Discontinuing a non-steroidal anti-inflammatory drug (NSAID) in patients with knee osteoarthritis: Design and protocol of a placebo-controlled, noninferiority, randomized withdrawal trial.
Discontinuing a non-steroidal anti-inflammatory drug (NSAID) in patients with knee osteoarthritis: Design and protocol of a placebo-controlled, noninferiority, randomized withdrawal trial.
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DOI：
10.1016/j.cct.2017.11.020
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发表时间：
2018-02
影响因子：
2.2
通讯作者：
J. Goulet;E. Buta;M. Brennan;A. Heapy;L. Fraenkel
中科院分区：
文献类型：
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作者：
J. Goulet;E. Buta;M. Brennan;A. Heapy;L. Fraenkel
膝关节骨关节炎（OA）是老年人膝关节疼痛最常见的原因。尽管支持其使用的数据有限，但非甾体抗炎药（NSAID）是膝关节OA最常用的处方药之一。使用非甾体抗炎药治疗膝关节疼痛值得仔细检查，因为与这类药物的毒性。MethodsWe描述了一个安慰剂对照，非劣效性，随机退出试验的设计，检查疼痛的膝关节OA患者的非甾体抗炎药的中止。参与者将是在VA医疗保健系统中登记的患有膝关节OA疼痛的退伍军人，尽管使用NSAID和/或NSAID毒性风险相对较高。在两周的导入期后，合格受试者将用研究NSAID（美洛昔康）替代其当前NSAID，剩余合格受试者（目标N = 544）将随机接受四周安慰剂或继续美洛昔康治疗。主要结局是随机分组后4周的膝关节疼痛（西安大略和麦克马斯特大学骨关节炎指数疼痛子量表，范围0-20）。主要假设是安慰剂在非劣效性界值1内非劣效于（即，不比美洛昔康差太多）美洛昔康。次要结果包括下肢残疾，全球印象的变化，坚持研究药物和使用co-therapy.DiscussionThis研究是迄今为止第一个临床试验检查撤销非甾体抗炎药OA膝关节疼痛的影响。如果成功的话，这项试验将提供证据，反对在OA膝关节疼痛患者中继续使用NSAID。registrationClinicalTrials.gov 2013年2月22日注册。
BackgroundKnee osteoarthritis (OA) is the most common cause of knee pain in older adults. Despite the limited data supporting their use, non-steroidal anti-inflammatory drugs (NSAID) are among the most commonly prescribed medications for knee OA. The use of NSAIDs for knee pain warrants careful examination because of toxicity associated with this class of medications.MethodsWe describe the design of a placebo-controlled, noninferiority, randomized withdrawal trial to examine discontinuation of an NSAID in patients with painful knee OA. Participants will be veterans enrolled in the VA Healthcare System with knee OA pain despite NSAID use and/or relatively higher risk of NSAID toxicity. After a two-week run-in period where eligible subjects will replace their current NSAID with the study NSAID (meloxicam), those remaining eligible (target N = 544) will be randomized to receive four weeks of either placebo or continued meloxicam. The primary outcome is knee pain (Western Ontario and McMaster Universities Osteoarthritis Index pain subscale, range 0—20) at four weeks post-randomization. The primary hypothesis is that placebo will be noninferior to (that is, not much worse than) meloxicam within a noninferiority margin of 1. Secondary outcomes include lower extremity disability, global impression of change, adherence to study medication and use of co-therapies.DiscussionThis study is the first clinical trial to date examining the effects of withdrawing an NSAID for OA knee pain. If successful, this trial will provide evidence against the continued use of NSAIDs in patients with OA knee pain.Trial registrationClinicalTrials.gov: NCT01799213. Registered February 22, 2013.