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Angiotensin–Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual), Universidade de São Paulo (USP), instacron:USP, New England Journal of Medicine, 381(17), 1609-1620. MASSACHUSETTS MEDICAL SOC
- Publication Year :
- 2019
-
Abstract
- Background: \ud The angiotensin receptor–neprilysin inhibitor sacubitril–valsartan led to a reduced risk of hospitalization for heart failure or death from cardiovascular causes among patients with heart failure and reduced ejection fraction. The effect of angiotensin receptor–neprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear.\ud \ud Methods: \ud We randomly assigned 4822 patients with New York Heart Association (NYHA) class II to IV heart failure, ejection fraction of 45% or higher, elevated level of natriuretic peptides, and structural heart disease to receive sacubitril–valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or valsartan (target dose, 160 mg twice daily). The primary outcome was a composite of total hospitalizations for heart failure and death from cardiovascular causes. Primary outcome components, secondary outcomes (including NYHA class change, worsening renal function, and change in Kansas City Cardiomyopathy Questionnaire [KCCQ] clinical summary score [scale, 0 to 100, with higher scores indicating fewer symptoms and physical limitations]), and safety were also assessed.\ud \ud Results: \ud There were 894 primary events in 526 patients in the sacubitril–valsartan group and 1009 primary events in 557 patients in the valsartan group (rate ratio, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P=0.06). The incidence of death from cardiovascular causes was 8.5% in the sacubitril–valsartan group and 8.9% in the valsartan group (hazard ratio, 0.95; 95% CI, 0.79 to 1.16); there were 690 and 797 total hospitalizations for heart failure, respectively (rate ratio, 0.85; 95% CI, 0.72 to 1.00). NYHA class improved in 15.0% of the patients in the sacubitril–valsartan group and in 12.6% of those in the valsartan group (odds ratio, 1.45; 95% CI, 1.13 to 1.86); renal function worsened in 1.4% and 2.7%, respectively (hazard ratio, 0.50; 95% CI, 0.33 to 0.77). The mean change in the KCCQ clinical summary score at 8 months was 1.0 point (95% CI, 0.0 to 2.1) higher in the sacubitril–valsartan group. Patients in the sacubitril–valsartan group had a higher incidence of hypotension and angioedema and a lower incidence of hyperkalemia. Among 12 prespecified subgroups, there was suggestion of heterogeneity with possible benefit with sacubitril–valsartan in patients with lower ejection fraction and in women.\ud \ud Conclusions: \ud Sacubitril–valsartan did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among patients with heart failure and an ejection fraction of 45% or higher. (Funded by Novartis; PARAGON-HF ClinicalTrials.gov number, NCT01920711.)
- Subjects :
- Male
MIDRANGE
MIDDLE CHILD
Tetrazoles
Insuficiència cardíaca
Sex Factor
030204 cardiovascular system & hematology
Hospital patients
0302 clinical medicine
Cardiovascular Disease
Single-Blind Method
030212 general & internal medicine
Neprilysin
Tetrazole
Angiotensin Receptor Antagonists
Aminobutyrates
Angiotensin Receptor Antagonist
IMPAIRED SYSTOLIC FUNCTION
General Medicine
Stroke volume
Middle Aged
SPIRONOLACTONE
Hospitalization
Drug Combinations
HIPOTENSÃO
Valsartan
Cardiovascular Diseases
Cardiology
Female
Hypotension
medicine.drug
Human
Angiotensines
medicine.medical_specialty
Angiotensins
Aminobutyrate
Aged
Angioedema
Double-Blind Method
Follow-Up Studies
Heart Failure
Humans
Quality of Life
Sex Factors
Stroke Volume
Heart failure
Follow-Up Studie
03 medical and health sciences
Internal medicine
Renin–angiotensin system
medicine
Mortalitat
Mortality
Malalts hospitalitzats
business.industry
fungi
medicine.disease
business
Heart failure with preserved ejection fraction
Sacubitril, Valsartan
Subjects
Details
- Language :
- English
- ISSN :
- 00284793
- Database :
- OpenAIRE
- Journal :
- Dipòsit Digital de la UB, Universidad de Barcelona, Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual), Universidade de São Paulo (USP), instacron:USP, New England Journal of Medicine, 381(17), 1609-1620. MASSACHUSETTS MEDICAL SOC
- Accession number :
- edsair.doi.dedup.....c4eefe59348013f3ae5a9a210b4602d9