Evaluation of use, efficacy and safety of sacubitril/valsartan

• Autores: Dolores Canales Siguero, José Manuel Caro Teller, Francisco Martínez de la Torre, José Miguel Ferrari Piquero
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 21, Nº. 3, 2019, págs. 144-148
• Idioma: inglés
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• Resumen

  • 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