效的开始、炎症症状的减少、患者和研究者对治疗反应的总体评估，证实了两种治疗的可比性。依托昔布组不良事件发生率（43.7%）低于吲哚美辛组（57.0%），药物相关不良事件发生率（16.5%）低于吲哚美辛组（37.2%），P < 0.05。依托昔布每日一次120毫克的剂量被证实是治疗急性痛风的有效方法。依托昔布的疗效与吲哚美辛相当，剂量为50mg，每日3次，通常是安全且耐受性良好的。
Objective. To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout.Methods. A randomized, double-blind, active-comparator study was conducted at 42 sites. A total of 189 men and women (greater than or equal to18 years of age) who were experiencing an acute attack (less than or equal to48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n = 103), or indomethacin, 50 mg 3 times a day (n = 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0-4-point Likert scale) over days 2-5. Safety was assessed by adverse experiences (AEs) occurring during the trial.Results. Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2-5 was -0.08 (95% confidence interval -0.29, 0.13) (P = 0.46), which fell within the prespecified comparability bounds of -0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigator's global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacin-treated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05).Conclusion. Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated.