Heart Rate Control With If Inhibitor, Ivabradine, in Japanese Patients With Chronic Heart Failure - A Randomized, Double-Blind, Placebo-Controlled Phase II Study.
Circ J. 2016 Jan 14;
Authors: Tsutsui H, Momomura S, Yamashina A, Ogawa H, Shimokawa H, Kihara Y, Saito Y, Hagiwara N, Ito H, Ako J, Inomata T, Tanaka T, Kawasaki Y, study investigators
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 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.
PMID: 26763489 [PubMed - as supplied by publisher]