Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison
Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison
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DOI：
10.1016/s0140-6736(07)60234-7
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发表时间：
2007-02-10
期刊：
影响因子：
168.9
通讯作者：
Cannon, Christopher P.
中科院分区：
文献类型：
--
作者：
Laine, Loren;Curtis, Sean P.;Cannon, Christopher P.
背景环氧化酶（考克斯）-2选择性抑制剂与传统非甾体抗炎药（NSAID）相比的上消化道安全性尚未在模拟标准临床实践的试验中评估。我们的目的是评估这些药物对胃肠道预后的影响，包括服用胃肠道保护性治疗的患者。（每日60或90 mg）和双氯芬酸在34701例骨关节炎或类风湿性关节炎患者中，（出血、穿孔、梗阻或溃疡）和并发事件子集（穿孔、梗阻、目击溃疡出血或显著出血）。我们还评估了同时服用质子泵抑制剂（PPI）或低剂量阿司匹林的患者的结局。这些试验在ClinicalTrials.gov上注册，编号为NCT 00092703、NCT 00092742和NCT 00250445。研究结果依托考昔组的总体上消化道临床事件发生率显著低于双氯芬酸组（风险比[HR] 0.69，95%CI 0.57-0.83; p=0.0001）。与双氯芬酸组相比，依托考昔组的非并发性胃肠道事件明显较少（0.57，0.45-0.74; p
Background Upper gastrointestinal safety of cyclo-oxygenase (COX)-2 selective inhibitors versus traditional non-steroidal anti-inflammatory drugs (NSAIDs) has not been assessed in trials that simulate standard clinical practice. Our aim was to assess the effects of these drugs on gastrointestinal outcomes in a population that includes patients taking gastrointestinal protective therapy.Methods A prespecified pooled intent-to-treat analysis of three double-blind randomised comparisons of etoricoxib (60 or 90 mg daily) and diclofenac (150 mg daily) in 34701 patients with osteoarthritis or rheumatoid arthritis was done for upper gastrointestinal clinical events (bleeding, perforation, obstruction, or ulcer) and the subset of complicated events (perforation, obstruction, witnessed ulcer bleeding, or significant bleeding). We also assessed such outcomes in patients who were taking concomitant proton pump inhibitors (PPIs) or low-dose aspirin. These trials are registered with ClinicalTrials.gov, with the numbers NCT00092703, NCT00092742, and NCT00250445.Findings Overall upper gastrointestinal clinical events were significantly less common with etoricoxib than with diclofenac (hazard ratio [HR) 0.69, 95% CI 0.57-0.83; p=0.0001). There were significantly fewer uncomplicated gastrointestinal events with etoricoxib than there were with diclofenac (0.57, 0.45-0.74; p