Stambler BS, et al. Featured Clinical Research I. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
Stambler reports he received honoraria, consultant fees and contracted grants from Milestone Pharmaceuticals.
Etripamil nasal spray was associated with improving symptoms and reducing ED visits to terminate nodal-dependent paroxysmal supraventricular tachycardia outside the health care environment, according results of the NODE-301 study.
Bruce S. Stambler
“Etripamil 70 mg single-dose significantly improved PSVT-related symptoms; patient satisfaction and effectiveness of at-home nasal spray therapy for PSVT were higher for etripamil than placebo; and etripamil tended to reduce the need for emergency room medical interventions for PSVT,” Bruce S. Stambler, MD, FHRS, director of cardiac arrythmia research and education at Piedmont Heart Institute, Atlanta, said during a presentation at the American College of Cardiology Scientific Session.
As Healio previously reported, in the main results of NODE-301, etripamil (Millstone Pharmaceuticals), an L-type calcium channel blocker administered via nasal spray, missed the primary endpoint of conversion of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm at 5 hours compared with placebo, but bested placebo for conversion at 45 minutes.
For the present analysis, the researchers included the 156 patients from NODE-301 who had a confirmed vagal-maneuver refractory, symptomatic episode of sustained PSVT. In the etripamil group, the mean age was 57 years and 68% were women. In the placebo group, the mean age was 54 years and 67% were women.
Stambler said that compared with placebo, etripamil improved patient scores of the following PSVT related symptoms: rapid pulse (P = .002), palpitations (P < .001) shortness of breath (P = .008) dizziness (P = .012) and anxiety (P =.006). There was no difference between the groups in chest pain score.
According to Stambler, during the 5-hour observation period, 28 patients sought additional rescue medical interventions for PSVT; of those, 25 reported to the ED and three self-administered rescue oral medications for PSVT. Also, he said, 14% of the etripamil group compared with 26.5% of the placebo group sought additional medical therapy, usually IV adenosine in the ED (P = .059).
There was a trend for ED interventions to be less frequent in the etripamil group compared with the placebo group (12.1% vs. 24.5%; P = .051), according to Stambler.
A secondary analysis demonstrated a clinically meaningful early treatment effect showing that etripamil 70 mg was significantly more effective than placebo nasal spray in converting PSVT over the first 45 minutes (P = .002) after the nasal spray, Stambler said.
Mean time to ER intervention was 116 minutes in the etripamil group and 79 minutes in the placebo group (P < .05), he said.
Scores of the 9-Item Treatment Satisfaction Questionnaire for Medication favored the etripamil group for treatment effectiveness (54 vs. 35; P = .001) and global satisfaction (57 vs. 43; P = .007), but there was no difference in treatment convenience score, according to the researchers.
“These data support the continued development of etripamil nasal spray for acute treatment of PSVT outside the hospital,” Stambler said during the presentation.