title: Heart Rate Control With If Inhibitor, Ivabradine, in Japanese Patients With Chronic Heart Failure　- A Randomized, Double-Blind, Placebo-Controlled Phase II Study.
abstract: BACKGROUND
  Elevated heart rate (HR) is an independent risk factor for cardiovascular outcomes in various cardiac diseases, including heart failure (HF).
  
  
  RESULTS
  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.
  
  
  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. (Circ J 2016; 80: 668-676).
authors.affiliation: Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsutsui
authors.forename: Shinichi
authors.initials: S
authors.lastname: Momomura
authors.forename: Akira
authors.initials: A
authors.lastname: Yamashina
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Shimokawa
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Kihara
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Saito
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Hagiwara
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ito
authors.forename: Junya
authors.initials: J
authors.lastname: Ako
authors.forename: Takayuki
authors.initials: T
authors.lastname: Inomata
authors.forename: Takashi
authors.initials: T
authors.lastname: Tanaka
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Kawasaki
mesh_terms: D000368:Aged; D001552:Benzazepines / Q000494:pharmacology*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology*; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D000077550:Ivabradine; D008297:Male; D008875:Middle Aged
chemical_list: D001552:Benzazepines; D000077550:Ivabradine