Heart Rate Control With If Inhibitor, Ivabradine, in Japanese Patients With Chronic Heart Failure - A Randomized, Double-Blind, Placebo-Controlled Phase II Study

Circulation Journal : Official Journal of the Japanese Circulation Society
Hiroyuki Tsutsuistudy investigators

Abstract

Elevated heart rate (HR) is an independent risk factor for cardiovascular outcomes in various cardiac diseases, including heart failure (HF). Randomized placebo-controlled study was conducted to evaluate the effects of ivabradine, an Ifinhibitor, 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. 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. (Circ J 2016; 80: 668-676).

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Citations

Jan 30, 2016·Circulation Journal : Official Journal of the Japanese Circulation Society·Tetsu Watanabe
Aug 23, 2016·Circulation Journal : Official Journal of the Japanese Circulation Society·Barry Greenberg
Nov 9, 2016·Journal of Immunology Research·Ilonka RohmAtilla Yilmaz
Aug 9, 2019·Circulation Journal : Official Journal of the Japanese Circulation Society·Hiroyuki TsutsuiUNKNOWN J-SHIFT Study Investigators
Sep 3, 2018·International Journal of Clinical Pharmacy·Camila HartmannCristina Pellegrino Baena
Jan 5, 2019·Circulation Journal : Official Journal of the Japanese Circulation Society·Tomomi IdeHiroyuki Tsutsui
Nov 5, 2020·The Cochrane Database of Systematic Reviews·Carina BenstoemVincent Brandenburg
Jul 20, 2021·International Heart Journal·Teruhiko Imamura, Koichiro Kinugawa
Oct 13, 2021·Canadian Journal of Physiology and Pharmacology·Noémi TóthNorbert Nagy

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