Etripamil reduces ventricular rate in patients with AF
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Key takeaways:
- Etripamil reduced ventricular rate in patients with atrial fibrillation and rapid ventricular rate compared with placebo in a phase 2 trial.
- The nasal spray will be tested for this purpose in a phase 3 trial.
PHILADELPHIA — Etripamil, a nasal spray, reduced ventricular rate in patients with atrial fibrillation and rapid ventricular rate, researchers reported at the American Heart Association Scientific Sessions.
“A rapid ventricular rate produces symptoms similar to those experienced after running quickly or after receiving a shocking piece of news. However, since this occurs very suddenly ... it is very frightening to the patient and this anxiety worsens the situation. The feeling of your heart running away with itself is very alarming, especially to those who have not become used to the sensation,” A. John Camm, MD, British Heart Foundation Emeritus Professor of Clinical Cardiology, The Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, told Healio. “There is also a hemodynamic disadvantage (ie, decreased cardiac output and efficiency) that may limit the activity of patient and might cause the atrial fibrillation to persist for a longer period (but this has not yet been demonstrated in this program).”
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For the ReVeRA-201 trial, Camm and colleagues randomly assigned 69 patients (median age, 65 years; 39% women) with AF who presented urgently with rapid ventricular rate, defined as 110 bpm or more, to etripamil 70 mg (Milestone Pharmaceuticals) or placebo.
“Etripamil slows atrioventricular conduction (lengthens the PR interval on the ECG) and prolongs the refractoriness (recovery time) of the atrioventricular node,” Camm told Healio. “Some patients enrolled in previous paroxysmal supraventricular tachycardia (PSVT) studies had atrial fibrillation rather than PSVT and their ventricular rates dropped markedly after administering etripamil nasal spray (70 mg). It was the intention of ReVeRA to document and more fully evaluate this finding in a randomized, double-blind, phase 2 study. In the study, etripamil reduced the heart rate by about 30 bpm (compared to placebo) and this effect was not transient in that it lasted up to 2.5 hours. The therapy improved patient-reported outcomes including relief of symptoms.”
The results were simultaneously published in Circulation: Arrhythmia and Electrophysiology.
After adjustment for baseline ventricular rate, the difference of mean maximum reductions in ventricular rate over 1 hour favored the etripamil group (–29.91 bpm; 95% CI, –40.31 to –19.52; P < .0001), according to the researchers.
More patients in the etripamil group than in the placebo group had ventricular rate reductions of more than 100 bpm, with a longer median duration of a reduction of more than 100 bpm, or a reduction of at least 10%, or a reduction of at least 20%, Camm and colleagues found.
In the etripamil group, 66.7% of patients had a ventricular rate reduction of at least 20%, compared with none in the placebo group, according to the researchers.
The etripamil group had more improvement in satisfaction on symptom relief and treatment effectiveness than the placebo group per the Treatment Satisfaction Questionnaire for Medication-9, Camm and colleagues found.
“The ability of patients to rapidly reduce their heart rate when [AF with rapid ventricular rate] suddenly occurs allows them to quickly control their symptoms,” Camm told Healio. “This should give patients time to tolerate their atrial fibrillation until it spontaneously terminates or to implement other therapies to deal with their arrhythmias, or to seek medical attention. These options will be further explored in future studies.”
Serious adverse events were rare; one patient in the etripamil group had transient severe bradycardia and syncope, attributed to hypervagotonia, according to the researchers.
“The results from the ReVeRA study are promising and demonstrate the potential of etripamil nasal spray to rapidly reduce heart rate and provide symptomatic benefit to patients suffering from [AF with rapid ventricular rate],” Camm told Healio. “A phase 3 registrational program will be initiated in mid-2024 in partnership with Milestone Pharmaceuticals to evaluate self-administered etripamil as a potential treatment for patients with [AF with rapid ventricular rate].”
Reference:
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Camm AJ, et al. FS.01. Innovations in EP care. Presented at: American Heart Association Scientific Sessions; Nov. 11-13, 2023; Philadelphia.
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