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Novartis PARADIGM-HF phase III study of Entresto helps to preserve kidney function in heart failure patients with diabetes

Tuesday, April 17, 2018, 09:00 Hrs  [IST]

Novartis announced a new post hoc analysis of the pivotal phase III heart failure study, PARADIGM-HF, demonstrating that treatment with Entresto (sacubitril/valsartan) helped to preserve kidney function, as assessed by estimated glomerular filtration rate (eGFR), in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril. In a sub group of patients who had both HFrEF and diabetes, the magnitude of benefit was twice as high. The findings of the analysis are published in The Lancet Diabetes & Endocrinology.

"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," said Shreeram Aradhye, chief medical officer and global head, medical affairs, Novartis Pharmaceuticals. "The benefit is particularly significant for people with chronic heart failure who also have diabetes, which is an independent risk factor for kidney damage."

Non-diabetic HFrEF patients in the PARADIGM-HF study were shown to lose kidney function twice as fast as the general population. This was further accelerated in HFrEF patients with diabetes, who experienced a decline in kidney function that was twice as fast as the non-diabetic patients. When compared with enalapril, treatment with Entresto significantly slowed this decline in all HFrEF patients (-1.3 vs -1.8 ml/min/1.73m per year).In HFrEF patients who also had diabetes, the benefit of treatment with Entresto was doubled vs. those without diabetes (+0.6 (0.4, 0.8) vs. +0.3 (0.2, 0.5) ml/min/1.73m per year).  

Heart failure is associated with both diabetes and kidney disease, which lead to poorer outcomes for patients, including increased risk of morbidity and mortality. More than half of all heart failure patients are expected to experience moderate to severe chronic kidney disease (CKD), and up to 40% of heart failure patients will have a diagnosis of diabetes. Diabetes significantly increases an individual's risk for CKD. Added to this, many anti-diabetic medications are known to increase the risk of heart failure hospitalization or mortality.

Primary data from PARADIGM-HF, the largest clinical trial ever conducted in heart failure, showed that treatment with Entresto reduced the risk of dying from a cardiovascular cause by 20%, reduced heart failure hospitalizations by 21% and reduced the risk of dying from any cause by 16% as compared to enalapril. This new analysis adds to the growing evidence that Entresto has important clinical benefits for heart failure patients beyond improving their cardiovascular outcomes, and validates findings from a further post hoc analysis of PARADIGM-HF, published online in the Journal of the American College of Cardiology: Heart failure (JACC-HF) on 12 April 2018, which found that Entresto helped slow the rate of renal function decline, even in heart failure patients with chronic kidney disease, as compared to enalapril. Entresto is indicated for the treatment of chronic heart failure (NYHA II-IV) with reduced ejection fraction. It is not indicated to treat diabetes.

Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Other common heart failure medicines, called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.

In Europe, Entresto is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction. In the United States, Entresto is indicated for the treatment of heart failure (New York Heart Association class II-IV) in patients with systolic dysfunction. It has been shown to reduce the rate of cardiovascular death and heart failure hospitalization compared to enalapril, and also to reduce the rate of all-cause mortality compared to enalapril. Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB). Approved indications may vary depending upon the individual country.


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