BRINAVESS (vernakalant), class I and III antiarrhythmic

CARDIOLOGY - New medicinal product

Opinions on drugs - Posted on Jun 03 2015

Inclusion

BRINAVESS has Marketing Authorisation as a treatment for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult non-surgery patients (AF < 7 days duration) or post‑cardiac surgery patients: AF < 3 days duration).
The demonstration of efficacy is based on a very short-term intermediate criterion. No effect on cardiovascular morbidity or mortality has been demonstrated.
The available data are based on a single comparative study versus placebo or amiodarone used at suboptimal doses compared with the dosages of the Marketing Authorisation and under conditions that do not permit objective evaluation of its efficacy.
Treatment strategies involving vernakalant in the management of high-risk patients are complex, given its contraindications (in combination with class I and III intravenous antiarrhythmics) and the difficulties using it in the event of haemodynamically stable heart failure, even if it is in functional class I, since the target population is largely elderly.

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