JAMA Cardiology reports post hoc analysis of effect of Entresto on social and physical activities of heart failure patients. - Novartis.

Novartis has 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. 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.

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.

See- Chandra, A, Lewis, EF, Claggett, BL, et al. The Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Heart Failure Patients: The PARADIGM-HF Trial. JAMA Cardiol. 2018.