Efficacy and safety of ivabradine in Japanese patients with chronic heart failure ― J-SHIFT study ―

behalf of the J-SHIFT Study Investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, an If inhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF. Methods and Results: Patients with NYHA functional class II-IV, left ventricular EF ≤35%, and resting HR ≥75beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5%) patients in the ivabradine group and 37 (29.1%) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95% CI 0.40-1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3%) patients in the ivabradine group and 4 (3.1%) patients in the placebo group (P=0.3760). Conclusions: The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.

Original languageEnglish
Pages (from-to)2049-2060
Number of pages12
JournalCirculation Journal
Volume83
Issue number10
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

ivabradine
Heart Failure
Safety
Placebos
Heart Rate
Phosphenes
Bradycardia

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Efficacy and safety of ivabradine in Japanese patients with chronic heart failure ― J-SHIFT study ―. / behalf of the J-SHIFT Study Investigators.

In: Circulation Journal, Vol. 83, No. 10, 01.01.2019, p. 2049-2060.

Research output: Contribution to journalArticle

behalf of the J-SHIFT Study Investigators. / Efficacy and safety of ivabradine in Japanese patients with chronic heart failure ― J-SHIFT study ―. In: Circulation Journal. 2019 ; Vol. 83, No. 10. pp. 2049-2060.
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abstract = "Background: Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, an If inhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF. Methods and Results: Patients with NYHA functional class II-IV, left ventricular EF ≤35{\%}, and resting HR ≥75beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5{\%}) patients in the ivabradine group and 37 (29.1{\%}) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95{\%} CI 0.40-1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3{\%}) patients in the ivabradine group and 4 (3.1{\%}) patients in the placebo group (P=0.3760). Conclusions: The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.",
author = "{behalf of the J-SHIFT Study Investigators} and Hiroyuki Tsutsui and Momomura, {Shin Ichi} and Akira Yamashina and Hiroaki Shimokawa and Yasuki Kihara and Yoshihiko Saito and Nobuhisa Hagiwara and Hiroshi Ito and Masafumi Yano and Kazuhiro Yamamoto and Junya Ako and Takayuki Inomata and Yasushi Sakata and Takashi Tanaka and Yasushi Kawasaki",
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T1 - Efficacy and safety of ivabradine in Japanese patients with chronic heart failure ― J-SHIFT study ―

AU - behalf of the J-SHIFT Study Investigators

AU - Tsutsui, Hiroyuki

AU - Momomura, Shin Ichi

AU - Yamashina, Akira

AU - Shimokawa, Hiroaki

AU - Kihara, Yasuki

AU - Saito, Yoshihiko

AU - Hagiwara, Nobuhisa

AU - Ito, Hiroshi

AU - Yano, Masafumi

AU - Yamamoto, Kazuhiro

AU - Ako, Junya

AU - Inomata, Takayuki

AU - Sakata, Yasushi

AU - Tanaka, Takashi

AU - Kawasaki, Yasushi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, an If inhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF. Methods and Results: Patients with NYHA functional class II-IV, left ventricular EF ≤35%, and resting HR ≥75beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5%) patients in the ivabradine group and 37 (29.1%) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95% CI 0.40-1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3%) patients in the ivabradine group and 4 (3.1%) patients in the placebo group (P=0.3760). Conclusions: The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.

AB - Background: Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, an If inhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF. Methods and Results: Patients with NYHA functional class II-IV, left ventricular EF ≤35%, and resting HR ≥75beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5%) patients in the ivabradine group and 37 (29.1%) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95% CI 0.40-1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3%) patients in the ivabradine group and 4 (3.1%) patients in the placebo group (P=0.3760). Conclusions: The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.

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U2 - 10.1253/circj.CJ-19-0227

DO - 10.1253/circj.CJ-19-0227

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C2 - 31391387

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VL - 83

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JO - Circulation Journal

JF - Circulation Journal

SN - 1346-9843

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