Association of Clopidogrel with Interstitial Lung Disease: Gaining Insight Through the Japanese Pharmacovigilance Database.

IF 2.6 Q2 PERIPHERAL VASCULAR DISEASE

Vascular Health and Risk Management Pub Date : 2024-09-02 eCollection Date: 2024-01-01 DOI:10.2147/VHRM.S482190

Mariko Kozaru, Hiroko Kambara, Akari Higuchi, Tatsuki Kagatsume, Keiko Hosohata

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引用次数: 0

Abstract

Background: The P2Y12 receptor inhibitors clopidogrel and prasugrel are widely used. Clopidogrel and prasugrel have different metabolic pathways, but whether their adverse event (AE) profiles differ significantly is unclear.

Objective: This study aimed to compare the possible AEs induced by clopidogrel and prasugrel and to assess the rank-order of their AEs submitted to a spontaneous reporting database.

Materials and methods: Data were extracted from the Japanese Adverse Drug Event Report database (JADER). Reports of AEs associated with clopidogrel and prasugrel were analyzed to calculate the reporting odds ratios (RORs) and 95% confidence intervals (CIs).

Results: Based on 5869 reports for clopidogrel (69.6%, men) and 513 reports for prasugrel (74.1%, men), 703 and 135 different AEs were identified, respectively. Bleeding complications including hemorrhage were commonly reported for both clopidogrel and prasugrel. As for AEs related to clopidogrel, unexpected AEs such as interstitial lung disease (227 reports; ROR, 1.77; 95% CI, 1.49-2.10), abnormal hepatic function (137 reports; ROR, 1.27; 95% CI, 1.07-1.51), and hepatocellular injury (96 reports; ROR, 120.0; 95% CI, 94.9-151.8) ranked at relatively high positions based on the number of occurrences, unlike prasugrel.

Conclusion: This analysis of the national pharmacovigilance database highlights distinct AE profiles for clopidogrel and prasugrel. Unexpected AEs associated with clopidogrel were identified, providing valuable insights for clinical monitoring and patient safety.

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氯吡格雷与间质性肺病的关系：从日本药物警戒数据库中获得启示

背景：P2Y12受体抑制剂氯吡格雷和普拉格雷被广泛使用。氯吡格雷和普拉格雷的代谢途径不同，但它们的不良反应（AE）是否有显著差异尚不清楚：本研究旨在比较氯吡格雷和普拉格雷可能诱发的不良反应，并评估向自发报告数据库提交的这两种药物不良反应的排序：数据来自日本药物不良事件报告数据库（JADER）。对与氯吡格雷和普拉格雷相关的不良反应报告进行分析，计算报告几率比（ROR）和95%置信区间（CI）：根据氯吡格雷的5869份报告（69.6%，男性）和普拉格雷的513份报告（74.1%，男性），分别发现了703种和135种不同的AE。包括出血在内的出血并发症是氯吡格雷和普拉格雷的常见并发症。至于与氯吡格雷相关的不良反应，与普拉格雷不同的是，间质性肺病（227份报告；ROR，1.77；95% CI，1.49-2.10）、肝功能异常（137份报告；ROR，1.27；95% CI，1.07-1.51）和肝细胞损伤（96份报告；ROR，120.0；95% CI，94.9-151.8）等意外不良反应根据发生次数排在相对靠前的位置：这项对国家药物警戒数据库的分析凸显了氯吡格雷和普拉格雷不同的AE特征。发现了与氯吡格雷相关的意外AE，为临床监测和患者安全提供了有价值的见解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vascular Health and Risk Management PERIPHERAL VASCULAR DISEASE-

CiteScore

4.20

自引率

3.40%

发文量

109

审稿时长

16 weeks

期刊介绍： An international, peer-reviewed journal of therapeutics and risk management, focusing on concise rapid reporting of clinical studies on the processes involved in the maintenance of vascular health; the monitoring, prevention, and treatment of vascular disease and its sequelae; and the involvement of metabolic disorders, particularly diabetes. In addition, the journal will also seek to define drug usage in terms of ultimate uptake and acceptance by the patient and healthcare professional.