Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 72, Issue 5, Pages 489-497Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2018.04.082
Keywords
atrioventricular nodal re-entrant tachycardia; atrioventricular reciprocating tachycardia; calcium-channel blocker; conversion rate; episodic treatment; paroxysmal supraventricular tachycardia
Categories
Funding
- Milestone Pharmaceuticals
Ask authors/readers for more resources
BACKGROUND There is no nonparenteral medication for the rapid termination of paroxysmal supraventricular tachycardia. 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). 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. 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. 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) (C) 2018 Milestone Pharmaceuticals inc. Published by Elsevier on behalf of the American College of Cardiology Foundation.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available