Plain language summary of the safety and effectiveness of etripamil for atrioventricular-nodal-dependent supraventricular tachycardia: the RAPID study
Abstract
What is this summary about?
This is a plain language summary of a clinical research study called RAPID. The study looked at the potential for how safe and effective etripamil was at stopping an episode of rapid heartbeats in people with atrioventricularnodal-dependent supraventricular tachycardia (AV-node-dependent SVT). An episode is used to describe the period of time when a person experiences an abnormally very fast heartbeat. This was done by comparing an investigational drug called etripamil with a placebo, each administered via a rapidly acting nasal spray.
AV-node-dependent SVT affects the rhythm of the heart, causing it to suddenly beat rapidly. The condition often requires medical treatment to help return the heart to its normal, healthy heartbeat pattern and speed, called ‘sinus rhythm’. Researchers are looking at ways of improving the management of supraventricular tachycardias (SVT) by reducing the need for patients to attend an urgent care clinic, emergency ward or hospital for treatment.
In the RAPID study, participants used a nasal spray containing either 70 mg etripamil or a placebo solution when they experienced an episode of SVT. The researchers wanted to know how long it took for each participant's rapid heartbeat to return to sinus rhythm after administering the etripamil or placebo nasal spray. Participants in the study were considered successfully treated if their heartbeats returned to sinus rhythm for at least 30 seconds within 30 minutes of using the nasal spray. Although 30 seconds may seem brief, it's medically important because it shows that a person's heartbeat has been temporarily stabilized and returned to normal functioning.
What were the results?
Out of 99 people who used etripamil during an SVT episode, 63 participants (64%) experienced a return to sinus rhythm for at least 30 seconds within 30 minutes after using the nasal spray. In contrast, 26 out of 85 participants (31%) who used the placebo nasal spray experienced a return to sinus rhythm for at least 30 seconds within 30 minutes after use. Furthermore, the average time taken for the return to sinus rhythm was 17 minutes for the etripamil group which was 3-times faster than the placebo group at 53 minutes. Also, in the study no serious side effects occurred that were related to etripamil.
What do the results of the study mean?
The RAPID study supports the potential that etripamil may be safe and well tolerated by participants as a treatment for episodes of rapid heartbeat in people with AV-node-dependent SVT. The results also showed a significant improvement in symptoms following treatment with etripamil.
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Acknowledgments
Milestone Pharmaceuticals and authors thank all of the participants, their families, and health care professionals who made this study possible.
Authors of the RAPID publication: Bruce S Stambler1, A John Camm2, Marco Alings3, Paul Dorian4, Hein Heidbuchel5, Jaco Houtgraaf6, Peter R Kowey7, Jose L Merino8, Blandine Mondésert9, Jonathan P Piccini10, Sean D Pokorney11, Philip T Sager12, Atul Verma13, J Marcus Wharton14, David B Bharucha15, Francis Plat16, Silvia Shardonofsky17, Michael Chen18, James E Ip19
1Cardiac Arrhythmia Research and Education, Piedmont Heart Institute, Atlanta, GA, USA; 2Clinical Cardiology, St George's University of London, London, UK; 3Department of Surgery, Amphia Ziekenhuis, Breda, Netherlands; 4Division of Cardiology, Department of Medicine, University of Toronto, Toronto, ON, Canada; 5Cardiology, University Hospital Antwerp, Antwerp, Belgium; Cardiovascular Research, Antwerp University, Antwerp, Belgium; 6Cardiology, Diakonessenhuis Hospital, Utrecht, Netherlands; 7Medicine and Clinical Pharmacology, Jefferson Medical College, Philadelphia, PA, USA; Lankenau Heart Institute and Medical Research Center, Wynnewood, PA, USA; 8Arrhythmia-Electrophysiology Research Unit, La Paz University Hospital, IdiPAZ, Universidad Autonoma, Madrid, Spain; 9Electrophysiology Service, Montreal Heart Institute, University de Montréal, Montréal, QC, Canada; 10,11Department of Medicine, Duke University School of Medicine, Durham,NC, USA; 12Stanford Cardiovascular Service, Stanford University School of Medicine, Palo Alto, CA, USA; 13Institute of Medical Science, University of Toronto, Newmarket, ON, Canada; 14Frank P Tourville Sr Arrhythmia Center, Medical University of South Carolina, Charleston, SC, USA; 15,16Milestone Pharmaceuticals, Charlotte, NC, USA; 17Milestone Pharmaceuticals, Montréal, QC, Canada; 18TCM Groups, Berkeley Heights, NJ, USA; 19Clinical Medicine, Weill Cornell Medical Center, New York, NY, USA
Financial & competing interests disclosure
All disclosures can be found in the original article.
Writing disclosure
Medical writing assistance was provided by Nicola Turner, BA and Danielle Birchall, MRes MICR of Simplifying Science® and was supported financially by Milestone Pharmaceuticals. Simplifying Science® is a registered trademark in Great Britain and Northern Ireland. Trademark No. UK00003709258. Owned by and registered to Lay Writing Services Ltd.
Open access
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