Sacubitril/Valsartan in everyday clinical practice: the experience of a heart failure clinic

Abstract

Aims: The PARADIGM-HF trial established the superiority of sacubitril/valsartan (Sac/Val) over Angiotensin Converting Enzyme inhibition in Heart Failure with reduced Ejection Fraction (HFrEF). In the present study, we aimed to characterise the challenges of sacubitril/valsartan use in everyday clinical conditions. Methods and results: We assessed the medical records of HFrEF patients attending a HF clinic at a tertiary Portuguese hospital during 2018 (n=240). The number of Sac/Val candidates, the number of patients who effectively received the drug, and the reasons for not prescribing Sac/Val were quantified. Additionally, we assessed the tolerability of maximal doses of Sac/Val. New York Heart Association functional class (NYHA class) and Left Ventricular Ejection Fraction (LVEF) before and after maximum tolerated Sac/Val dose were compared. Out of the 168 Sac/Val candidates, only 91 (54.2%) were prescribed the drug. The two main reasons for non-prescription were patient financial barriers (31.2%) and hypotension (27.3%). Only 34.4% reached Sac/Val maximal dose. Hypotension was the most frequent reason for under-titration. Duration of Sac/Val treatment showed a positive association with LVEF (6.91% absolute increase in LVEF/year). NYHA functional class significantly improved from baseline through the end of follow-up. Conclusions: Sacubitril/valsartan showed a positive change in NYHA functional class and in LVEF under real-life conditions. However, important financial and clinical barriers to the implementation of this therapy were identified. Keywords: heart failure; sacubitril/valsartan; neurohormonal modulation; real-life practice; prescription; financial barriers