Results from the Phase 2 ReVeRA trial show that use of etripamil nasal spray is associated with rapid and statistically significant reductions in ventricular rate in patients with atrial fibrillation and rapid ventricular rates, demonstrating that, relative to placebo, every minute Reduce heartbeat by 30 beats. When used in episodes.
The findings, presented at the 2023 American Heart Association Scientific Sessions, provide further insight into the efficacy of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) as the PDUFA date approaches. Potential role of Pami Nasal Spray in the treatment of cardiac arrhythmias.1
“Breakthrough episodes of rapid ventricular rate in patients with AFib are common and often symptomatic, potentially burdening patients with daily life and disrupting the healthcare system. Today, there is an unmet need for portable, rapid-acting treatment solutions. Lead researcher, St. Louis A. John Camm, MD, British Heart Foundation Emeritus Professor of Clinical Cardiology, Institute of Molecular and Clinical Sciences, Clinical Academic Group in Cardiology: George University London.2 “The results presented and released today from the ReVeRA Phase 2 study are encouraging for patients and healthcare providers seeking a treatment solution that can significantly relieve symptoms and help reduce emergency room visits.“
ReVeRA is a randomized, double-blind, placebo-controlled study conducted at 23 sites in Canada and the Netherlands to evaluate the safety and efficacy of etripamil nasal spray relative to placebo in resolving rapid ventricular rates in patients with atrial fibrillation. effectiveness. For analysis purposes, a rapid ventricular rate was defined as 110 beats per minute or more.1
A total of 87 patients were screened in the trial. Of these, 69 underwent randomization and 56 received the assigned intervention, of which 27 received self-administered etripamil nasal spray and 29 received treatment. The primary outcome of interest in the trial was the effectiveness of etripamil nasal spray in reducing ventricular rate within 60 minutes of treatment relative to placebo treatment.1
The researchers noted that the study included multiple secondary endpoints. These included ventricular rate less than 100 beats per minute, 10% or more and 20% or more, symptom relief, adverse events and 360 additional minutes of measures.1
In analyzes adjusting for baseline ventricular rate, results showed a mean maximum difference over 60 minutes of -29.91 beats/minute in favor of etripapamil nasal spray (95% confidence interval, -40.31 to -19.52; ask <.0001), this effect lasts up to 150 minutes. Analyzes of secondary endpoints showed that compared with the placebo group, a greater proportion of patients in the etripamil nasal spray group experienced a reduction in heart rate of less than 100 beats per minute, a reduction of 10% or more, and a reduction of 20% or more. .1
The researchers highlighted that 66.7% of patients in the etripamil nasal spray group experienced a reduction in ventricular rate of 20% or more, but this did not occur in patients who received placebo. The researchers also highlighted significant improvements in symptom relief and treatment efficacy, as assessed using the Medication Treatment Satisfaction Questionnaire9, which noted that patients using etripapamil nasal spray experienced significant improvement compared with placebo. There are significant improvements in both areas. Safety analysis showed that serious adverse events were rare, with one patient in the etripamil nasal spray group experiencing a brief episode of severe bradycardia and syncope.1
As part of our AHA 2023 coverage, HCPLive Cardiology sat down with ReVeRA investigator Dr. James Ip, associate professor of clinical medicine and director of cardiac pacing and implantable devices at Weill Cornell Medical College, to get more perspective on the trial and How it can help As the 2024 PDUFA date for etripapamil nasal spray for the treatment of PSVT approaches, further reporting on the drug’s potential is available to electrophysiologists and other caregivers.
Ip related disclosures include Milestone Pharmaceuticals.
refer to:
- Camm AJ, Piccini JP, Alings M, et al. A multicenter, phase 2, randomized, controlled study investigating the efficacy and safety of etripamil nasal spray for acute reduction of ventricular rapid rate in patients with symptomatic atrial fibrillation (ReVeRA-201). Circulation: Arrhythmias and Electrophysiology. Published online on November 11, 2023. doi:10.1161/CIRCEP.123.012567
- Milestone Pharmaceuticals presented positive results from the Revera Phase 2 study of etripamil in afib-RVR at the 2023 American Heart Association Scientific Sessions. Milestone Pharmaceuticals, Inc. November 11, 2023. Accessed 11 November 2023. https://investors.milestonepharma.com /PRESS RELEASE / PRESS RELEASE DETAILS / Milestone Pharmaceuticals Presents Positive Results for Revira Phase I