2. Academic Validation
  3. Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm

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

  • J Am Coll Cardiol. 2018 Jul 31;72(5):489-497. doi: 10.1016/j.jacc.2018.04.082.
Bruce S Stambler 1,  Paul Dorian 2,  Philip T Sager 3,  Douglas Wight 4,  Philippe Douville 4,  Diane Potvin 5,  Pirouz Shamszad 6,  Ronald J Haberman 7,  Richard S Kuk 8,  Dhanunjaya R Lakkireddy 9,  Jose M Teixeira 10,  Kenneth C Bilchick 11,  Roger S Damle 12,  Robert C Bernstein 13,  Wilson W Lam 14,  Gearoid O'Neill 15,  Peter A Noseworthy 16,  Kalpathi L Venkatachalam 17,  Benoit Coutu 18,  Blandine Mondésert 19,  Francis Plat 20
Affiliations

Affiliations

  • 1 Piedmont Heart Institute, Atlanta, Georgia.
  • 2 University of Toronto & St. Michael's Hospital, Toronto, Ontario, Canada.
  • 3 Stanford University, Palo Alto, California.
  • 4 Milestone Pharmaceuticals, Montreal St.-Laurent, Quebec, Canada.
  • 5 Excelsus Statistics, Montreal, Quebec, Canada.
  • 6 Medpace, Cincinnati, Ohio.
  • 7 Top Line Pharma Contracting, Scottsdale, Arizona.
  • 8 Centra Stroobants Cardiovascular Center, Lynchburg, Virginia.
  • 9 University of Kansas Medical Center, Kansas City, Kansas.
  • 10 Black Hills Cardiovascular Research, Rapid City, South Dakota.
  • 11 University of Virginia Health System, Charlottesville, Virginia.
  • 12 South Denver Cardiology Associates, Littleton, Colorado.
  • 13 Sentara Norfolk General Hospital, Norfolk, Virginia.
  • 14 Baylor St. Luke's Medical Center, Houston, Texas.
  • 15 General Hospital, Sacramento, California.
  • 16 Mayo Clinic, Rochester, Minnesota.
  • 17 Mayo Clinic at Jacksonville, Jacksonville, Florida.
  • 18 Hotel-Dieu Recherche Cardiologie, Montreal, Quebec, Canada.
  • 19 Montreal Heart Institute, Montreal, Quebec, Canada.
  • 20 Milestone Pharmaceuticals, Montreal St.-Laurent, Quebec, Canada. Electronic address: [email protected].
PMID: 30049309 DOI: 10.1016/j.jacc.2018.04.082
Abstract

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).

Keywords

atrioventricular nodal re-entrant tachycardia; atrioventricular reciprocating tachycardia; calcium-channel blocker; conversion rate; episodic treatment; paroxysmal supraventricular tachycardia.

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