The Safety Profile of Ticagrelor among Older Adults (Age ≥75 years): A Pharmacovigilance Analysis.

IF 1.9 4区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiology Pub Date : 2026-06-09 DOI:10.1159/000552641

Inbar Yacoby-Halevi, Boris Kruchin, Chen Gadot, Dmitri Guz, Assaf Rotmensh, Yonatan Shaleve, Hila Sharon, Noam Greenberg, Boris Fishman, Edward Itelman, Aviad Rotholz, Keren Skalsky, Katia Orvin, Alon Eisen, Ran Kornowski, Tsahi T Lerman, Amos Levi

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引用次数: 0

Abstract

Introduction: Ticagrelor is a widely used potent P2Y12 inhibitor in patients aged ≥75 years with acute coronary syndromes. Despite its widespread use, data on ticagrelor's safety in older adults remain limited.

Methods: We performed a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System from 2010 to 2024. Disproportionality analysis compared ticagrelor with clopidogrel, assessing predefined adverse events in adults (<75 years) and older adults (≥75 years). For each group, reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated, and differences between age groups were evaluated using interaction analysis.

Results: A total of 6,476 ticagrelor-related adverse event reports were included: 4,795 (74%) adults and 1,681 (26%) older adults. In older adults, ticagrelor was not associated with increased reporting of dyspnea, intracranial hemorrhage, complete atrioventricular block, or gout. Acute kidney injury (AKI) was the only event reported more frequently in older adults (ROR 2.3 [95% CI: 1.5-3.6] vs. 0.6 [95% CI: 0.4-0.9]; p < 0.001). Ticagrelor was associated with lower reporting of gastrointestinal bleeding, hematuria, hemoptysis, and anemia in both age subgroups. Bradycardia and syncope were reported more frequently among adults (p = 0.002 and p < 0.001, respectively).

Conclusion: Ticagrelor appears generally safe in older adults (≥75 years), with no excess reporting of major adverse events compared to younger adults, aside from a higher reporting of AKI.

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替格瑞洛在老年人（≥75岁）中的安全性：药物警戒分析

替格瑞洛是一种广泛应用于75岁以上急性冠脉综合征患者的强效P2Y12抑制剂。尽管它被广泛使用，但关于替格瑞洛在老年人中的安全性的数据仍然有限。材料与方法我们使用FDA不良事件报告系统（FAERS）进行了2010年至2024年的回顾性药物警戒分析。对替格瑞洛和氯吡格雷进行歧化分析，评估成人预先确定的不良事件(

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

Cardiology 医学-心血管系统

CiteScore

3.40

自引率

5.30%

发文量

审稿时长

1.5 months

期刊介绍： ''Cardiology'' features first reports on original clinical, preclinical and fundamental research as well as ''Novel Insights from Clinical Experience'' and topical comprehensive reviews in selected areas of cardiovascular disease. ''Editorial Comments'' provide a critical but positive evaluation of a recent article. Papers not only describe but offer critical appraisals of new developments in non-invasive and invasive diagnostic methods and in pharmacologic, nutritional and mechanical/surgical therapies. Readers are thus kept informed of current strategies in the prevention, recognition and treatment of heart disease. Special sections in a variety of subspecialty areas reinforce the journal''s value as a complete record of recent progress for all cardiologists, internists, cardiac surgeons, clinical physiologists, pharmacologists and professionals in other areas of medicine interested in current activity in cardiovascular diseases.