RAPIBLOC (landiolol), cardioselective beta blocker
Reason for request
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 Added Value
|no clinical added value||