TY - JOUR
T1 - Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm
AU - Stambler, Bruce S.
AU - Dorian, Paul
AU - Sager, Philip T.
AU - Wight, Douglas
AU - Douville, Philippe
AU - Potvin, Diane
AU - Shamszad, Pirouz
AU - Haberman, Ronald J.
AU - Kuk, Richard S.
AU - Lakkireddy, Dhanunjaya R.
AU - Teixeira, Jose M.
AU - Bilchick, Kenneth C.
AU - Damle, Roger S.
AU - Bernstein, Robert C.
AU - Lam, Wilson W.
AU - O'Neill, Gearoid
AU - Noseworthy, Peter A.
AU - Venkatachalam, Kalpathi L.
AU - Coutu, Benoit
AU - Mondésert, Blandine
AU - Plat, Francis
N1 - Publisher Copyright:
© 2018 Milestone Pharmaceuticals Inc.
PY - 2018/7/31
Y1 - 2018/7/31
N2 - 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.
AB - 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.
KW - atrioventricular nodal re-entrant tachycardia
KW - atrioventricular reciprocating tachycardia
KW - calcium-channel blocker
KW - conversion rate
KW - episodic treatment
KW - paroxysmal supraventricular tachycardia
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U2 - 10.1016/j.jacc.2018.04.082
DO - 10.1016/j.jacc.2018.04.082
M3 - Article
C2 - 30049309
AN - SCOPUS:85049898204
SN - 0735-1097
VL - 72
SP - 489
EP - 497
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 5
ER -