The FINANCIAL -- Novartis on April 4 announced that JAMA Cardiology has published results from a post-hoc analysis demonstrating that treatment with Entresto (sacubitril/valsartan) significantly improved seven out of 10 types of physical and social activities at eight months in heart failure patients with reduced ejection fraction (HFrEF) versus previous standard of care.
The most significant improvements reported were in the ability to carry out household chores and the ability to conduct intimate/sexual relationships. The findings of the analysis are based on data from the PARADIGM-HF trial, the largest clinical trial ever conducted in heart failure.
"Chronic heart failure patients often experience a significant reduction in quality of life, even when compared to other chronic conditions," said Scott Solomon, MD, , Professor of Medicine, Brigham and Women's Hospital, Harvard Medical School, and senior author of the paper. "This analysis shows that treatment with Entresto can reduce limitations in physical and social activities that are important to heart failure patients, helping to preserve their independence, ability to go about their daily lives and maintain personal relationships."
These data examined the effect of treatment with Entresto on 10 activities related to specific physical and social limitations - which are two of the eight key components of health-related quality of life (HRQL) assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) - as reported by 7,623 patients enrolled in the PARADIGM-HF trial. Treatment with Entresto improved seven out of 10 of these activities at the pre-specified eight month analysis when compared with ACE inhibitor enalapril, with the most significant improvements reported in ability to carry out household chores and ability to conduct intimate/sexual relationships. The improvement in combined physical and social activity of patients treated with Entresto versus enalapril was equivalent to a difference of nine years of aging.Importantly, the physical and social improvements were observed from the eight-month visit, and were sustained during the study's three-year follow up period, according to Novartis.
"These results add to the growing body of evidence that, beyond reducing the risk of death and hospitalization, Entresto has a positive impact on the quality of life of heart failure patients," said Shreeram Aradhye, Chief Medical Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals. "Additionally, as the majority of patients in the PARADIGM-HF study were in the earlier stages of heart failure - NYHA class II - these data are an encouraging indication that Entresto may improve clinically important measures of quality of life, even in patients who do not yet suffer from the more severe symptoms of heart failure."
KCCQ is a self-administered HRQL measure specifically developed and validated for heart failure patients, with higher scores indicating fewer symptoms. This analysis explored the effects on treatment with Entresto on dressing, showering, climbing a flight of stairs, walking 100 yards, visiting family or friends, jogging, gardening, hobbies, doing household chores and intimate/sexual relationships. In PARADIGM-HF, Entresto was shown to reduce the risk of cardiovascular death or first heart failure hospitalization compared with enalapril.
These data were previously presented at the Heart Failure Society of America (HFSA) 21st Annual Scientific Meeting in Grapevine, Texas in September 2017.