A report in the Journal of the American Heart Association points out that etripamil, a rapid- and short-acting investigational medication formulated to be delivered via nasal spray, restored a normal heart rhythm in less than 30 minutes in most users with intermittent rapid heartbeats. The recovery occurred without a visit to the emergency department to receive IV medication.
The industry-funded study led by researchers from Weill Cornell Medicine, New York-Presbyterian Hospital in New York also determined that participants were able to detect when they were experiencing tachycardia, defined as a heart rate greater than 100 beats/minute, and administer the medication appropriately and safely.
The article noted that the self-administered could help about 1 in 300 adults in the United States who are diagnosed with tachycardia every year. The product has not yet been approved by the FDA.
“This is a potential new and exciting option for patients to safely self-treat their rapid heartbeat without direct medical supervision to avoid emergency room visits and medical interventions,” said lead author James E. Ip, MD, an associate professor of clinical medicine at Weill Cornell Medicine at New York-Presbyterian Hospital in New York City.
The study team found that self-administration of investigational intranasal L-type calcium channel blocker etripamil during paroxysmal supraventricular tachycardia (PSVT) appeared safe and well-tolerated in the phase III NODE-301 (Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia) trial of adults with sustained atrioventricular nodal-dependent PSVT. The NODE-302 open-label extension further characterized etripamil safety and efficacy.
Among 169 patients enrolled, 105 self-administered etripamil one time or more for perceived PSVT (median [range], 232 [8-584] days’ follow-up). The participants were an average age of 58 years old, and 62% were women. Approximately 83% were white adults, with 8% African American, 3% Asian, 2% Native Hawaiian or Pacific Islander, and 5% other races.
According to the report, all participants had been diagnosed with PSVT and had experienced, on average, 9.7 episodes in the previous year. Most were taking long-acting medications to prevent rapid heartbeats.
With the primary endpoint defined as time-to-conversion of positively adjudicated PSVT to sinus rhythm after etripamil treatment, the probability of conversion within 30 minutes of etripamil was found to be 60.2% (median time to conversion, 15.5 minutes) among 188 PSVT episodes (92 patients) positively adjudicated as atrioventricular nodal dependent by independent electrocardiogram (ECG) analysis.
“Among 40 patients who self-treated 2 episodes, 75% had a significantly consistent response by 30 minutes; 9 did not convert on either episode, and 21 converted on both episodes (χ2 = 8.09; P = .0045),” the authors pointed out. “Forty five of 105 patients (42.9%) had ≥1 treatment-emergent adverse event, generally transient and mild-to-moderate, including nasal congestion (14.3%), nasal discomfort (14.3%), or rhinorrhea (12.4%). No serious cardiac safety events were observed within 24 hours of etripamil.”
The researchers concluded that investigational etripamil nasal spray was well tolerated for self-treating recurrent episodes of PSVT without medical supervision.
The standard treatment during a tachycardia episode is to slow the heart rate by performing vagal maneuvers. If the self-administered vagal maneuvers are not effective—something that occurs about 20% to 40% of the time—patients are advised to seek immediate emergency treatment and receive IV medication to return the heart rate to normal. In the U.S., approximately 50,000 emergency room visits yearly are for paroxysmal supraventricular tachycardia, Dr. Ip said.
In a previous study, people with the disorder treated themselves with either etripamil or a placebo nasal spray for a single episode of rapid heartbeat. The participants applied an ECG patch at the onset of symptoms, did a vagal maneuver, and self-administered the nasal spray if the rapid heartbeat continued—keeping the ECG patch on for at least 5 hours.
“In that study, the first time that etripamil was used without direct supervision, normal heart rhythms were restored within 30 minutes in 54% of patients, compared to 35% with placebo, and the medication was found to be safe and well tolerated,” the study press release stated. “The ECG patch is a wearable heart monitor that has a small device with an adhesive that sticks on the chest skin surface and is wirelessly connected to a cell phone to transmit the ECG data.”
All participants in that randomized trial were invited to participate in the current open-label study that allowed patients to self-treat with etripamil during multiple episodes of PSVT.
“There are no great options for patients to self-treat paroxysmal supraventricular tachycardia, and this condition can cause significant distress and anxiety,” Dr. Ip said. “Similar to an albuterol inhaler for asthma patients or an epinephrine pen for patients that have severe allergies or anaphylaxis, etripamil nasal spray may be a great option for people who have paroxysmal supraventricular tachycardia.”
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