Heart Rhythm Society

Heart Rhythm Society

Source:

Ip JE, et al. Late Breaking Clinical Trials: Clinical Innovations. Presented at: Heart Rhythm 2022; April 29-May 1, 2022; San Francisco (hybrid meeting).

Disclosures: The study was sponsored by Milestone Pharmaceuticals. Ip reports receiving compensation as a study investigator and steering committee member from Milestone Pharmaceuticals and has received honoraria, advisory, speaking or consultant fees from Abbott, Biotronik, Boston Scientific and Medtronic.
May 01, 2022
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Fast-acting nasal spray safe for self-treatment of paroxysmal supraventricular tachycardia

Source:

Ip JE, et al. Late Breaking Clinical Trials: Clinical Innovations. Presented at: Heart Rhythm 2022; April 29-May 1, 2022; San Francisco (hybrid meeting).

Disclosures: The study was sponsored by Milestone Pharmaceuticals. Ip reports receiving compensation as a study investigator and steering committee member from Milestone Pharmaceuticals and has received honoraria, advisory, speaking or consultant fees from Abbott, Biotronik, Boston Scientific and Medtronic.
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A fast-acting nasal spray was safe and effective for patients self-treating for repeated episodes of paroxysmal supraventricular tachycardia during long-term follow-up, according to findings from the open-label NODE-302 study.

There is an unmet need for a safe, rapid, self-treatment of paroxysmal supraventricular tachycardia (PSVT) in a medically unsupervised setting, James E. Ip, MD, FHRS, associate professor of clinical medicine and clinical cardiac electrophysiologist at Weill Cornell Medicine and New York-Presbyterian Hospital, said during a presentation at Heart Rhythm 2022.

Source: Adobe Stock.
Source: Adobe Stock

“There are no good treatments for SVT as an outpatient,” Ip said during a press conference. “For patients who have repetitive episodes of SVT, they may try a vagal maneuver, but if that does not stop it, they may go to the ED and get an IV medication or oral medication, but none of this is approved for use and may have delayed onset.”

Etripamil (Milestone Pharmaceuticals) is a novel, fast-acting non-dihydropyridine, L-type calcium channel blocker in development as a self-administered nasal spray to treat PSVT. The pharmacodynamic effects occur 30 to 40 minutes after administration, Ip said.

Study design

As Healio previously reported, the NODE-301 study demonstrated that a 70-mg dose of etripamil significantly improved PSVT-related symptoms; patient satisfaction and effectiveness of at-home nasal spray therapy for PSVT were higher for etripamil vs. placebo; and etripamil tended to reduce the need for ED medical interventions for PSVT.

“Because the primary endpoint was time to PSVT conversion to sinus rhythm at the end of 5 hours, [the NODE-301 trial] did not meet its primary endpoint,” Ip said. “This is because many patients in the placebo-controlled arm received medical intervention and were censored earlier than those treated in the etripamil arm. However, there was a time to therapeutic conversion of 53% in the etripamil-treated arm compared with 35% in the placebo arm.”

Patients who participated in the NODE-301 trial and experienced an event were invited to participate in the open-label NODE-302 trial (n = 169), which had the same key inclusion criteria — adults with ECG-documented PVST, with episodes lasting more than 20 minutes.

“After a perceived episode of PSVT, patients were instructed to apply a cardiac monitoring system or an ECG patch,” Ip said. “They then performed a trained vagal maneuver. If the episode persisted, the patient administered etripamil 70 mg, one spray in each nostril.”

An independent adjudicating committee evaluated ECG recordings to determine PSVT episodes and conversion; patients continued in the study for up to 11 treated episodes. Median time in the study was 223 days; mean age was 58 years and 62% of patients were women.

Researchers observed 188 positively adjudicated PVST events in 92 patients. Among those patients, 56.5% used the drug a single time and 43.5% used etripamil for two or more episodes.

Kaplan-Meier estimates of time to conversion to sinus rhythm were 60.2% at the end of 30 minutes and 75% at the end of 60 minutes. Median time to conversion was 15.5 minutes.

Consistent response

“The was a consistent response to etripamil between the first and second PVST episodes and 75% had a consistent response,” Ip said. “It is also important to note that out of 14 patients who did not convert during the first episode, five of them still converted on the second episode.”

Ip said there were no new safety signals observed in the open-label study; most adverse events were mild, local and transient and were primarily related to nasal irritation.

“These results demonstrate a potential management strategy for patients to self-treat recurrent episodes using etripamil in a medically unsupervised setting,” Ip said.

The ongoing RAPID study, evaluating the safety and efficacy of a second dose of etripamil after 10 minutes if PVST continues, is expected to be completed later this year, Ip said.