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RAPIBLOC (landiolol), cardioselective beta blocker

CARDIOLOGY - New medicinal product
Opinions on drugs - Posted on Feb 22 2019

Reason for request

Inclusion

High clinical benefit in the treatment of supraventricular tachycardia in patients presenting with atrial fibrillation or flutter and non-compensatory sinus tachycardia, but no demonstrated clinical advantage in the therapeutic strategy

 

  • RAPIBLOC has been granted a marketing authorisation for the treatment of supraventricular tachycardia in patients presenting with atrial fibrillation or flutter and non-compensatory sinus tachycardia, if the physician considers that the increased heart rate needs to be treated during the peri- and postoperative periods.

  • Its efficacy has been demonstrated on substitution criteria (heart rate control), conducted on a Japanese population and extrapolated to Caucasian patients based on pharmacokinetic (PK) and pharmacodynamic (PD) studies. No clinical studies have been conducted to assess the efficacy and safety of RAPIBLOC in this patient population.

  • No comparative data are available to document the efficacy of landiolol relative to other available injectable beta blockers.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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