CL_I_L: Clinical Medicine I. Lectures
Introduction: PARADIGM-HF trial demonstrated superiority of sacubitril/valsartan over enalapril in patients with heart failure with reduced ejection fraction (HFrEF). However, patients in clinical practice may differ in their characteristics and overall risk compared with patients in clinical trials, and additional outcomes can be observed in real world.
Aims: Our aim was to evaluate the effectiveness, tolerance and safety after six-months follow-up of Hungarian patients with stable chronic HFrEF treated with sacubitril/valsartan.
Methods: We enrolled 250 HFrEF patients (aged 66 years, 89% males) in NYHA class II–IV. Clinical, laboratory and echocardiographic parameters were evaluated at baseline and at 3 and 6 months.
Results: At baseline the median ejection fraction (EF) was 28%, the median NT-proBNP level was 2673 pg/ml, the median eGFR level was 61.1 and the average potassium level was 4.6 mmol/l. The EF showed significant improvement at 6 month follow-up. The NT-proBNP level showed also showed significant improvement at 6 month FU. The eGFR and potassium levels didn’t change significantly. The average follow-up was 247 days. 25 patients (10%) died, and 7 patients underwent heart transplantation or ventricle assist device implantation. 26 patient reached the maximum dosage. The treatment has to be stopped in 8 cases (3%).
Conclusion: Efficacy of sacubitril/valsartan in terms of both mortality and hospitalization, symptoms and quality of life is significantly better than ACE inhibitors. It is safe to use and has a better side effect profile than ACE inhibitors. In proper patient selection, NT-proBNP levels plays a key role and should be measured as part of heart failure care.
Semmelweis University, Doctoral School of Theoretical and Translational Medicine