Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs.
Clopidogrel and interaction with proton pump inhibitors: comparison between cohort and within person study designs.
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DOI：
10.1136/bmj.e4388
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发表时间：
2012-07-10
期刊：
影响因子：
--
通讯作者：
Smeeth L
中科院分区：
文献类型：
--
作者：
Douglas IJ;Evans SJ;Hingorani AD;Grosso AM;Timmis A;Hemingway H;Smeeth L
目的 测量质子泵抑制剂的使用与使用氯吡格雷和阿司匹林的患者的一系列有害结果之间的关联。设计观察性队列研究和自我对照病例系列。使用来自心肌缺血国家审计项目 (MINAP) 和国家统计办公室的链接数据（使用链接的定制研究和电子记录 (CALIBRE) 协作进行心血管疾病研究）设置英国全科医学研究数据库 24 471 名接受氯吡格雷和阿司匹林治疗的患者。主要结局指标 主要结局是死亡或心肌梗塞事件。次要结局是死亡、心肌梗死、血管性死亡和非血管性死亡。对使用和不使用质子泵抑制剂进行了比较。结果 在 24 471 名服用氯吡格雷和阿司匹林的患者中，12 439 名患者 (50%) 在研究期间的某个时间还服用了质子泵抑制剂。接受质子泵抑制剂治疗的患者中有 1419 名 (11%) 发生死亡或心肌梗塞，而未接受质子泵抑制剂的患者有 1341 名 (8%) 发生死亡或心肌梗塞。在多变量分析中，质子泵抑制剂的使用与死亡或心肌梗死事件之间关联的风险比为 1.37（95% 置信区间为 1.27 至 1.48）。次要结局以及其他 2C19 抑制剂和非 2C19 抑制剂的结果具有可比性。通过自我对照病例系列设计消除人与人之间差异的影响，质子泵抑制剂的使用与心肌梗死之间没有关联，比率为0.75（0.55至1.01）。同样，在自我对照病例系列中，其他 2C19 抑制剂/非抑制剂与心肌梗死没有关联。结论 缺乏特定关联以及人与人之间和人内部分析结果之间的差异表明质子泵抑制剂和氯吡格雷之间的相互作用在临床上并不重要。
Objective To measure the association between use of proton pump inhibitors and a range of harmful outcomes in patients using clopidogrel and aspirin. Design Observational cohort study and self controlled case series. Setting United Kingdom General Practice Research Database with linked data from the Myocardial Ischaemia National Audit Project (MINAP) and the Office for National Statistics (the cardiovascular disease research using linked bespoke studies and electronic records (CALIBER) collaboration) Population 24 471 patients receiving clopidogrel and aspirin. Main outcome measures The primary outcome was death or incident myocardial infarction. Secondary outcomes were death, incident myocardial infarction, vascular death, and non-vascular death. Comparisons were made between proton pump inhibitor use and non-use. Results Of the 24 471 patients prescribed clopidogrel and aspirin, 12 439 (50%) were also prescribed a proton pump inhibitor at some time during the study. Death or incident myocardial infarction occurred in 1419 (11%) patients while they were receiving a proton pump inhibitor compared with 1341 (8%) who were not receiving a proton pump inhibitor. In multivariate analysis, the hazard ratio for the association between proton pump inhibitor use and death or incident myocardial infarction was 1.37 (95% confidence interval 1.27 to 1.48). Comparable results were seen for secondary outcomes and with other 2C19 inhibitors and with non-2C19 inhibitors. With the self controlled case series design to remove the effect of differences between people, there was no association between proton pump inhibitor use and myocardial infarction, with a rate ratio of 0.75 (0.55 to 1.01). Similarly, with the self controlled case series there was no association with myocardial infarction for other 2C19 inhibitors/non-inhibitors. Conclusion The lack of a specific association and the discrepancy between findings of the analyses between and within people suggests that the interaction between proton pump inhibitors and clopidogrel is clinically unimportant.
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