Novartis Reports Results of Entresto (sacubitril/valsartan) in Three P-III PARAGON-HF and P-IV PROVE-HF with EVALUATE-HF Studies for Patients with HFpEF and HFrEF
Shots:
- The P-III PARAGON-HF study involves assessing of Entresto vs valsartan in 4-822 HF patients with preserved ejection fraction- resulted in 13% reduction in HF hospitalization and CV death- 15% reduction in total HF hospitalization but narrowly missed the statistical significance- patients with left ventricular ejection fraction ≤57% median showed greater effect
- The P-IV PROVE-HF study involves assessing of Entresto in HF patients with reduced ejection fraction (HFrEF) for 52wks. resulted in improvement in cardiac biomarker- NT-proBNP leading to a change in heart structure and its function. The P-IV EVALUATE-HF study involves assessing of Entresto vs enalapril in 464 patients with HFrEF- results showed improved structure and function of left ventricle and safety consistent with P-III PARADIGM-HF study
- Entresto act by reducing the strain on the failing heart by enhancing the natriuretic peptide system and inhibiting the harmful effect of RAAS and is indicated in patients with chronic heart failure with reduced ejection fraction in EU
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