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November 3, 2021JAMA CardiologyOpen Access

Effect of Treatment With Sacubitril/Valsartan in Patients With Advanced Heart Failure and Reduced Ejection Fraction

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Why the study?

Practice guidelines do not endorse sacubitril/valsartan for patients with NYHA class IV HFrEF due to limited clinical experience in this population.

Does sacubitril/valsartan reduce NT-proBNP levels compared to valsartan in patients with advanced heart failure and reduced ejection fraction?

Population

335 patients with advanced HFrEF and recent NYHA class IV symptoms

Comparison

Sacubitril/valsartan vs valsartan

Design

Double-blind randomized clinical trial

Follow-up

24 weeks

Authors

DMDouglas L. MannMGMichael M. GivertzJVJustin Vader

Discussion

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Member takes

Overview

Does not support NT-proBNP reduction with sacubitril/valsartan versus valsartan in advanced HFrEF; challenges extrapolation from milder cohorts.

Structured PICO

Does sacubitril/valsartan reduce NT-proBNP levels compared to valsartan in patients with advanced heart failure and reduced ejection fraction?

P
Population
335 patients with advanced heart failure and reduced ejection fraction and recent New York Heart Association class IV symptoms, mean age 59.4 years, 73% men.
I
Intervention
Sacubitril/valsartan (target dose, 200 mg twice daily) in addition to recommended therapy
C
Comparator
Valsartan (target dose, 160 mg twice daily) in addition to recommended therapy
O
Outcome
Area under the curve (AUC) for the ratio of N-terminal pro-brain natriuretic peptide (NT-proBNP) compared with baseline measured through 24 weeks of therapysurrogate

In patients with advanced HFrEF and recent NYHA class IV symptoms, sacubitril/valsartan did not significantly reduce NT-proBNP levels compared with valsartan over 24 weeks.

Limitations

  • Stopped early owing to COVID-19 risk

Cite This Study

Mann et al. (2021) studied this question.

synapsesocial.com/papers/6a837df00fbb7e2b20d408e2https://doi.org/10.1001/jamacardio.2021.4567
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