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Long-Term Treatment With Sacubitril/Valsartan in Japanese Patients With Chronic Heart Failure and Reduced Ejection

Hiroyuki Tsutsui1, Shin-Ichi Momomura2, Yoshihiko Saito3

  • 1Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University.

Circulation Journal : Official Journal of the Japanese Circulation Society
|August 27, 2023
PubMed

Insights

Long-term use of sacubitril/valsartan in Japanese patients with heart failure with reduced ejection fraction (HFrEF) demonstrated a favorable safety profile. The treatment was well-tolerated and showed no worsening of heart failure symptoms.

Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • The PARALLEL-HF study investigated sacubitril/valsartan versus enalapril in Japanese patients with chronic heart failure with reduced ejection fraction (HFrEF).
  • This open-label extension (OLE) specifically evaluated the long-term safety and tolerability of sacubitril/valsartan.

Purpose of the Study:

  • To assess the long-term safety and tolerability of sacubitril/valsartan in Japanese patients with HFrEF.
  • To evaluate the risk-benefit profile of sacubitril/valsartan in this patient population over an extended period.

Main Methods:

  • 150 patients received sacubitril/valsartan (50 or 100 mg, b.i.d.), with a target dose of 200 mg, b.i.d., by Week 8.
  • Cardiac biomarkers (BNP, NT-proBNP, urine cGMP) were monitored. Patients were categorized into sacubitril/valsartan core and enalapril core groups.
  • Mean exposure to study drug was 98.9% over the study duration.

Main Results:

  • No trend of worsening heart failure (HF) was observed at Month 12.
  • Cardiac biomarkers showed no significant changes in the sacubitril/valsartan group.
  • The enalapril core group exhibited increases in BNP and urine cGMP, and a decrease in NT-proBNP from Weeks 2-4 to Month 12.

Conclusions:

  • Long-term administration of sacubitril/valsartan, up to 200 mg b.i.d., is safe and well-tolerated in Japanese patients with chronic HFrEF.
  • The drug demonstrated a positive risk-benefit profile in this population.
  • No adverse cardiac events or worsening HF were noted during the extension study.
Abstract

Keywords:
HFrEFJapanSacubitril/valsartanSafety

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