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PROCORALAN (ivabradine), selective If channel inhibitor

CARDIOLOGY - Focus
Opinions on drugs - Posted on Sep 15 2015

Reason for request

Re-assessment of the actual benefit and of the improvement in actual benefit

Does not recommend the continuation of reimbursement in the symptomatic treatment of chronic stable angina

  • PROCORALAN has Marketing Authorisation in the symptomatic treatment of chronic stable angina in adults with coronary artery disease with normal sinus rhythm and heart rate greater than or equal to 70 bpm. Ivabradine is indicated:

-        in adults unable to tolerate or with a contraindication to the use of beta-blockers,
-        or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose (non-reimbursable indication).

  • In this indication, the efficacy of ivabradine has only been demonstrated on the basis of pharmacodynamic or symptomatic criteria, particularly the maintenance of the reduction in heart rate and the ergometric parameters; it has not been shown to have benefits in relation to the clinical criteria of morbidity and mortality.
  • An increase in the risk of the occurrence of cardiovascular events (composite endpoint combining cardiovascular mortality and non-fatal myocardial infarction) relative to placebo has been demonstrated in a subgroup of patients with class II to IV angina.
  • According to the available data, there is also an important risk of bradycardia and atrial fibrillation with ivabradine.

Clinical Benefit

Insufficient

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Therapeutic use

-

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