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Eligibility for vericiguat in a real‐world, contemporary heart failure population.

Authors :
Vergaro, Giuseppe
Aimo, Alberto
Gentile, Francesco
Mandoli, Giulia Elena
Focardi, Marta
Castiglione, Vincenzo
Giannoni, Alberto
Panichella, Giorgia
Fornaro, Alessandra
Carluccio, Erberto
Liga, Riccardo
Salatin, Mattia
Passino, Claudio
Piepoli, Massimo F.
Cameli, Matteo
Cappelli, Francesco
Di Mario, Carlo
Emdin, Michele
Source :
ESC Heart Failure; Dec2024, Vol. 11 Issue 6, p3523-3529, 7p
Publication Year :
2024

Abstract

Aims: Vericiguat is a soluble guanylate cyclase stimulator and improves survival in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and an increased risk of decompensation. As real‐world data on how many patients could be eligible for vericiguat therapy derive from outdated registries, we aimed to assess eligibility in a prospective cohort of patients with HF. Methods and results: Data from consecutive HF patients undergoing an elective ambulatory visit at five university hospitals from 3 July to 28 July 2023 were collected. Independent investigators assessed which patients (i) met the eligibility criteria of the VICTORIA trial, (ii) complied with HF guideline recommendations, (iii) met regulatory agency criteria, or (iv) met criteria for refundability according to the Italian regulatory agency. Patients (n = 346, 72% men, median age 69 years) had HFrEF in 57% of cases, left ventricular ejection fraction < 45% in 68%, and New York Heart Association class II–IV symptoms in 76%. Patients meeting the eligibility criteria of the VICTORIA trial or European and American HF Guideline recommendations were 9% and 13%, respectively. Patients meeting Food and Drug Administration (FDA) or European Medicines Agency (EMA) label criteria were 19% and 17%, respectively. Drug costs would be covered by the Italian National Health System in 10% of patients [if a sodium‐glucose cotransporter‐2 inhibitor (SGLT2i) is not mandatory] or in 8% (if an SGLT2i is requested). Conclusions: In a real‐world study, 9% of patients met the eligibility criteria of the VICTORIA trial, but up to 13% complied with guideline recommendations and up to 19% met FDA or EMA criteria. In Italy, drug costs would be covered by up to 10% of patients. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
20555822
Volume :
11
Issue :
6
Database :
Complementary Index
Journal :
ESC Heart Failure
Publication Type :
Academic Journal
Accession number :
181548570
Full Text :
https://doi.org/10.1002/ehf2.14767