pharmafileApril 17, 2018
Tag: Novartis , chronic heart failure
Novartis has lifted the curtain on new data from a Phase 3 trial investigating the efficacy of Entresto (sacubitril/valsartan) in preserving kidney function in patients with heart failure with reduced ejection fraction (HFrEF), demonstrating that those taking the drug experienced a slower rate of decline in estimated glomerular filtration rate (eGFR).
The study, which was the largest of its kind in heart failure, showed that non-diabetic patients with HFrEF experienced loss of kidney function at a rate twice as rapidly as the general population, and this rate was twice as fast again for HFrEF patients, or four times as fast as the general population. Entresto was shown to "significantly slow" the decline of function in all HFrEF patients compared to those treated with standard-of-care ACE inhibitor enalapril.
Additionally, it was shown that these benefits were doubled in patients who had both HFrEF and diabetes.
Data from the trial also showed that use of Entresto reduced the risk cardiovascular-related death by 20%, risk of all-cause death by 16%, and hospitalisations as a result of heart failure by 21%. Heart failure is linked to both kidney disease and diabetes, with more than half of such patients expected to develop the former and 40% expected to develop the latter, as well as an increased risk of morbidity and mortality.
"These results suggest that in addition to the established benefits on heart failure, Entresto treatment also helps to preserve kidney function. This is important because impaired kidney function is associated with poorer outcomes in patients with heart failure," explained Shreeram Aradhye, Chief Medical Officer and Global Head, Medical Affairs at Novartis. "The benefit is particularly significant for people with chronic heart failure who also have diabetes, which is an independent risk factor for kidney damage."
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