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ivabradine (Procoralan)

Advice

following a full submission:

ivabradine (Procoralan®) is accepted for restricted use within NHS Scotland.

Indication under review: Chronic heart failure New York Heart Association (NYHA) II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 beats per minute (bpm), in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contra-indicated or not tolerated.

SMC restriction: for initiation only in patients whose resting heart rate remains ≥75 beats per minute despite optimal standard therapy. 

In a post-hoc subgroup analysis of the pivotal study in patients meeting the licensed indication, ivabradine was significantly more effective than placebo at reducing the risk of a composite of cardiovascular death or hospitalisation for worsening heart failure.  However, in patients on the target dose of beta-blocker, ivabradine was not significantly more effective.
 

Drug Details

Drug Name: ivabradine (Procoralan)
SMC Drug ID: 805/12
Manufacturer: Servier Laboratories Ltd
Indication: Chronic heart failure New York Heart Association (NYHA) II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥75 beats per minute (bpm), in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contra-indicated or not tolerated.
BNF Category:
Sub Category: 2.6 Nitrates calcium-channel blockers and other antianginal drugs
Submission Type: Full submission
Status: Restricted
Date Advice Published: 8 October 2012

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