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Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm.
- 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.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Dose-Response Relationship, Drug
Double-Blind Method
Female
Follow-Up Studies
Heart Rate physiology
Humans
Male
Middle Aged
Tachycardia, Supraventricular physiopathology
Time Factors
Calcium Channel Blockers administration & dosage
Heart Rate drug effects
Nasal Sprays
Tachycardia, Supraventricular diagnosis
Tachycardia, Supraventricular drug therapy
Subjects
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