Clinical Pharmacology and Pharmacoepidemiology, Utrecht Institute of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
Department of Healthcare Development, Stockholm Region Public Healthcare Services Committee, Stockholm, Sweden.
Heart. 2022 Apr;108(8):613-618. doi: 10.1136/heartjnl-2021-319332. Epub 2021 Aug 2.
To evaluate if proton pump inhibitor (PPI) treatment reduces the risk of upper gastrointestinal bleeding (UGIB) in patients with atrial fibrillation (AF) treated with non-vitamin K antagonist oral anticoagulants (NOACs).
We used a common protocol, common data model approach to conduct a cohort study including patients with AF initiated on a NOAC in Stockholm, Denmark and the Netherlands from April 2011 until July 2018. The outcome of interest was a UGIB diagnosed in a secondary care inpatient setting. We used an inverse probability weighted (IPW) Poisson regression to calculate incidence rate ratios (IRRs), contrasting PPI use to no PPI use periods.
In 164 290 NOAC users with AF, providing 272 570 years of follow-up and 39 938 years of PPI exposure, 806 patients suffered a UGIB. After IPW, PPI use was associated with lower UGIB rates (IRR: 0.75; 95% CI: 0.59 to 0.95). On an absolute scale, the protective effect was modest, and was found to be largest in high-risk patients, classified as age 75-84 years (number needed to treat for 1 year (NNTY): 787), age ≥85 years (NNTY: 667), HAS-BLED score ≥3 (NNTY: 378) or on concomitant antiplatelet therapy (NNTY: 373).
Concomitant treatment with a PPI in NOAC-treated patients with AF is associated with a reduced risk of severe UGIB. This indicates that PPI cotreatment can be considered, in particular among the elderly patients, patients with a HAS-BLED score ≥3, and/or in patients on concomitant antiplatelet therapy.
评估质子泵抑制剂 (PPI) 治疗是否降低了使用非维生素 K 拮抗剂口服抗凝剂 (NOAC) 治疗的心房颤动 (AF) 患者上消化道出血 (UGIB) 的风险。
我们使用通用方案和通用数据模型方法，开展了一项队列研究，纳入了 2011 年 4 月至 2018 年 7 月在丹麦斯德哥尔摩和荷兰接受 NOAC 治疗的 AF 患者。主要结局为二级护理住院患者中诊断的 UGIB。我们使用逆概率加权 (IPW) 泊松回归计算发病率比 (IRR)，对比 PPI 用药期和非 PPI 用药期。
在 164290 例使用 NOAC 的 AF 患者中，提供了 272570 年的随访和 39938 年的 PPI 暴露，806 例患者发生了 UGIB。经 IPW 校正后，PPI 用药与 UGIB 发生率较低相关 (IRR：0.75；95%CI：0.59 至 0.95)。从绝对规模来看，这种保护作用较小，在高危患者中效果最大，这些患者年龄为 75-84 岁 (1 年所需治疗人数 (NNTY)：787)、年龄≥85 岁 (NNTY：667)、HAS-BLED 评分≥3 (NNTY：378) 或同时接受抗血小板治疗 (NNTY：373)。
在接受 AF 治疗的 NOAC 患者中，同时使用 PPI 与严重 UGIB 风险降低相关。这表明在老年患者、HAS-BLED 评分≥3 的患者和/或同时接受抗血小板治疗的患者中，可以考虑同时使用 PPI 治疗。
