Department of Neurology, Chonnam National University Hospital, Gwangju, Korea.
Hanmi Pharmaceutical Co., Ltd., Seoul, Korea.
Medicine (Baltimore). 2024 Mar 1;103(9):e37205. doi: 10.1097/MD.0000000000037205.
Dual antiplatelet therapy (DAPT) with the combination of clopidogrel and aspirin is recommended for preventing secondary ischemic events in patients with acute coronary syndrome (ACS) or acute ischemic stroke (AIS). Proton pump inhibitors (PPIs) are suggested as preventive treatment for these patients. Due to clopidogrel-PPI interactions, separating their administration might be considered. However, a paucity of studies has been conducted to investigate the outcome differences between concurrent and interval-based use in ACS and AIS patients. Our study aimed to evaluate clinical outcomes based on administration timing. This study included patients with ACS or AIS onset or recurrence of within the last month. Patients who were expected to receive DAPT for at least 6 months and who were currently taking or planning to take esomeprazole were included. Patients were divided into Group 1 (interval administration group, IA group) and Group 2 (concurrent administration group, CA group) according to the interval between esomeprazole and DAPT administration. The time interval was based on 12 hours. The primary outcome was the occurrence of major adverse cardiocerebrovascular events (MACCEs), and safety outcomes were defined as major bleeding, minor bleeding and gastrointestinal bleeding and intracranial hemorrhage. A total of 3600 patients completed this study. The proportions of patients in the 2 groups were as follows: CA group, 99% (n = 3489) and IA group, 1% (n = 111). The primary outcome occurred in 0.9% of patients in the IA group and 1.8% of patients in the CA group (P = .51). There was no significant distinction in the overall bleeding risk of the CA group compared to that of the IA group (2.75% in the CA group and 2.70% in the IA group). Additionally, there was no significant difference observed between the 2 groups for safety outcomes. This multicenter, prospective, observational study that enrolled patients with ACS or AIS demonstrated that there was no significant difference in the occurrence of MACCEs and bleeding issues within 6 months according to the medication administration interval. The majority of patients with DAPT were taking PPIs simultaneously in real-world practice.
双联抗血小板治疗（DAPT）联合氯吡格雷和阿司匹林推荐用于预防急性冠脉综合征（ACS）或急性缺血性脑卒中（AIS）患者的二次缺血事件。质子泵抑制剂（PPIs）被建议作为这些患者的预防治疗药物。由于氯吡格雷和 PPI 之间存在相互作用，可能需要分开使用。然而，关于 ACS 和 AIS 患者中同时使用和基于时间间隔使用的结局差异，研究相对较少。本研究旨在根据给药时间评估临床结局。本研究纳入了 ACS 或 AIS 发病或复发时间在过去 1 个月内的患者。预计至少接受 6 个月 DAPT 治疗且正在服用或计划服用埃索美拉唑的患者纳入研究。根据埃索美拉唑和 DAPT 给药之间的时间间隔，患者被分为 1 组（间隔给药组，IA 组）和 2 组（同时给药组，CA 组）。时间间隔为 12 小时。主要结局是主要不良心脑血管事件（MACCEs）的发生，安全性结局定义为大出血、小出血和胃肠道出血及颅内出血。共有 3600 名患者完成了这项研究。2 组患者的比例如下：CA 组 99%（n=3489）和 IA 组 1%（n=111）。IA 组患者的主要结局发生率为 0.9%，CA 组患者的发生率为 1.8%（P=0.51）。CA 组的总体出血风险与 IA 组相比没有显著差异（CA 组为 2.75%，IA 组为 2.70%）。此外，2 组间安全性结局也没有显著差异。这项多中心、前瞻性、观察性研究纳入了 ACS 或 AIS 患者，结果显示，根据药物给药间隔，6 个月内 MACCEs 和出血问题的发生没有显著差异。在真实世界实践中，大多数接受 DAPT 的患者同时服用 PPI。
