Skip to main content
Journal cover image

Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.

Publication ,  Journal Article
Berg, DD; Braunwald, E; DeVore, AD; Lala, A; Pinney, SP; Duffy, CI; Gurmu, Y; Velazquez, EJ; Morrow, DA
Published in: JACC Heart Fail
October 2020

OBJECTIVES: This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial. BACKGROUND: In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest. METHODS: PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability. RESULTS: At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (pinteraction = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (pinteraction = 0.42), or the pre-specified adverse events of special interest through 8 weeks. CONCLUSIONS: In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

October 2020

Volume

8

Issue

10

Start / End Page

834 / 843

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Valsartan
  • Stroke Volume
  • Humans
  • Heart Failure
  • Female
  • Drug Combinations
  • Biphenyl Compounds
  • Angiotensin-Converting Enzyme Inhibitors
  • Angiotensin Receptor Antagonists
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Berg, D. D., Braunwald, E., DeVore, A. D., Lala, A., Pinney, S. P., Duffy, C. I., … Morrow, D. A. (2020). Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial. JACC Heart Fail, 8(10), 834–843. https://doi.org/10.1016/j.jchf.2020.06.008
Berg, David D., Eugene Braunwald, Adam D. DeVore, Anuradha Lala, Sean P. Pinney, Carol I. Duffy, Yared Gurmu, Eric J. Velazquez, and David A. Morrow. “Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.JACC Heart Fail 8, no. 10 (October 2020): 834–43. https://doi.org/10.1016/j.jchf.2020.06.008.
Berg DD, Braunwald E, DeVore AD, Lala A, Pinney SP, Duffy CI, et al. Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial. JACC Heart Fail. 2020 Oct;8(10):834–43.
Berg, David D., et al. “Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.JACC Heart Fail, vol. 8, no. 10, Oct. 2020, pp. 834–43. Pubmed, doi:10.1016/j.jchf.2020.06.008.
Berg DD, Braunwald E, DeVore AD, Lala A, Pinney SP, Duffy CI, Gurmu Y, Velazquez EJ, Morrow DA. Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial. JACC Heart Fail. 2020 Oct;8(10):834–843.
Journal cover image

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

October 2020

Volume

8

Issue

10

Start / End Page

834 / 843

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Valsartan
  • Stroke Volume
  • Humans
  • Heart Failure
  • Female
  • Drug Combinations
  • Biphenyl Compounds
  • Angiotensin-Converting Enzyme Inhibitors
  • Angiotensin Receptor Antagonists