M. Rizzo1, I. Colomer-Asenjo1, M. Sutil-Vega1, G. Cabello-Molina1, S. Marín-López1, F. Taibi-Hajjami1, C. Roca-Guerrero1, D. García-Vega1, M. Panelo-Rubio1, M. Bonastre-Thio1, A. Martínez-Rubio1 (1Sabadell (Barcelona) ES)
Aims: To describe the clinical characteristics, safety and tolerability profile, and discontinuation causes of sacubitril/valsartan (S/V) treatment in patients attending to an outpatient heart failure clinic.
Design & methods: We collected data from 119 consecutive patients between May and November 2018. Variables were collected baseline and post-S/V titration period.
Results: 64 patients (53,8%) were treated with S/V. At baseline, mean age was 63±10 years,76,6% men. Mean LVEF 28±6%. 39% ischemic etiology. 67% NYHA II. Median NT-proBNP 1176pg/ml (IQR 364-3945). Mean glomerular filtration rate (GFR) 71,7±20,6mL/min and potassium 4,4±0,4mEq/L. 84% of patients were treated with ACE inhibitors or ARBs, 95% beta-blockers and 86% mineralocorticoid receptor antagonists. Median titration time was 6,5 weeks (IQR 3-13,2). Target dose was achieved in 23 patients (40%). 24 (37,5%) needed dose reduction and 10 (15.6%) discontinued therapy. Causes for therapy discontinuation were hypotension defined as SBP <90 mmHg (<n=4, 6,2%), Potassium >5,5meq/L (n=2, 3,1%) and diarrhea (n=1, 1,6%). Patients who presented at least one adverse event were older, with lower SBP and GFR (all p<0.05). In a multivariate analysis a lower SBP (OR 0,94 95%CI 0.90-0,99) was the only variable independently associated with adverse events.
Conclusions: In our cohort, S/V has an acceptable tolerability profile. The proportion of patients who achieved target dose was lower than the reported in clinical trials, despite a longer titration time. Hypotension represents the main cause of reduction or discontinuation of S/V.