Is Gender Associated to Extended Cardiac Monitoring after First Dose of Fingolimod and Level of Satisfaction with the Monitoring Experience in Relapsing-Remitting Multiple Sclerosis Patients? A Post-hoc Analysis of the BEAT Study

Abstract

Objective: Fingolimod, a second-line therapy for relapsing-remitting multiple sclerosis, may cause transitory effects on heart rate and atrioventricular conduction that may result in bradycardia and atrioventricular blocks, mainly following first administration; an ECG monitoring for at least 6 hours is therefore recommended, to be extended in case of bradycardia. The BEAT study showed that the dominance of cardiac vagal modulation, though not representing a risk factor for rhythm complications, can help identifying patients with higher probability to require extended monitoring. Methods: This is a post-hoc analysis of the BEAT study, aimed at assessing the association between gender and need of extension of the ECG and gender differences in patients’ satisfaction with drug administration and monitoring experience. Results: Of the 625 patients evaluated in the BEAT study (67% were women), only 45 (7.2%; 95% CI: 5.3%; 9.5%) required an extended monitoring. Gender differences emerged in the assumption of drugs altering heart rate or atrioventricular conduction (6.4% of females vs. 0.5% of males, Chi-square test p-value=0.001) and in the sympathovagal balance status (median (interquartile range) RR LF/HF in women: 3.3 (1.3-7.4) respectively vs. 4.5 (2.1-10.2) in men, Wilcoxon test p-value=0.001). However, keeping constant the effect of these variables, no association emerged between sex and early ECG abnormalities requiring a prolongation of post-first dose monitoring. Our specifically developed satisfaction score showed a higher level of satisfaction with the overall care experience in women than in men (beta female vs. male=1.69 points) and women perceived a greater favorable impact of the drug on their daily living than man (median of ‘impact of treatment’ item in males and females 7.0 and 2.0, respectively, Wilcoxon test p-value=0.005). Conclusion: No association emerged between sex and early ECG response to fingolimod administration requiring extended cardiac monitoring. More women than men reported a higher level of satisfaction with drug administration and monitoring procedures.