coxibs和非甾体抗炎药新使用者的心血管结局:高危亚群和风险时间进程
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所罗门DH, Avorn J, Sturmer T, Glynn RJ, Mogun H, Schneeweiss S
coxibs和非甾体抗炎药新使用者的心血管结局:高危亚群和风险时间进程
关节炎。2006年5月;54(5):1378-89。
- PubMed ID
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16645966 (PubMed视图］
- 摘要
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目的:关于选择性环氧合酶2抑制剂(coxibs)和非选择性非甾体抗炎药(NSAIDs)治疗的心血管风险仍存在争议。本研究旨在对一大批新使用coxibs和NSAIDs的患者进行心血管事件的发生率、时间进程以及基线心血管风险是否会改变未来事件的发生率比(RRs)。方法:这项队列研究包括参加国家处方药计划的医疗保险受益人，该计划完全覆盖非甾体抗炎药和coxibs，不受限制。所有研究患者在1999年1月1日后开始使用coxib或NSAID。主要综合终点为心肌梗死或缺血性卒中入院。预定义暴露组包括在研究期间美国可用的3种coxib(塞来昔布、罗非昔布和valdecoxib)，以及口服双氯芬酸、布洛芬、萘普生和所有其他非甾体抗炎药的复合制剂。我们比较了与这些药物相关的心血管事件发生率与未使用非甾体抗炎药或coxibs，但开始使用与心血管风险无关的其他药物的参考组患者的发生率。根据处方数据评估所有研究药物的每日暴露量。Cox比例风险模型按历年分层，包括其他基线心血管危险因素构成主要分析。结果:我们确定了74,838名非甾体抗炎药或coxibs的使用者，23,532名其他药物的可比使用者组成了参照组。 Adjusted models demonstrated a significant elevation in the event rate for rofecoxib (RR 1.15, 95% confidence interval [95% CI] 1.06-1.25) and a significant reduction in the rate for naproxen (RR 0.75, 95% CI 0.62-0.92). No other coxib or NSAID was associated with a significant increase or decrease in cardiovascular event rate. The increased rate associated with rofecoxib was seen in the first 60 days of use (adjusted RR 1.14, 95% CI 1.01-1.29) and thereafter (adjusted RR 1.14, 95% CI 1.02-1.28). Kaplan-Meier event curves showed a similar pattern of risk (early and persistent separation of the event curves) among long-term rofecoxib users at low or high baseline cardiovascular risk. CONCLUSION: We found an increased cardiovascular event rate among users of rofecoxib, and a decreased rate with naproxen use. Other coxibs and NSAIDs did not appear to be associated with a difference in event rate compared with users of other drugs. The increase in rate associated with rofecoxib was seen within the first 60 days and persisted. There was no important modification of the event rate based on the patient's baseline cardiovascular risk.
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