What is the use of Ivabradine (Procoralan)?

From the Guidelines

Ivabradine should be considered for patients with heart failure with reduced ejection fraction (HFrEF) who are in sinus rhythm with a resting heart rate of 70 beats per minute or higher, despite optimal medical therapy, as it has been shown to reduce hospitalizations and improve quality of life 1.

Key Points

• Ivabradine works by selectively inhibiting the "funny" channel (If) in the sinoatrial node, slowing the heart rate without affecting blood pressure or cardiac contractility.
• The typical starting dose is 5 mg twice daily, which may be adjusted to 2.5-7.5 mg twice daily based on heart rate response, aiming for a resting heart rate between 50-60 beats per minute.
• Ivabradine is indicated for patients with HFrEF who have a left ventricular ejection fraction of 35% or less, are in sinus rhythm with a resting heart rate of 70 beats per minute or higher, and remain symptomatic despite optimal medical therapy, including a beta-blocker at maximum tolerated dose 1.

Important Considerations

• Common side effects include visual brightness disturbances (phosphenes), bradycardia, and atrial fibrillation.
• Ivabradine should not be used in patients with severe liver disease, pacemaker-dependent rhythm, or alongside strong CYP3A4 inhibitors.
• The benefit of ivabradine was driven by a reduction in HF hospitalization, as demonstrated in the SHIFT trial, which included patients with HFrEF and left ventricular ejection fraction ≤35%, in sinus rhythm with a resting heart rate of ≥70 beats per minute 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Ivabradine Overview

• Ivabradine is a selective and specific inhibitor of If current, used to optimize heart rate in patients with chronic systolic heart failure 2.
• It is recommended by European Society of Cardiology and American College of Cardiology/American Heart Association guidelines for symptomatic heart failure patients with ejection fraction 35% or less, sinus rhythm, and heart rate at least 70 bpm, despite maximally titrated β-blocker therapy 2.

Indications and Eligibility

• Ivabradine is indicated for patients with heart failure with reduced ejection fraction (HFrEF) who are on optimal guideline-directed medical therapy (GDMT) but still have a heart rate ≥70 bpm 2.
• In a study of 308 patients with HFrEF, ivabradine was indicated in 52 patients (16.8%) who met the eligibility criteria 2.
• Ivabradine has also been used to treat inappropriate sinus tachycardia (IST), with studies showing significant reductions in heart rate and improvements in symptoms 3, 4.

Mechanism of Action and Effects

• Ivabradine works by inhibiting the If current in the sinoatrial node, slowing the heart rate without affecting blood pressure or cardiac contractility 5.
• It has been shown to reduce cardiac remodeling, improve exercise tolerance, and enhance quality of life in patients with heart failure 5.
• Ivabradine has also been associated with reduced heart rate variability and improved New York Heart Association (NYHA) functional class 5.

Clinical Evidence and Guidelines

• The SHIFT study demonstrated the efficacy of ivabradine in reducing hospitalizations and deaths in patients with chronic heart failure 2, 5.
• The 2016 European Society of Cardiology (ESC) guidelines recommend ivabradine for symptomatic HF patients with left ventricular ejection fraction ≤35% and heart rate higher than 70 beats per minute, despite optimal medical therapy 6.
• Ivabradine has also been included in the treatment of angina pectoris with heart failure in the 2016 ESC guidelines 6.