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Sacubitril/valsartan for heart failure with reduced ejection fraction: A first real-life observational study in
Małgorzata Lelonek1, Sylwia Wiśniowska-Śmiałek2, Paweł Rubiś2
1Department of Noninvasive Cardiology, Medical University of Lodz, Poland.
Insights
Sacubitril/valsartan significantly improved heart failure with reduced ejection fraction (HFrEF) symptoms and markers in Polish patients over one year. Early initiation and dose titration are recommended for better outcomes in HFrEF management.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Heart failure with reduced ejection fraction (HFrEF) remains a significant clinical challenge with unfavorable prognosis despite treatment advancements.
- Optimizing pharmacotherapy for HFrEF is crucial for improving patient outcomes.
Purpose of the Study:
- To assess the one-year effectiveness, tolerance, and safety of sacubitril/valsartan in Polish patients with stable chronic HFrEF.
- To identify predictors of adverse outcomes in HFrEF patients treated with sacubitril/valsartan.
Main Methods:
- An observational, multicenter study involving 89 ambulatory HFrEF patients (NYHA class II-IV).
- Clinical, laboratory, and echocardiographic parameters were assessed at baseline and after one year.
- The composite endpoint included death or urgent heart failure hospitalization.
Main Results:
- Significant improvements were observed in heart failure symptoms, NT-proBNP levels, ejection fraction (EF), and six-minute walk test distance (p < 0.001).
- Higher doses of sacubitril/valsartan correlated with greater clinical benefits.
- Therapy discontinuation due to side effects occurred in 11% of patients; predictors for the composite endpoint included prior HF hospitalization, TAPSE, and ACEI-naive status.
Conclusions:
- Sacubitril/valsartan treatment demonstrated safety and efficacy in chronic HFrEF patients, leading to substantial clinical and objective improvements.
- Early initiation and dose escalation of sacubitril/valsartan are advised for patients with more advanced heart failure to improve survival.
Background:
Despite the progress in the treatment of heart failure with reduced ejection fraction (HFrEF), the prognosis remains unfavorable.
Objectives:
To evaluate the effectiveness, tolerance and safety after one-year follow-up of Polish patients with stable chronic HFrEF treated with sacubitril/valsartan.
Material And Methods:
This was an observational multicenter study conducted in 3 centers (Kraków, Łódź and Warszawa) specializing in heart failure (HF). We enrolled 89 HFrEF patients (aged 59.3 ±13.5 years, 82% males) in NYHA class II-IV (ambulatory). Clinical, laboratory and echocardiographic parameters were evaluated at baseline and after a one-year follow-up. The composite endpoint was defined as death or urgent HF hospitalization.
Results:
After 1 year, 80% of patients used 50% or more of the target dose of sacubitril/valsartan. After a year of treatment, there were significant improvements of HF symptoms, N-terminal prohormone B-type natriuretic peptide (NT proBNP), ejection fraction (EF), and distance in six-minute walk test (6MWP) (all p < 0.001). Patients treated with the highest dose of sacubitril/valsartan exhibited the greatest benefits. The safety profile was favorable and consistent with that previously reported; however, therapy discontinuation due to side effects occurred in 11% of patients. The independent predictors for composite endpoint (n = 24, 26.9%) were history of HF hospitalization, tricuspid annular plane systolic excursion (TAPSE) and angiotensin-converting-enzyme inhibitor (ACEI)-naive patients.
Conclusions:
Treatment of chronic HFrEF patients with sacubitril/valsartan is safe and is associated with significant clinical and objective improvement. The non-survivors had more advanced HF, so the initiation and uptitration of sacubitril/valsartan should be done early.
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