Objectives: Paroxysmal supraventricular tachycardia (PSVT) causes economic burden due to a frequent need for medical interventions and emergency department (ED) visits with substantial costs. The NODE-301 study evaluated the efficacy and safety of the novel, fast-acting, investigational intranasal calcium channel blocker etripamil for conversion of PSVT in an at-home setting. This analysis assessed the impact of etripamil on the need for additional medical intervention.
Methods: NODE-301 was an event-driven, randomized, double-blind, placebo-controlled study. During a PSVT episode, patients self-administered study drug intranasally outside a medical setting. In Part 1, 419 patients were randomized to etripamil 70 mg or placebo, and in Part 2 (RAPID), 692 patients were randomized to etripamil 70 mg or placebo with a repeat dose if symptoms persisted. In this prespecified, pooled analysis, the proportion of patients receiving medical intervention for PSVT after administering etripamil or placebo was examined.
Results: Demographics included mean age 54.8 years, 69.6% female, and mean 8.2 PSVT episodes in the prior year. Of patients in optional second-dose arms in the efficacy population (n=155), 57 (79.2%) using placebo and 55 (66.3%) using etripamil took a second dose. Across randomized patients, 340 treated an episode with placebo (n=134) or etripamil (n=206). Thirty-four (25.4%) randomized to placebo and 30 (14.6%) randomized to etripamil received additional intervention (oral or intravenous medications) (P=0.013). Thirty (22.4%) on placebo and 28 (13.6%) on etripamil required an ED visit for an episode of PSVT (P=0.035). The most common adverse events were related to the nasal administration site. No serious adverse events were related to study drug. Safety and tolerability data were consistent with those observed in prior trials.
Conclusions: Etripamil, an investigational drug, reduced the need for medical intervention, including ED visits, for PSVT in NODE-301. These preliminary findings suggest that self-administered etripamil may lower the healthcare burden and costs in patients with PSVT. ❑
© 2023 International Society for Pharmacoeconomics and Outcomes Research. Reused with permission. This abstract was accepted and previously presented at the ISPOR 2023 conference; Boston, MA, USA. All rights reserved.
