Home > Cardiology > ACC 2021 > Electrophysiology > Etripamil nasal spray significantly improves PSVT-related symptoms

Etripamil nasal spray significantly improves PSVT-related symptoms

Presented by
Dr Bruce Stambler, Piedmont Heart Institute, USA
Conference
ACC 2021
Trial
Phase 3, NODE-301
Etripamil, a novel, L-type calcium channel blocker, significantly improved symptoms of paroxysmal supraventricular tachycardia (PSVT) and reduced the need for emergency interventions in the phase 3 trial NODE-301. Users reported higher levels of satisfaction and effectiveness than with a placebo [1].

Dr Bruce Stambler (Piedmont Heart Institute, GA, USA) reiterated the results of the phase 3 NODE-301 trial (NCT03464019), which were previously shared at the 2020 Heart Rhythm Society meeting. The multicentre NODE-301 study evaluated etripamil’s ability to terminate episodes of PSVT effectively and safely.

Participants with a history of ECG-documented PSVT were randomised in a 2:1 fashion to self-administer either intranasal etripamil (n=107) or placebo (n=49) during an episode of PSVT. The study population had a median age of 55 years and had a high burden and frequency of PSVT episodes over the past year, ranging from 7.4 episodes in the etripamil group to 11.3 in the placebo group. NODE-301 failed to meet its primary efficacy endpoint of superiority of a single, 70 mg dose of etripamil over placebo for a conversion of an episode of PVST over 5 hours (HR 1.09; 95% CI 0.73–1.62; P=0.12). A post-hoc secondary analysis was also performed, which considered the known pharmacology of etripamil with a rapid onset of action (within 5-10 minutes) and short duration of action (30-45 minutes). This analysis demonstrated a clinically meaningful early treatment effect with etripamil as compared with placebo; etripamil was significantly more effective than placebo at converting PSVT over the first 45 minutes after administration of the nasal spray (HR 1.67; 95% CI 1.03–2.7; P=0.02). Etripamil had an acceptable and favourable safety profile.

At ACC 2021, Dr Stambler discussed the secondary clinical endpoints of the NODE-301 trial, namely:


    • the relief of PSVT-specific symptoms (such as heart palpitations, rapid pulse, chest pain, anxiety, shortness of breath, dizziness, and fainting);
    • patient-reported satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9);
    • the need for any emergency interventions; and
    • the need for any additional rescue medication therapy.

Etripamil was more effective than placebo at relieving PSVT specific symptoms. TSQM-9 scores for global satisfaction with treatment and treatment effectiveness were both significantly higher in the etripamil group than in the placebo group. In the etripamil group, 14% of participants sought additional medical therapy compared with 26.5% in the placebo group; most commonly, this consisted of intravenous adenosine administered in the emergency room. During the 5-hour observation period after administration of etripamil, 28 participants sought additional rescue medication intervention; 25 of these presented to the emergency room, and 5 self-administered oral rescue medications for PSVT. The time to emergency room intervention was longer in the etripamil group than in the placebo group (116±14 vs 79±10 minutes; P<0.05).

The researchers concluded that further development of etripamil nasal spray for the treatment of PSVT is supported by these favourable data.


    1. Stambler BS. Etripamil Nasal Spray Relieves Symptoms and Reduces Emergency Room Interventions in Patients with Paroxysmal Supraventricular Tachycardia (PSVT). ACC 2021 Scientific Session, 15–17 May.

 

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