Abstract

Introduction: Etripamil is a fast-acting, intranasally administered non-dihydropyridine, L-type calcium channel blocker in development for medically unsupervised self-administration to treat AV nodal-dependent paroxysmal supraventricular tachycardia (PSVT). The objective of this analysis was to compare patient-reported effectiveness and relief of symptoms for patients whose PSVT terminated (converters) versus non-converters within 10 and 30 minutes of etripamil treatment. Methods: NODE-301 (NCT03464019) is a randomized, double-blind, placebo-controlled phase 3 study. Patients self-administered the study drug (etripamil 70 mg) or placebo intranasally in response to a perceived SVT episode and were then monitored for 5 hours. Perceived treatment effectiveness was assessed via the Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9) effectiveness domain and patient-reported relief of symptoms was assessed by item 2. Converters and nonconverters were compared via 2-way ANOVA. Results: Of 107 patients who self-administered etripamil in response to a positively adjudicated SVT episode, 34 (32%) converted to sinus rhythm within 10 minutes, and 56 (54%) converted within 30 minutes. For both time points, converters had significantly higher mean TSQM domain scores for drug effectiveness and symptom relief compared with nonconverters ( Table ; P <0.001). Conclusion: Patients with PSVT who self-administered etripamil in response to an SVT episode reported higher effectiveness and better symptom relief when their episode was resolved within the first 10 and 30 minutes of the 5-hour monitoring period.

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