伊伐布雷定(Ivabradine)是哪类药？

Ivabradine is a class of drugs that reduce sinus rhythm and is an inhibitor of hyperpolarization-activated cyclic nucleotide-gated (HCN) channels. It is currently approved for the treatment of coronary artery disease and chronic heart failure. Once-daily Ivabradine can improve patients' cardiac function.

What is Ivabradine?

It is a unique drug approved in the United States and is a selective heart rate reducer. It is approved in the United States for adjunctive treatment in patients with heart failure with reduced ejection fraction.

Ivabradine was first approved as an anti-angina drug in many countries around the world more than ten years ago, and was subsequently approved for use in patients with heart failure. Because Ivabradine has the activity of selectively blocking the If current in the sinoatrial node, it can reduce heart rate without significant effects on blood pressure.

Numerous clinical studies have shown that ivabradine improves clinical outcomes and quality of life and reduces the risk of death from heart failure (HF) or other cardiovascular diseases.

In addition, ivabradine may be used to treat inappropriate sinus tachycardia in patients who are often intolerant to beta-blockers and/or calcium channel blockers.

What is the effect of Ivabradine in treating heart failure?

Background: Heart rate reduction has been studied as a therapeutic target in adults with heart failure (HF). Ivabradine has shown promising efficacy but has not yet been evaluated in children. Currently, treatment recommendations for chronic pediatric heart failure are primarily based on adult chronic heart failure guidelines.

Objective: To explore the dose-response relationship of ivabradine in children with dilated cardiomyopathy and symptomatic chronic heart failure. The primary endpoint was a ≥20% decrease in heart rate from baseline without induction of bradycardia or symptoms.

Methods: This was a randomized, double-blind, placebo-controlled phase II/III study with 12-month follow-up. Children receiving treatment for stable heart failure were randomized to receive ivabradine or placebo. After the initial titration period, doses were adjusted to achieve the primary endpoint. Left ventricular function (echocardiography), clinical status (New York Heart Association functional class or Ross class), N-terminal B-type natriuretic peptide precursor, and quality of life (QOL) were assessed.

Results: Across doses, 51 of 73 children taking ivabradine met the primary endpoint, compared with 5 of 41 children taking placebo. Between baseline and 12 months, patients taking ivabradine had a greater increase in left ventricular ejection fraction than those taking placebo.

At 12 months, the New York Heart Association functional class, or Ross class, improved more in the ivabradine group than in the placebo group. Ivabradine showed a trend toward improved QOL compared with placebo. The decrease in N-terminal B-type natriuretic peptide precursor levels was similar in both groups.

Conclusion: Ivabradine safely reduces resting heart rate in children with chronic heart failure and dilated cardiomyopathy. The effects of ivabradine on heart rate are variable, highlighting the importance of dose titration.

Ivabradine treatment improved left ventricular ejection fraction, and clinical status and QOL showed favorable trends.

What is the usage and dosage of Ivabradine?

1. Adult patients: The recommended starting dose is 5mg, twice a day, taken with food. Evaluate after two weeks and adjust dose to a maximum dose of 7.5 mg twice daily.

2. Adult patients who are unable to swallow tablets: For adult patients who have difficulty swallowing, they can take oral liquid and start treatment at a dose of 2.5 mg twice a day as directed by the doctor.

3. Pediatric patients 6 months and above and weighing less than 40 kg: It is recommended to take the oral solution twice a day with meals, with a starting dose of 0.05 mg/kg.

4. Patients 6 months to under 1 year old: The maximum dose is 0.2mg/kg, twice a day.

5. Patients 1 year old and above: The maximum dose is 0.3mg/kg, twice a day, and the maximum total dose is 7.5mg.

6. Pediatric patients weighing 40 kg and above: The recommended starting dose is 2.5 mg tablets, twice a day.

7. Reduce the dose for bradycardia: For patients with bradycardia, consider reducing the dose to 0.02 mg/kg.

What are the contraindications of Ivabradine?

Although the therapeutic effect of Ivabradine is relatively good, it is not suitable for certain people. Ivabradine is contraindicated in the following patients:

Acute decompensated heart failure;

Clinically significant hypotension;

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Sick sinus syndrome, sinus block, or third-degree atrioventricular block;

Clinically significant bradycardia;

Severe liver damage;

Pacemaker dependence (heart rate maintained only by a pacemaker);

Concomitant use of strong cytochrome P450s Patients with 3A4 (CYP3A4) inhibitors.

Summary

Ivabradine is a type of drug that reduces sinus rhythm. During treatment, patients should strictly follow the doctor's instructions and go to the hospital for regular review to check changes in heart function, heart structure and other aspects, and adjust drugs and treatment plans in a timely manner.

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