Monitor patients taking ivabradine for bradycardia, EMA recommends

In light of preliminary data from the SIGNIFY study, the European Medicines Agency has reviewed the benefits and risks associated with ivabradine (Procoralan).

Procoralan (ivabradine) is currently licensed in the treatment of chronic stable angina and in heart failure.
Procoralan (ivabradine) is currently licensed in the treatment of chronic stable angina and in heart failure.

Ivabradine is indicated in patients with normal heart rhythm for the treatment of chronic stable angina in coronary artery disease, and for the treatment of stable chronic heart failure.

The placebo-controlled SIGNIFY study tested the efficacy of ivabradine in patients with coronary artery disease without clinical heart failure. The dose used was higher than that licensed for the existing indications (7.5–10mg twice daily vs 5–7.5mg twice daily).

Results showed that the sinus node Iinhibitor was associated with a small but significant increase in the combined risk of cardiovascular death and non-fatal myocardial infarction in patients with symptomatic angina of CCS class II—IV. This risk may be associated with a target heart rate below 60bpm.

Advice

Healthcare professionals are recommended to:

  • carefully monitor patients for bradycardia and its symptoms (eg, dizziness, fatigue, hypotension);
  • avoid concomitant use of ivabradine with any calcium channel blocker that reduces heart rate, such as verapamil or diltiazem;
  • review patients currently taking ivabradine where appropriate.

Dosing

The initial dose of ivabradine is 5mg twice daily with meals. If necessary, this can be increased to 7.5mg twice daily after 2 weeks (in heart failure) or 3–4 weeks (in angina) if treatment with 5mg is well-tolerated but an inadequate response is achieved. The dose may be reduced to 2.5mg twice daily if not tolerated.

In addition, the dose should be down-titrated if the resting heart rate decreases persistently below 50bpm or the patient experiences symptoms of bradycardia. If symptoms persist, prescribers should consider discontinuing treatment.

View Procoralan drug record

Further information: Servier

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