Severe Adverse Cardiovascular Events Associated With Ibrutinib

Cardiovascular adverse drug reactions (CV-ADR) occur in association with ibrutinib, according to a study published in the issue of the Journal of the American College of Cardiology.

Joe-Elie Salem, M.D., Ph.D., from the Sorbonne Université in Paris, and colleagues examined and characterized CV-ADR associated with ibrutinib. A disproportionality analysis was performed using reported odds ratios (RORs) and an information component to determine whether CV-ADR and CV-ADR deaths correlated with ibrutinib.

The researchers identified 303 ibrutinib-associated cardiovascular deaths. There were correlations for ibrutinib with higher reporting of supraventricular arrhythmias (SVAs), central nervous system (CNS) hemorrhagic events, heart failure, ventricular arrhythmias, conduction disorders, CNS ischemic events, and hypertension (RORs, 23.1, 3.7, 3.5, 4.7, 3.5, 2.2, and 1.7, respectively). CV-ADR frequently occurred soon after administration of ibrutinib and correlated with fatalities ranging from about 10 to about 20 percent (SVAs and ventricular arrhythmias and CNS events, heart failure, and conduction disorders, respectively). Poor prognosis was seen when ibrutinib-associated SVA occurred concomitantly with CNS events, leading to 28.8 percent of deaths.

"In future clinical trials of ibrutinib, cardiovascular events should be carefully adjudicated so that patients at risk of these complications can be more accurately identified and preventive strategies can be developed," the authors write.

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