Key result
Ticagrelor is linked to ~2.3-fold higher AKI reporting vs. clopidogrel in older adults.
Why the study?
Despite widespread use of ticagrelor in patients aged ≥75 years with acute coronary syndromes, data on its safety in older adults remain limited.
Does ticagrelor alter the reporting profile of major adverse events compared to clopidogrel in older adults?
Observational (n=21,166)
Does ticagrelor alter the reporting profile of major adverse events compared to clopidogrel in older adults?
Odds Ratio: 2.31 (95% CI 1.46–3.64)
Absolute Event Rate: 1.78% vs 0.78%
p-value: p=<0.001
This pharmacovigilance analysis suggests ticagrelor is generally safe in older adults without excess reporting of bleeding or dyspnea compared to clopidogrel, but highlights a potential need to monitor renal function due to increased reporting of acute kidney injury.
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. Material & methods We performed a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) 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 (CI) were calculated, and differences between age groups were evaluated 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. Keywords ACS, anti-platelets, Ticagrelor, elderly, adverse effect
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Yacoby-Halevi et al. (2026) conducted an observational in Acute coronary syndromes (FAERS reports) (n=21,166). Ticagrelor vs. Clopidogrel was evaluated on Acute kidney injury reporting in older adults (≥75 years) (ROR 2.31, 95% CI 1.46-3.64, p=<0.001). In older adults aged ≥75 years, ticagrelor was associated with increased reporting of acute kidney injury compared to clopidogrel (ROR 2.31), without an increase in other major adverse events.
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