|Former: Atención Farmacéutica|
|Journal edited by Rasgo Editorial since 1983|
Virginia Hernández Corredoira
EDITOR IN CHIEF
Manuela Velázquez Prieto
Jaime E. Poquet Jornet
Ramón Jódar Masanés
Lluís Campins Bernadas
Tomás Casasín Edo
Juan Carlos Juárez Giménez
Carles Quiñones Ribas
Volume 21 - Issue 5, September-October 2019
EVALUATION OF USE, EFFICACY AND SAFETY OF SACUBITRIL/VALSARTAN
CANALES SIGUERO DOLORES, CARO TELLER JOSE MANUEL, MARTÍNEZ DE LA TORRE FRANCISCO, FERRARI PIQUERO JOSÉ MIGUEL
Objective : Sacubitril/valsartan is the only drug marketed as a neprilysin inhibitor to treat heart failure. The results of the clinical trial PARADIGM-HF led to its approval in Spain in 2015. The AEMPS issued a therapeutic positioning report that defined the criteria for use for a specific population. The objective is to analyze its efficacy and safety in the health and hospital area class 5 (cluster classification of hospitals) and to evaluate the suitability of the prescription to the therapeutic positioning report.
Method : A retrospective observational study that included patients with heart failure treated with sacubitril/valsartan from its commercialization until March 2018.
It was recorded if the patients met the criteria of initiation according to therapeutic positioning report: functional class II-IV NYHA, left ventricular ejection fraction (LVEF)≤35%, previous treatment optimized with angiotensin-converting enzyme inhibitor or antagonist of the angiotensin II receptor, beta-blocker and aldosterone antagonist and plasma level of the amino-terminal fraction of the brain natriuretic peptide (NT-proBNP) elevated (≥600 pg/ml).
A follow-up was made through the electronic medical record. The variables collected were: age, sex, diagnosis, number of admissions, emergency visits and adverse events.
Results : We included 125 patients with 68.7±12.8 years. 100% of the prescriptions were made by Cardiology, adjusting in 38.4% to all the criteria of the therapeutic positioning report; 98.4% had heart failure II-IV NYHA, 81.6% had NT-proBNP levels>600 pg/ml, 69.6% had pre-treatment optimized and 65.6% of patients had LVEF≤35%. 26 patients (20.8%) presented hospital admissions and/or emergency visits due to decompensation of heart failure: there were 44 visits to the emergency and 23 hospital admissions (incidence of first hospitalization due to heart failure =13.6%). 88 patients (70.4%) presented adverse events that led to the suspension of treatment in 13 patients (10.2%). Most frequent adverse events: hypotension (40.8%), hyperkalemia (31.2%), and dizziness (28%) and impaired renal function (24.8%).
Conclusions : Less than 40% of the prescriptions were adapted to the therapeutic positioning report.
The incidence of first hospitalization due to heart failure was slightly higher than that obtained from the clinical trial PARADIGM-HF. The most observed adverse effect was hypotension.
LCZ 696, LBQ 657, SAFETY, HEART FAILURE, HYPOTENSION, EFFECTIVENESS