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Etripamil Nasal Spray for Recurrent Paroxysmal Supraventricular Tachycardia Conversion: Results From the NODE-303
James E Ip1, Benoit Coutu2, John H Ip3
1New York Presbyterian Hospital, Weill Cornell Medicine, New York, USA.
Etripamil nasal spray effectively and safely terminated paroxysmal supraventricular tachycardia (PSVT) episodes at home. This study confirmed its real-world utility for self-administered PSVT treatment without a prior supervised dose.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Etripamil is a novel intranasal calcium-channel blocker designed for rapid paroxysmal supraventricular tachycardia (PSVT) termination.
- Previous research established etripamil's safety and efficacy in a medically supervised setting.
- The NODE-303 study assessed etripamil's use for multiple, at-home PSVT episodes without a preceding test dose.
Purpose of the Study:
- To evaluate the safety and efficacy of self-administered etripamil for multiple episodes of paroxysmal supraventricular tachycardia (PSVT) in a real-world, at-home setting.
- To assess the tolerability and effectiveness of etripamil without a prior medically supervised test dose.
- To analyze the safety profile and efficacy of both single and repeat doses of etripamil for PSVT termination.
Main Methods:
- Patients with suspected PSVT initiated ECG monitoring and self-administered etripamil (70 mg) if vagal maneuvers failed.
- A repeat 70 mg dose was permitted for persistent symptoms after 10 minutes.
- Safety was monitored via treatment-emergent adverse events (TEAEs) and ECGs; efficacy was measured by PSVT termination for each episode.
Main Results:
- Over 1000 PSVT episodes were treated with etripamil in 503 patients.
- The most common TEAEs were mild/moderate nasal discomfort (30.2%), congestion (13.9%), rhinorrhea (13.1%), and epistaxis (7.4%), with decreasing frequency across episodes.
- 70.5% of patients converted to sinus rhythm within 60 minutes of the first dose (median 18.3 min), with earlier conversion predicting subsequent success.
Conclusions:
- Self-administered etripamil nasal spray demonstrated good tolerability and effectiveness for PSVT termination in a real-world setting.
- The safety profile was consistent across single and repeat doses for multiple PSVT episodes.
- Etripamil offers a viable option for at-home, self-administered treatment of PSVT.
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