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充血性心力衰竭

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Clinical TrialSeptember 1, 2019

JOURNAL:N Engl J Med. Article Link

Angiotensin–Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction

SD Solomon, the PARAGON-HF Investigators and Committees. JohnJV McMurray, Keywords: HFpEF; HFmEF; angiotensin receptor–neprilysin inhibitor; sacubitril–valsartan vs valsartan; hospitalization; cardiovascular death; women

ABSTRACT


BACKGROUND - The angiotensin receptorneprilysin inhibitor sacubitrilvalsartan 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 receptorneprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear.

 

METHODS - 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 sacubitrilvalsartan (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.

 

RESULTS - There were 894 primary events in 526 patients in the sacubitrilvalsartan 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 sacubitrilvalsartan 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 sacubitrilvalsartan 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 sacubitrilvalsartan group. Patients in the sacubitrilvalsartan 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 sacubitrilvalsartan in patients with lower ejection fraction and in women.

 

CONCLUSIONS - Sacubitrilvalsartan 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.)