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March 15, 2021Circulation JournalOpen Access

Efficacy and Safety of Sacubitril/Valsartan in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction　― Results From the PARALLEL-HF Study ―

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Why the study?

Sacubitril/valsartan reduced CV death and HF hospitalization versus enalapril in PARADIGM-HF, but its efficacy and safety in Japanese HFrEF patients remained to be assessed.

Does sacubitril/valsartan reduce the composite outcome of cardiovascular death and heart failure hospitalization in Japanese patients with HFrEF compared to enalapril?

Population

225 Japanese HFrEF patients with NYHA class II-IV and LVEF ≤35%

Comparison

Sacubitril/valsartan 200 mg bid vs enalapril 10 mg bid

Design

Prospective randomized trial

Follow-up

Median 33.9 months

Discussion

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Overview

May support ARNI in select HFrEF cohorts; leaves open confirmation by randomized trials before practice change.

Key Points

  • Evaluate the efficacy and safety of sacubitril/valsartan compared with enalapril in Japanese patients with chronic heart failure and reduced ejection fraction.
  • Randomized 225 Japanese patients (1:1) with HFrEF (NYHA class II–IV, LVEF ≤35%) to sacubitril/valsartan 200 mg bid or enalapril 10 mg bid.
  • Followed patients over a median duration of 33.9 months to monitor clinical outcomes and biomarker changes.
  • No significant difference occurred in the primary composite outcome of cardiovascular death and heart failure hospitalization (HR 1.09; 95% CI 0.65–1.82; P=0.6260).
  • Sacubitril/valsartan produced greater reductions in NT-proBNP compared with enalapril at Week 2 (25.7% difference, P<0.01) and Month 6 (18.9% difference, P=0.01).
  • Adverse event discontinuations were lower with sacubitril/valsartan, although hypotension was reported in a higher proportion of patients.

Structured PICO

Does sacubitril/valsartan reduce the composite outcome of cardiovascular death and heart failure hospitalization in Japanese patients with HFrEF compared to enalapril?

P
Population
225 Japanese patients with chronic heart failure and reduced ejection fraction (HFrEF), NYHA class II-IV, LVEF ≤35%
I
Intervention
Sacubitril/valsartan 200 mg bid
C
Comparator
Enalapril 10 mg bid
O
Outcome
Composite outcome of cardiovascular (CV) death and heart failure (HF) hospitalizationcomposite

In Japanese patients with HFrEF, sacubitril/valsartan did not significantly reduce the risk of cardiovascular death or heart failure hospitalization compared to enalapril, though it did significantly reduce NT-proBNP levels.

Cite This Study

A 2021 study studied this question.

synapsesocial.com/papers/6a7d5bccfd19755b5e278745https://doi.org/10.1253/circj.cj-20-0854
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Efficacy and Safety of Sacubitril/Valsartan Versus Enalapril in the Treatment of Heart Failure With Reduced Ejection Fraction: A Systematic Review and Meta-Analysis2026
  2. 2Effects of sacubitril/valsartan on clinical symptoms, echocardiographic parameters, and outcomes in HFrEF and HFmrEF patients with coronary heart disease and chronic kidney disease2021 · 8 citations
  3. 3Efficacy and Safety of Sacubitril/Valsartan in Japanese Patients With Heart Failure According to Baseline Systolic Blood Pressure ― Results From a Subgroup Analysis of the PARALLEL-HF Study ―2023 · 8 citations
  4. 4Effect of Treatment With Sacubitril/Valsartan in Patients With Advanced Heart Failure and Reduced Ejection Fraction2021 · 179 citations
  5. 5Real-world safety of sacubitril/valsartan in Japanese patients with chronic heart failure: A post-marketing surveillance study2025 · 1 citations