Key result
Concurrent use of rivaroxaban and verapamil in patients ≥80 years with atrial fibrillation increased clinically relevant non-major bleeding compared to rivaroxaban alone (34% vs 13%, p<0.05).
Why the study?
Peculiarities of the drug-drug interaction between rivaroxaban and calcium channel blockers (verapamil and amlodipine) in patients aged 80 years and older with nonvalvular atrial fibrillation needed to be evaluated.
Does the combination of rivaroxaban and calcium channel blockers increase rivaroxaban concentration and bleeding risk in patients aged 80 years and older with nonvalvular atrial fibrillation?
Observational (n=128)
Does the combination of rivaroxaban and calcium channel blockers increase rivaroxaban concentration and bleeding risk in patients aged 80 years and older with nonvalvular atrial fibrillation?
Absolute Event Rate: 34% vs 13%
p-value: p=<0.05
In octogenarians with nonvalvular atrial fibrillation, combining rivaroxaban with verapamil, but not amlodipine, significantly increases rivaroxaban plasma concentrations and the risk of clinically relevant non-major bleeding.
May warrant caution with rivaroxaban-verapamil in octogenarians with AF; leaves open need for prospective confirmation.
Objectives For revealing the peculiarities of the drug–drug interaction of rivaroxaban (substrate CYP3A4 and P-gp) and calcium channel blockers (CCBs) (verapamil – inhibitor CYP3A4 and P-gp and amlodipine – substrate CYP3A4) in patients 80 years and older with nonvalvular atrial fibrillation (NAF) we studied 128 patients. Methods All patients were divided into groups depending on the therapy taken: the 1st – rivaroxaban + amlodipine (n=51), the 2nd – rivaroxaban + verapamil (n=30), the control group – rivaroxaban without CCBs (n=47). A trough steady-state plasma concentration ( C min,ss ) of rivaroxaban, prothrombin time (PT) in the blood plasma and the event of clinically relevant non-major (CRNM) bleeding were assessed for each patient. Results Patient in group 2 had higher C min,ss of rivaroxaban, PT and CRNM than subjects in the control group (Me 73.8 [50.6–108.8] ng/mL vs. 40.5 [25.6–74.3] ng/mL; Me 14.8 [13.4–17.3] s vs. 13.8 [12.6–14.4] s; 34% vs. 13%, respectively, p<0.05 for all). When compared, the PT and complication rate in group 1 with the control group C min,ss of rivaroxaban were practically the same (p>0.05 for all). Conclusions In patients ≥80 years with NAF, the use of rivaroxaban in combination with verapamil may not be safe and can lead to CRNM bleeding.
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Сычев et al. (2020) conducted an observational in nonvalvular atrial fibrillation (n=128). Rivaroxaban + verapamil vs. Rivaroxaban without calcium channel blockers was evaluated on Clinically relevant non-major (CRNM) bleeding (p=<0.05). Concurrent use of rivaroxaban and verapamil in patients ≥80 years with atrial fibrillation increased clinically relevant non-major bleeding compared to rivaroxaban alone (34% vs 13%, p<0.05).
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