Heart Rate Control With If Inhibitor, Ivabradine, in Japanese Patients With Chronic Heart Failure - A Randomized,
Hiroyuki Tsutsui1, Shinichi Momomura, Akira Yamashina
1Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine.
Insights
Ivabradine effectively lowered resting heart rate in Japanese heart failure patients. A starting dose of 2.5 mg twice daily may offer a safer profile compared to 5 mg BID.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Elevated heart rate (HR) is a significant risk factor for adverse cardiovascular outcomes in heart failure (HF).
- Managing HR is crucial for improving prognosis in HF patients.
Purpose of the Study:
- To evaluate the efficacy and safety of ivabradine, an If inhibitor, in reducing resting HR.
- To assess different starting doses of ivabradine in Japanese symptomatic HF patients.
Main Methods:
- A 6-week, randomized, placebo-controlled study involving 126 Japanese HF patients.
- Patients received placebo, 2.5 mg ivabradine BID, or 5 mg ivabradine BID, with potential dose adjustments.
- Inclusion criteria included LVEF ≤35% and resting HR ≥75 bpm.
Main Results:
- Both 2.5 mg and 5 mg BID doses of ivabradine significantly reduced resting HR compared to placebo (16.6 and 16.4 bpm reduction, respectively).
- The most common side effect was mild phosphenes.
- One patient discontinued treatment due to HF in the 5 mg group.
Conclusions:
- Ivabradine, initiated at 2.5 mg or 5 mg BID, effectively reduces resting HR in Japanese HF patients.
- A starting dose of 2.5 mg BID may be associated with a safer side effect profile.
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. (Circ J 2016; 80: 668-676).
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