A comparison of adverse renovascular experiences among osteoarthritis patients treated with rofecoxib and comparator non-selective non-steroidal anti-inflammatory agents
A comparison of adverse renovascular experiences among osteoarthritis patients treated with rofecoxib and comparator non-selective non-steroidal anti-inflammatory agents
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DOI：
10.1185/030079902125000354
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发表时间：
2002-01-01
影响因子：
2.3
通讯作者：
Reicin, A
中科院分区：
文献类型：
--
作者：
Gertz, BJ;Krupa, D;Reicin, A
背景：非选择性非甾体类抗炎药（NSAID）抑制两种环氧合酶（考克斯）同工酶，即考克斯-1和考克斯-2。罗非昔布是一种选择性抑制考克斯-2的药物，已被证明在骨关节炎（OA）和其他疼痛模型中提供与对照非选择性NSAID等效的抗炎和镇痛疗效，并显著改善胃肠道（GI）安全性和耐受性。基于肾生理学研究，预测罗非昔布的肾血管效应与非选择性NSAID相似，特别是水肿、血压升高、ACE抑制剂效应减弱，急性肾功能衰竭是一种慢性肾功能衰竭，是一种慢性肾功能衰竭。为了评估与非选择性NSAID对照药物相比，罗非昔布在OA患者中的肾血管安全性，方法：对IIb/III期OA临床试验中超过5000名参与者的肾血管不良事件（AE）进行了审查，并对罗非昔布和非选择性NSAID对照药物进行了比较结果：罗非昔布12.5 mg/天、罗非昔布25 mg/天和非选择性比较NSAID之间下肢水肿（LEE）AE的发生率基本相似。由于LEE AE和与LEE AE相关的具有临床意义的体重增加（大于或等于2 kg）导致的治疗中止不常见，并且在所有活性治疗组中基本相似。充血性心力衰竭（CHF）在所有治疗组中均罕见，高血压AE的发生率在所有活性治疗组中均较低。在所有治疗组中，因高血压AE和需要改变或调整血压药物的高血压AE导致的停药相似且不常见，仅报告1例急性肾衰竭（布洛芬治疗组）。结论：在罗非昔布IIb/III期OA数据库中，罗非昔布（一种选择性考克斯-2抑制剂）的肾脏安全性特征与对照药物基本相似，非选择性NSAIDs的研究。
Background: Non-selective non-steroidal antiinflammatory drugs (NSAIDs) inhibit both cyclooxygenase (COX) isoenzymes, i.e. COX-1 and COX-2. Rofecoxib, an agent that selectively Inhibits COX-2, has been shown to provide equivalent anti-inflammatory and analgesic efficacy to comparator non-selective NSAIDs in osteoarthritis (OA) and other pain models with a significant improvement in gastrointestinal (GI) safety and tolerability. Based on renal physiology studies, it was predicted that rofecoxib would have renovascular effects similar to those observed with non-selective NSAIDs specifically edema, blood pressure elevation, attenuation of the effects of ACE inhibitors, and (in rare circumstances), acute renal failure might be manifest in a small percentage of patients.Objective: To assess the renovascular safety profile of rofecoxib in OA patients compared to that of non-selective NSAID comparators,Methods: Renovascular adverse experiences (AEs) in over 5000 participants in Phase IIb/III OA clinical trials were reviewed and compared between rofecoxib and non-selective NSAID comparators (ibuprofen 800 mg lid, diclofenac 50 mg tid, nabumetone 1500 mg qd).Results:The incidence of lower extremity edema (LEE) AEs was generally similar between rofecoxib 12.5 mg/day, rofecoxib 25 mg/day, and non-selective comparator NSAIDs. Treatment discontinuations due to LEE AEs and clinically significant weight gain (greater than or equal to 2 kg) associated with LEE AEs were Infrequent and generally similar in all active treatment groups. Congestive heart failure (CHF) was rare in all treatment groups, The incidence of hypertension AEs was low in all active treatment groups. Discontinuations due to hypertension AEs and hypertension AEs requiring a change or adjustment in blood pressure medications were similar and uncommon in all treatment groups, There was only a single report of acute renal failure (in the ibuprofen treatment group).Conclusions: In the rofecoxib phase IIb/III OA database, the renal safety profile for rofecoxib, a selective inhibitor of COX-2, was generally similar to that of the comparator, non-selective NSAIDs which were studied.