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Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm.

Authors :
Stambler BS
Dorian P
Sager PT
Wight D
Douville P
Potvin D
Shamszad P
Haberman RJ
Kuk RS
Lakkireddy DR
Teixeira JM
Bilchick KC
Damle RS
Bernstein RC
Lam WW
O'Neill G
Noseworthy PA
Venkatachalam KL
Coutu B
Mondésert B
Plat F
Source :
Journal of the American College of Cardiology [J Am Coll Cardiol] 2018 Jul 31; Vol. 72 (5), pp. 489-497.
Publication Year :
2018

Abstract

Background: There is no nonparenteral medication for the rapid termination of paroxysmal supraventricular tachycardia.<br />Objectives: The purpose of this study was to assess the efficacy and safety of etripamil nasal spray, a short-acting calcium-channel blocker, for the rapid termination of paroxysmal supraventricular tachycardia (SVT).<br />Methods: This phase 2 study was performed during electrophysiological testing in patients with previously documented SVT who were induced into SVT prior to undergoing a catheter ablation. Patients in sustained SVT for 5 min received either placebo or 1 of 4 doses of active compound. The primary endpoint was the SVT conversion rate within 15 min of study drug administration. Secondary endpoints included time to conversion and adverse events.<br />Results: One hundred four patients were dosed. Conversion rates from SVT to sinus rhythm were between 65% and 95% in the etripamil nasal spray groups and 35% in the placebo group; the differences were statistically significant (Pearson chi-square test) in the 3 highest active compound dose groups versus placebo. In patients who converted, the median time to conversion with etripamil was <3 min. Adverse events were mostly related to the intranasal route of administration or local irritation. Reductions in blood pressure occurred predominantly in the highest etripamil dose.<br />Conclusions: Etripamil nasal spray rapidly terminated induced SVT with a high conversion rate. The safety and efficacy results of this study provide guidance for etripamil dose selection for future studies involving self-administration of this new intranasal calcium-channel blocker in a real-world setting for the termination of SVT. (Efficacy and Safety of Intranasal MSP-2017 [Etripamil] for the Conversion of PSVT to Sinus Rhythm [NODE-1]; NCT02296190).<br /> (Copyright © 2018 Milestone Pharmaceuticals Inc. Published by Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1558-3597
Volume :
72
Issue :
5
Database :
MEDLINE
Journal :
Journal of the American College of Cardiology
Publication Type :
Academic Journal
Accession number :
30049309
Full Text :
https://doi.org/10.1016/j.jacc.2018.04.082