Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, 569-1094, Japan.
Vasc Health Risk Manag. 2024 Sep 2;20:415-420. doi: 10.2147/VHRM.S482190. eCollection 2024.
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.
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.
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).
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.
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.
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具有不同的代谢途径，但它们的不良事件（AE）谱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引起的不良反应，并评估其在自发报告数据库中的不良反应严重程度排序。
从日本药物不良反应报告数据库（JADER）中提取数据。分析与氯吡格雷和普拉格雷相关的 AE 报告，计算报告比值比（ROR）和 95%置信区间（CI）。
根据 5869 例氯吡格雷（69.6%，男性）和 513 例普拉格雷（74.1%，男性）的报告，分别确定了 703 和 135 种不同的 AE。出血并发症包括出血是氯吡格雷和普拉格雷共同常见的报告不良反应。对于与氯吡格雷相关的 AE，包括间质性肺病（227 例报告；ROR，1.77；95%CI，1.49-2.10）、肝功能异常（137 例报告；ROR，1.27；95%CI，1.07-1.51）和肝细胞损伤（96 例报告；ROR，120.0；95%CI，94.9-151.8）等意外 AE 的报告数量相对较高，这与普拉格雷不同。
本项对国家药物警戒数据库的分析突出了氯吡格雷和普拉格雷不同的 AE 特征。确定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。
