Comparison of thromboembolic events in patients treated with Celecoxib, a cyclooxygenase-1 specific inhibitor, versus Ibuprofen or Diclofenac
Comparison of thromboembolic events in patients treated with Celecoxib, a cyclooxygenase-1 specific inhibitor, versus Ibuprofen or Diclofenac
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DOI：
10.1016/s0002-9149(01)02265-2
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发表时间：
2002-02-15
影响因子：
2.8
通讯作者：
Lefkowith, JB
中科院分区：
文献类型：
--
作者：
White, WB;Faich, G;Lefkowith, JB
有人假设，环氧合酶2特异性抑制剂可能会增加心血管（CV）血栓栓塞事件的风险，因为它们抑制血管前列环素的合成，对血小板血栓素A（2）的产生和聚集缺乏影响。因此，我们分析了塞来昔布长期关节炎安全性研究中塞来昔布和非甾体抗炎药（NSAID）的数据，以确定严重CV血栓栓塞事件的发生率。该试验包括3，987例随机分配至塞来昔布400 mg每日2次组（2，320人-年暴露量）和3，981例随机分配至布洛芬800 mg每日3次组或双氯芬酸75 mg每日2次组（2，203人-年）。由于允许使用乙酰水杨酸（阿萨）预防CV风险（小于或等于325 mg/天），因此对所有患者和未使用阿萨的患者进行单独分析。对于所有患者以及未服用阿萨的患者亚组，塞来昔布和NSAID对照药物（联合或单独）之间严重CV血栓栓塞事件（心肌梗死、卒中、CV死亡和外周事件）的发生率相似，且无显著差异。所有严重CV血栓栓塞事件以及个体事件均如此。心肌梗死的发生率没有明显增加，即使在未服用阿萨的心肌梗死二级预防候选患者中也是如此。塞来昔布与NSAID相比，所有患者发生严重CV血栓栓塞事件的相对风险为1.1，未服用阿萨的患者亚组为1.1（95%置信区间分别为0.7 - 1.6和0.6 - 1.9）。此外，无论是否使用阿萨，高血压、水肿和充血性心力衰竭等心血管不良事件的发生率均与NSAID对照药物相似或显著低于NSAID对照药物。因此，这些分析表明，与传统NSAID相比，塞来昔布未增加严重CV血栓栓塞事件的风险，因此不支持环加氧酶2特异性抑制剂对CV系统的一类不良反应的假设。(C)2002年，Excerpta Medica，Inc.
It has been hypothesized that cyclooxgenase 2 specific inhibitors may increase the risk of cardiovascular (CV) thromboembolic events because of their inhibition of vascular prostacyclin synthesis and lack of an effect on platelet thromboxane A(2) production and aggregation. Thus, we analyzed the data for celecoxib and nonsteroidal anti-inflammatory drugs (NSAIDs) from the Celecoxib Long-term Arthritis Safety Study to determine the incidences of serious CV thromboembolic events. This trial included 3,987 persons randomized to celecoxib 400 mg twice daily (2,320 person-years of exposure) and 3,981 persons randomized to either ibuprofen 800 mg 3 times daily or diclofenac 75 mg twice daily (2,203 person-years). Because acetylsalicylic acid (ASA) use for CV risk prophylaxis (less than or equal to325 mg/day) was permitted, separate analyses were performed for all patients and those not taking ASA. The incidences of serious CV thromboembolic events (myocardial infarction, stroke, CV deaths, and peripheral events) were similar, and not significantly different, between celecoxib and NSAID comparators (combined or individually) for all patients as well as the subgroup of patients not taking ASA. This observation was true both for all serious CV thromboembolic events, as well as for individual events. No increase in myocardial infarction was apparent, even in patients not taking ASA who were candidates for secondary prophylaxis for myocardial infarction. The relative risks for celecoxib versus NSAIDs for serious CV thromboembolic events were 1.1 for all patients and 1.1 for the subgroup of patients not taking ASA (95% confidence interval 0.7 to 1.6 and 0.6 to 1.9, respectively). In addition, the incidences of adverse CV events such as hypertension, edema, and congestive heart failure were similar to, or significantly lower than, NSAID comparators regardless of the use of ASA. Thus, these analyses demonstrate no increased risk of serious CV thromboembolic events associated with celecoxib compared with conventional NSAIDs and therefore do not support the hypothesis of a class adverse effect of cyclooxgenase 2 specific inhibitors on the CV system. (C) 2002 by Excerpta Medica, Inc.