| アブストラクト | Background Self-administration of investigational intranasal L-type calcium channel blocker etripamil during paroxysmal supraventricular tachycardia (PSVT) appeared safe and well-tolerated in the phase 3 NODE-301 (Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia) trial of adults with sustained atrioventricular nodal-dependent PSVT. The NODE-302 open-label extension further characterized etripamil safety and efficacy. Methods and Results Eligible patients were monitored via self-applied cardiac monitoring system for 5 hours after etripamil self-administration. The primary end point was time-to-conversion of positively adjudicated PSVT to sinus rhythm after etripamil treatment. Probability of conversion to sinus rhythm was reported via Kaplan-Meier plot. Adverse events were based on self-reported symptoms and clinical evaluations. Among 169 patients enrolled, 105 self-administered etripamil >/=1 time for perceived PSVT (median [range], 232 [8-584] days' follow-up). Probability of conversion within 30 minutes of etripamil was 60.2% (median time to conversion, 15.5 minutes) among 188 PSVT episodes (92 patients) positively adjudicated as atrioventricular nodal dependent by independent ECG analysis. Among 40 patients who self-treated 2 episodes, 75% had a significantly consistent response by 30 minutes; 9 did not convert on either episode, and 21 converted on both episodes (chi(2)=8.09; P=0.0045). Forty-five of 105 patients (42.9%) had >/=1 treatment-emergent adverse event, generally transient and mild-to-moderate, including nasal congestion (14.3%), nasal discomfort (14.3%), or rhinorrhea (12.4%). No serious cardiac safety events were observed within 24 hours of etripamil. Conclusions In this extension study, investigational etripamil nasal spray was well tolerated for self-treating recurrent episodes of PSVT without medical supervision. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03635996. |
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| ジャーナル名 | Journal of the American Heart Association |
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| 投稿日 | 2023/9/27 |
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| 投稿者 | Ip, James E; Coutu, Benoit; Bennett, Matthew T; Pandey, A Shekhar; Stambler, Bruce S; Sager, Philip; Chen, Michael; Shardonofsky, Silvia; Plat, Francis; Camm, A John |
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| 組織名 | Weill Cornell Medicine, New York-Presbyterian Hospital New York NY USA.;Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada.;Centre for Cardiovascular Innovation Division of Cardiology University of British;Columbia Vancouver British Columbia Canada.;Cambridge Cardiac Care Centre Cambridge Ontario Canada.;Piedmont Heart Institute Atlanta GA USA.;Cardiovascular Research Institute and Department of Medicine Stanford University;Palo Alto CA USA.;TCM Groups, Inc Berkeley Heights NJ USA.;Milestone Pharmaceuticals Montreal Quebec Canada.;St. George's University of London London United Kingdom. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37753718/ |
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