J Am Heart Assoc

Self-administered nasal spray safe and effective for PSVT

October 10, 2023

The investigational intranasal L-type calcium channel blocker etripamil was well-tolerated for self-treating recurrent episodes of paroxysmal supraventricular tachycardia (PSVT) without medical supervision.

• Self‐administration of etripamil during PSVT appeared safe and well‐tolerated in the phase 3 NODE‐301 trial of adults with sustained AV nodal‐dependent PSVT.
• NODE‐302 was an open‐label extension intended to further characterize etripamil safety and efficacy. Eligible participants were monitored via a self‐applied cardiac monitoring system for five hours after etripamil self‐administration. Primary end-point was time‐to‐conversion of positively adjudicated PSVT to sinus rhythm after etripamil treatment. Adverse events were based on self‐reported symptoms and clinical evaluations.
• Among 169 patients enrolled, 105 self‐administered etripamil ≥1 time for perceived PSVT during a median follow-up of 232 days. Among 188 PSVT episodes (in 92 patients) positively adjudicated as AV nodal dependent by independent ECG analysis, the probability of conversion within 30 minutes of etripamil was 60.2%, with a median time to conversion of 15.5 minutes. Among 40 participants with 2 self‐treated episodes, 75% had a significantly consistent response by 30 minutes; 9 didn’t convert on either episode, and 21 converted on both episodes. Forty‐five of 105 patients (42.9%) reported ≥1 treatment‐emergent adverse event. These were generally transient and mild‐to‐moderate, including nasal congestion, nasal discomfort, or rhinorrhea. No serious cardiac safety events were reported within 24 hours of etripamil.

Source:

Ip JE, et al. (2023, September 27). J Am Heart Assoc. Etripamil Nasal Spray for Conversion of Repeated Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia During Long-Term Follow-Up: Results From the NODE-302 Study. https://pubmed.ncbi.nlm.nih.gov/37753718/