Heart rate control with if inhibitor, ivabradine, in Japanese patients with chronic heart failure–A randomized, double-blind, placebo-controlled phase II study–

The study investigators

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: Elevated heart rate (HR) is an independent risk factor for cardiovascular outcomes in various cardiac diseases, including heart failure (HF). Methods and Results: Randomized placebo-controlled study was conducted to evaluate the effects of ivabradine, an If inhibitor, on the resting HR in 126 Japanese symptomatic HF patients with left ventricular ejection fraction ≤35%, resting HR ≥75 beats/min in sinus rhythm, and stable, optimal background treatment. Patients were randomly allocated into 3 groups: placebo; starting dose of ivabradine 2.5 mg twice daily (BID; 2.5 mg group 5 mg BID group. The dose was increased up to 7.5 mg BID according to dose-adjustment criteria. After the 6-week treatment, the reductions in resting HR were significant in both the 2.5-mg (16.6±8.1 beats/min) and 5-mg (16.4±9.6 beats/min) groups (P<0.0001 for both groups) compared with placebo (1.7±8.7 beats/min). The most frequent side effect of ivabradine was phosphenes, but all were mild. Treatment was discontinued in 1 patient due to HF in the 5 mg group. Conclusions: Ivabradine starting at 2.5 or 5 mg BID effectively reduced resting HR in Japanese HF patients. Ivabradine at the starting dose of 2.5 mg BID could be safer than 5 mg BID.

Original languageEnglish
Pages (from-to)668-676
Number of pages9
JournalCirculation Journal
Volume80
Issue number3
DOIs
Publication statusPublished - Feb 25 2016

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ivabradine
Heart Rate
Placebos
Heart Failure
Phosphenes
Social Adjustment
Stroke Volume
Heart Diseases
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Heart rate control with if inhibitor, ivabradine, in Japanese patients with chronic heart failure–A randomized, double-blind, placebo-controlled phase II study–. / The study investigators.

In: Circulation Journal, Vol. 80, No. 3, 25.02.2016, p. 668-676.

Research output: Contribution to journalArticle

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abstract = "Background: Elevated heart rate (HR) is an independent risk factor for cardiovascular outcomes in various cardiac diseases, including heart failure (HF). Methods and Results: Randomized placebo-controlled study was conducted to evaluate the effects of ivabradine, an If inhibitor, on the resting HR in 126 Japanese symptomatic HF patients with left ventricular ejection fraction ≤35{\%}, resting HR ≥75 beats/min in sinus rhythm, and stable, optimal background treatment. Patients were randomly allocated into 3 groups: placebo; starting dose of ivabradine 2.5 mg twice daily (BID; 2.5 mg group 5 mg BID group. The dose was increased up to 7.5 mg BID according to dose-adjustment criteria. After the 6-week treatment, the reductions in resting HR were significant in both the 2.5-mg (16.6±8.1 beats/min) and 5-mg (16.4±9.6 beats/min) groups (P<0.0001 for both groups) compared with placebo (1.7±8.7 beats/min). The most frequent side effect of ivabradine was phosphenes, but all were mild. Treatment was discontinued in 1 patient due to HF in the 5 mg group. Conclusions: Ivabradine starting at 2.5 or 5 mg BID effectively reduced resting HR in Japanese HF patients. Ivabradine at the starting dose of 2.5 mg BID could be safer than 5 mg BID.",
author = "{The study investigators} and Hiroyuki Tsutsui and Shinichi Momomura and Akira Yamashina and Hisao Ogawa and Hiroaki Shimokawa and Yasuki Kihara and Yoshihiko Saito and Nobuhisa Hagiwara and Hiroshi Ito and Junya Ako and Takayuki Inomata and Takashi Tanaka and Yasushi Kawasaki",
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AU - The study investigators

AU - Tsutsui, Hiroyuki

AU - Momomura, Shinichi

AU - Yamashina, Akira

AU - Ogawa, Hisao

AU - Shimokawa, Hiroaki

AU - Kihara, Yasuki

AU - Saito, Yoshihiko

AU - Hagiwara, Nobuhisa

AU - Ito, Hiroshi

AU - Ako, Junya

AU - Inomata, Takayuki

AU - Tanaka, Takashi

AU - Kawasaki, Yasushi

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N2 - Background: Elevated heart rate (HR) is an independent risk factor for cardiovascular outcomes in various cardiac diseases, including heart failure (HF). Methods and Results: Randomized placebo-controlled study was conducted to evaluate the effects of ivabradine, an If inhibitor, on the resting HR in 126 Japanese symptomatic HF patients with left ventricular ejection fraction ≤35%, resting HR ≥75 beats/min in sinus rhythm, and stable, optimal background treatment. Patients were randomly allocated into 3 groups: placebo; starting dose of ivabradine 2.5 mg twice daily (BID; 2.5 mg group 5 mg BID group. The dose was increased up to 7.5 mg BID according to dose-adjustment criteria. After the 6-week treatment, the reductions in resting HR were significant in both the 2.5-mg (16.6±8.1 beats/min) and 5-mg (16.4±9.6 beats/min) groups (P<0.0001 for both groups) compared with placebo (1.7±8.7 beats/min). The most frequent side effect of ivabradine was phosphenes, but all were mild. Treatment was discontinued in 1 patient due to HF in the 5 mg group. Conclusions: Ivabradine starting at 2.5 or 5 mg BID effectively reduced resting HR in Japanese HF patients. Ivabradine at the starting dose of 2.5 mg BID could be safer than 5 mg BID.

AB - Background: Elevated heart rate (HR) is an independent risk factor for cardiovascular outcomes in various cardiac diseases, including heart failure (HF). Methods and Results: Randomized placebo-controlled study was conducted to evaluate the effects of ivabradine, an If inhibitor, on the resting HR in 126 Japanese symptomatic HF patients with left ventricular ejection fraction ≤35%, resting HR ≥75 beats/min in sinus rhythm, and stable, optimal background treatment. Patients were randomly allocated into 3 groups: placebo; starting dose of ivabradine 2.5 mg twice daily (BID; 2.5 mg group 5 mg BID group. The dose was increased up to 7.5 mg BID according to dose-adjustment criteria. After the 6-week treatment, the reductions in resting HR were significant in both the 2.5-mg (16.6±8.1 beats/min) and 5-mg (16.4±9.6 beats/min) groups (P<0.0001 for both groups) compared with placebo (1.7±8.7 beats/min). The most frequent side effect of ivabradine was phosphenes, but all were mild. Treatment was discontinued in 1 patient due to HF in the 5 mg group. Conclusions: Ivabradine starting at 2.5 or 5 mg BID effectively reduced resting HR in Japanese HF patients. Ivabradine at the starting dose of 2.5 mg BID could be safer than 5 mg BID.

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