选择性环氧化酶-2抑制与心血管效应：一项针对医疗补助计划人群的观察性研究。

Selective cyclooxygenase-2 inhibition and cardiovascular effects: an observational study of a Medicaid population.

作者信息

Shaya Fadia T, Blume Steven W, Blanchette Christopher M, Weir Matthew R, Mullins C Daniel

机构信息

Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.

出版信息

Arch Intern Med. 2005 Jan 24;165(2):181-6. doi: 10.1001/archinte.165.2.181.

DOI:10.1001/archinte.165.2.181

PMID:15668364

Abstract

BACKGROUND

The differential effects of selective cyclooxygenase-2 (COX-2) inhibitors compared with nonspecific nonsteroidal anti-inflammatory agents (NSAIDs) on platelet aggregation and prostacyclin/thromboxane balance have led to concerns that COX-2 inhibitors may increase the risk for cardiovascular thrombotic events. Empirical studies have generally been limited to analyses of secondary end points with low event rates in clinical trials and single event rates in observational studies, all of which have come to conflicting conclusions. This observational cohort study examines the cardiovascular risk of COX-2 inhibitors compared with nonspecific NSAIDs in Maryland Medicaid enrollees, a high-risk population.

METHODS

Medical and prescription claims were analyzed for noninstitutionalized Medicaid enrollees who received at least a 60-day supply of a COX-2 inhibitor or other prescription NSAID between June 2000 and June 2002 and who did not use these drugs for at least 6 months prior. Naproxen users were excluded. We developed a logistic model of propensity for treatment with COX-2 inhibitors and stratified patients by quintiles of their propensity score. The model adjusted for demographics, indications for COX-2 inhibitors, and cardiovascular risk factors.

RESULTS

The study population comprised 1005 patients using COX-2 inhibitors and 5245 patients using a nonnaproxen NSAID. Of the 6250 patients, 70% were female, 50% were African American, and 30% were older than 50 years. Overall, 12% of the patients had at least 1 cardiovascular thrombotic event after treatment within the follow-up period. The propensity-adjusted odds ratio showed no significant effect of COX-2 inhibitor use on this percentage of patients (odds ratio, 1.09; 95% confidence interval, 0.90-1.33).

CONCLUSION

We did not find that COX-2 inhibitors increased cardiovascular risk over nonnaproxen NSAIDs in a high-risk Medicaid population.

摘要

背景

与非特异性非甾体抗炎药（NSAIDs）相比，选择性环氧化酶-2（COX-2）抑制剂对血小板聚集和前列环素/血栓素平衡的不同影响引发了人们对COX-2抑制剂可能增加心血管血栓事件风险的担忧。实证研究通常局限于对临床试验中低事件发生率的次要终点以及观察性研究中的单一事件发生率进行分析，所有这些研究都得出了相互矛盾的结论。这项观察性队列研究在高危人群马里兰州医疗补助计划参保者中，考察了COX-2抑制剂与非特异性NSAIDs相比的心血管风险。

方法

对2000年6月至2002年6月期间接受至少60天剂量COX-2抑制剂或其他处方NSAIDs且在此之前至少6个月未使用这些药物的非机构化医疗补助计划参保者的医疗和处方申请进行分析。排除使用萘普生的患者。我们建立了一个使用COX-2抑制剂治疗倾向的逻辑模型，并根据患者倾向得分的五分位数对患者进行分层。该模型对人口统计学、COX-2抑制剂的适应症和心血管危险因素进行了调整。

结果

研究人群包括1005名使用COX-2抑制剂的患者和5245名使用非萘普生NSAIDs的患者。在这6250名患者中，70%为女性，50%为非裔美国人，30%年龄超过50岁。总体而言，12%的患者在随访期内治疗后至少发生1次心血管血栓事件。倾向调整后的比值比显示，使用COX-2抑制剂对这一患者比例没有显著影响（比值比，1.09；95%置信区间，0.90 - 1.33）。