Rofecoxib, a new cyclooxygenase 2 inhibitor, shows sustained efficacy, comparable with other nonsteroidal anti-inflammatory drugs -: A 6-week and a 1-year trial in patients with osteoarthritis
Rofecoxib, a new cyclooxygenase 2 inhibitor, shows sustained efficacy, comparable with other nonsteroidal anti-inflammatory drugs -: A 6-week and a 1-year trial in patients with osteoarthritis
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DOI：
10.1001/archfami.9.10.1124
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发表时间：
2000-11-01
期刊：
影响因子：
--
通讯作者：
Daniels, B
中科院分区：
文献类型：
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作者：
Saag, K;van der Heijde, D;Daniels, B
简介：罗非考昔是一种环氧合酶 2 抑制剂（有时称为特异性环氧合酶 2 抑制剂或考昔布），用于治疗骨关节炎 (OA)。已发表的信息表明，与非选择性非甾体类抗炎药 (NSAID) 相比，罗非考昔的胃肠道安全性得到改善。 目的：在 2 项研究中评估罗非考昔治疗 OA 的有效性和安全性。 方法：使用相同的进入标准和终点，对膝关节或髋关节 OA 患者进行了两项随机、双盲、平行组研究。一项针对 736 名患者进行的为期 6 周的安慰剂对照试验比较了 12.5 和 25 mg 罗非考昔每日一次与 800 mg 布洛芬每日 3 次，一项为期 1 年的研究在 693 名患者中比较了 12.5 和 25 mg 罗非考昔每日一次与 50 mg 双氯芬酸每日 3 次。结果：罗非昔布，每天 12.5 和25 mg，临床疗效与布洛芬相当，根据预先确定的可比性标准通过 3 个主要终点进行评估。 6 周时，罗非昔布剂量和布洛芬在所有主要终点上均比安慰剂具有显着更高的疗效。罗非昔布剂量和双氯芬酸在一年内显示出相似的疗效。所有治疗均具有良好的耐受性。结论：罗非昔布每日一次给药可有效治疗 OA，持续 6 周和 1 年。罗非昔布在 OA 患者中通常安全且耐受性良好，持续时间为 6 周和 1 年。
Introduction: Rofecoxib, a cyclooxygenase 2 inhibitor (sometimes known as a specific cyclooxygenase 2 inhibitor or Coxib), is used in osteoarthritis (OA). Published information indicates rofecoxib's improved gastrointestinal safety profile over nonselective nonsteroidal anti-inflammatory agents (NSAIDs).Objective: To evaluate the efficacy and safety of rofecoxib in treating OA in 2 studies.Methods: Two randomized, double-blind, parallel-group studies in patients with OA of the knee or hip were conducted using identical entry criteria and end points. A 6-week placebo-controlled trial in 736 patients compared 12.5 and 25 mg of rofecoxib once daily with 800 mg of ibuprofen 3 times daily, and a 1-year study compared 12.5 and 25 mg of rofecoxib once daily with 50 mg of diclofenac 3 times daily in 693 patients.Results: Rofecoxib, at 12.5 and 25 mg, demonstrated efficacy clinically comparable with ibuprofen, assessed by 3 primary end points according to predefined comparability criteria. Both rofecoxib doses and ibuprofen provided significantly greater efficacy than placebo on all primary end points at 6 weeks. Both rofecoxib doses and diclofenac showed similar efficacy over 1 year. All treatments were well tolerated.Conclusions: Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year.