PIRTOBRUTINIB’S CARDIAC ADVERSE REACTIONS: AN EARLY PHARMACOVIGILANCE STUDY 

This poster presents an early retrospective pharmacovigilance analysis comparing cardiac adverse-event reports associated with pirtobrutinib and ibrutinib in the FDA Adverse Event Reporting System. Heart failure and atrial fibrillation were evaluated using reporting odds ratios, 95% confidence intervals, chi-square statistics, and p-values. Among 530 pirtobrutinib and 64,172 ibrutinib reports, pirtobrutinib showed significantly lower reporting odds for atrial fibrillation (ROR 0.33; 95% CI 0.15–0.69; p=0.002), suggesting a potentially more favorable arrhythmogenic profile. Heart failure reporting odds were numerically higher with pirtobrutinib but were not statistically significant (ROR 1.72; 95% CI 0.99–3.00; p=0.051). Close cardiac monitoring remains recommended until larger studies further clarify the cardiovascular safety of pirtobrutinib.