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Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure
- Source :
- JAMA Cardiology. 3:498
- Publication Year :
- 2018
- Publisher :
- American Medical Association (AMA), 2018.
-
Abstract
- IMPORTANCE: Health-related quality of life (HRQL) of patients with heart failure is markedly reduced compared with that in patients with other chronic diseases, demonstrating substantial limitations in physical and social activities. In the Prospective Comparison of ARNI With an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial, sacubitril/valsartan improved overall HRQL compared with enalapril, as determined by the Kansas City Cardiomyopathy Questionnaire (KCCQ). OBJECTIVE: To examine the effects of sacubitril/valsartan on physical and social activities. DESIGN, SETTING, AND PARTICIPANTS: The PARADIGM-HF trial was a randomized, double-blind, active treatment–controlled clinical trial performed from December 8, 2009, to March 31, 2014, in 8399 patients with New York Heart Association class II to IV disease and a left ventricular ejection fraction of 40% or less at 1043 centers in 38 countries. Data analysis was performed from August 1, 2017, to December 25, 2017. INTERVENTIONS: Sacubitril/valsartan, 200 mg twice daily, or enalapril, 10 mg twice daily. MAIN OUTCOMES AND MEASURES: Patients completed HRQL assessments using the KCCQ at randomization, 4-month, 8-month, and annual visits. The effect of sacubitril/valsartan on components of the physical and social limitation sections of the KCCQ at 8 months and longitudinally and related biomarkers and clinical outcomes were studied. RESULTS: At baseline, 7618 of 8399 patients (90.7%) (mean [SD] age, 64 [11] years; 5987 [78.6%] male and 1631 [21.4%] female) completed the initial KCCQ assessment. Patients reported the greatest limitations at baseline in jogging and sexual relationships. Patients receiving sacubitril/valsartan had significantly better adjusted change scores in most physical and social activities at 8 months and during 36 months compared with those receiving enalapril. The largest improvement over enalapril was in household chores (adjusted change score difference, 2.35; 95% CI, 1.19-3.50; P
- Subjects :
- Male
medicine.medical_specialty
Tetrazoles
030204 cardiovascular system & hematology
Sacubitril
law.invention
Angiotensin Receptor Antagonists
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Enalapril
Quality of life
Randomized controlled trial
law
Internal medicine
Activities of Daily Living
medicine
Humans
030212 general & internal medicine
Social Behavior
Exercise
Aged
Original Investigation
Heart Failure
Ejection fraction
business.industry
Aminobutyrates
Biphenyl Compounds
Stroke Volume
Middle Aged
medicine.disease
Drug Combinations
Treatment Outcome
Valsartan
Heart failure
Quality of Life
Female
Cardiology and Cardiovascular Medicine
business
Sacubitril, Valsartan
medicine.drug
Subjects
Details
- ISSN :
- 23806583
- Volume :
- 3
- Database :
- OpenAIRE
- Journal :
- JAMA Cardiology
- Accession number :
- edsair.doi.dedup.....489a0cf0e1de5a4dc8921104a971d8b1
- Full Text :
- https://doi.org/10.1001/jamacardio.2018.0398