Novartis announced today new real world evidence from the CHAMP-HF registry comparing Entresto® (sacubitril/valsartan) patients to patients not taking Entresto.[1] This pre-specified analysis of an interim data cut from the CHAMP-HF registry showed that chronic heart failure (HF) patients with reduced ejection fraction (HFrEF) taking Entresto reported early, statistically significant improvement in health status, as measured by the KCCQ-12 overall summary score (KCCQ-OS). [1] This finding was driven by statistically significant improvements in symptom frequency and quality of life domains of the KCCQ-12.[1] The study findings were presented today by lead investigator Yevgeniy Khariton, MD, MSc, Saint Luke's Hospital, Mid-America Heart Institute, University of Missouri-Kansas City, as a part of a late-breaking session at the European Society of Cardiology Heart Failure (ESC-HF) Congress in Vienna, Austria.
"Key goals in managing chronic heart failure are to improve patients' symptoms and quality of life," said CHAMP-HF Chair Gregg C. Fonarow, MD and Director of the Ahmanson-UCLA Cardiomyopathy Center, Co-Chief of UCLA's Division of Cardiology, and Co-director of UCLA's Preventative Cardiology Program. "These findings in a real world setting are important because they suggest that taking sacubitril/valsartan may help patients achieve these goals."
"In addition to the already reported reduction in risk of cardiovascular death and heart failure hospitalization in HFrEF patients treated with Entresto, we now show its potential to improve patient-reported health status," said Shreeram Aradhye, MD, Chief Medical Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals. "What we find most encouraging is that both our Entresto clinical program and now this real world analysis have shown health status benefits as measured by KCCQ."
About Heart Failure
Heart failure is a debilitating and life-threatening condition, which impacts millions of people worldwide.[14] It is the leading cause of hospitalization in people over the age of 65.[8],[15], About half of people with heart failure have heart failure with reduced ejection fraction (HFrEF).[9] Reduced ejection fraction means the heart does not contract with enough force, so less blood is pumped out.[11] Heart failure presents a major and growing health-economic burden that currently costs the world economy $108 billion every year, which accounts for both direct and indirect costs.[15],[12]
Novartis has established the largest global clinical program in the heart failure disease area across the pharma industry to date, FortiHFy, comprising over 40 active or planned clinical studies designed to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real world evidence with Entresto, as well as to extend understanding of heart failure.
About Entresto® (sacubitril/valsartan)
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).[16],[13] 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.[16] Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.[10]
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.[10] 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.[17] Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker (ARB).[10] Approved indications may vary depending upon the individual country.
About KCCQ-12
KCCQ-12 is a self-administered, health status tool for patients with hea...
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