Abstract
Objective: Sacubitril/Valsartan (SV) has been shown to reduce cardiovascular mortality in ambulatory patients with chronic heart failure (CHF) and reduced left ventricular ejection fraction (HFrEF). However there are few real-word evidences about its efficacy in elderly hypertensives with HFrEF and comorbidities. Design and method: In this prospective open-label study, 54 subjects (mean age 78.6 ± 8.2 years, 75.0% men), with HFrEF (29.8 ± 4.3%), in New York Heart Association (NYHA) class II-III were assigned to receive SV twice daily at different dosage of 24/26, 49/51, 97/103 mg. These patients were gender and age-matched with a control group of patients with HFrEF receiving optimal standard therapy for CHF. The office blood pressure (BP), the NT-pro-BNP, eGFR, blood glucose and glycated haemoglobin (HbA1c), uric acid (UA), left ventricular ejection fraction (LVEF) and NYHA class were evaluated at a mean follow-up of 14-months. Mortality and re-hospitalisation for HF were collected. Categorical variables were compared with the Pearson's test and difference of continuous variables, were evaluated by the analysis of variance for repeated measures. Results: NYHA class significantly improved in the SV than control group (24.9 vs. 6.4% moved from III-- > II and 55.4 vs. 25.2% from II-- > I classes, p < 0.05). A significant improvement of LVEF and eGFR levels was found in the ARNIs than controls (42.4 vs. 34.2%, 73.8 vs. 61.2 ml/min for all p < 0.001, respectively). The NT-pro-BNP, systolic BP, diastolic BP, blood glucose, HbA1c and UA values were lower in SV than controls (3107 vs 4552 pg/ml, 112.2 vs. 120.4 and 68.8 vs 75.6 mmHg, 108.4 vs 122.6 mg/dl, 5.4 vs. 5.9% and 5.9 vs 6.4 mg/dl, p < 0.05). Mortality and re-hospitalisation for CHF was lower in the SV than controls (20.1 vs. 33.6 and vs. 27.7 vs. 46.3%, p < 0.05). Conclusions: In elderly hypertensives with HFrEF and comorbidities SV treatment seems effective and safe. The improvement of LVEF, BP, eGFR, serum glucose, UA and HbA1c could be the mechanisms by which SV plays a beneficial role on clinical outcomes
Published Version
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