Sacubitril/Valsartan in Heart Failure with Reduced Ejection Fraction: Real-World Experience from Italy (the REAL.IT Study)

• Published in: Journal of clinical medicine Vol. 12; no. 2; p. 699
• Main Authors: Di Lenarda, Andrea, Di Gesaro, Gabriele, Sarullo, Filippo Maria, Miani, Daniela, Driussi, Mauro, Correale, Michele, Bilato, Claudio, Passantino, Andrea, Carluccio, Erberto, Villani, Alessandra, Degli Esposti, Luca, d'Agostino, Chiara, Peruzzi, Elena, Poli, Simone, Iacoviello, Massimo
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 16.01.2023; MDPI
• Subjects: Age; Blood pressure; Cardiac function; Clinical medicine; Cohort analysis; Demographics; Diabetes; Drug therapy; Ejection fraction; Electronic health records; Heart failure; Heart rate; Hypertension; Laboratories; Medical records; Mortality; Observational studies; Outpatient care facilities; Patients; Variables; Italy; NYHA functional class; real-world practice; heart failure with reduced ejection fraction; angiotensin receptor-neprilysin inhibitor; sacubitril/valsartan
• ISSN: 2077-0383; 2077-0383
• DOI: 10.3390/jcm12020699

Sacubitril/valsartan reduces heart failure (HF)-related hospitalizations and cardiovascular mortality in PARADIGM-HF and has become a foundational treatment for HF with reduced ejection fraction (HFrEF). However, data of its routine real-world use are limited, and evidence from Italian settings is lacking. The REAL.IT study aimed to characterize the demographics, pharmacotherapy, clinical characteristics and outcomes of sacubitril/valsartan-treated Italian patients with HFrEF. Electronic medical records of patients initiating sacubitril/valsartan from October 2016 to June 2019 at nine specialized hospital outpatient HF centers across Italy were reviewed. Overall, 924 adults (mean age 64.5 years, 84.6% male) were included. At baseline, 38.7% had an ischemic HF etiology, 45.9% hypertension, 23.2% atrial fibrillation, 25.4% diabetes mellitus, 26.1% an implantable cardioverter-defibrillator and 31.9% coronary artery bypass grafting. There were no clear patterns of patient selection over time. During follow-up, NYHA class improved in 37.5% of patients after a mean of 5.3 ± 3.8 months; 36.1% and 16.7% of patients were in NYHA class III during characterization and after one year of follow-up, respectively. Left ventricular ejection fraction (LVEF) improved ≥5% in 56.3% of patients at one year; 39.7% had ≥30% reduction of N-terminal pro-B-type natriuretic peptide; 2.2% had hyperkalemia during characterization and 2.6% during follow-up; and 3.8% had hypotension during characterization and 12% during follow-up. A total of 50 (5.8%) of patients had device implantation (ICD/CRT) during follow-up. HF-related hospitalization was recorded in 19.6% of patients during follow-up; 3.8% of patients died, approximately 1.3% from cardiovascular causes. Our real-world data confirm the favorable effectiveness and tolerability of sacubitril/valsartan observed in pivotal randomized controlled trials.