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EU approval for Vernakalant infusion for Rapid Conversion of Recent Onset AF

The intravenous (IV) formulation of ‘Brinavess’™ (Vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

The full indication is for the rapid conversion of recent onset AF to sinus rhythm in adults: for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.

Vernakalant, which has been developed as a collaboration between MSD and Cardiome Pharma Corp, is reported to be the first agent that acts preferentially in the atria . The approval of vernakalant is based on the results of three randomized, double-blind, placebo-controlled studies (ACT I, ACT II, and ACT III) and an active comparator trial (AVRO).

In ACT I and III, the efficacy of vernakalant at converting patients from AF to sinus rhythm for a minimum duration of one minute within 90 minutes of initiating therapy was evaluated in 390 haemodynamically stable adult patients with short duration AF (3 hours to 7 days) versus placebo.  In ACT I, vernakalant cardioverted 51.0 percent of patients versus 4.0 percent of patients taking placebo (n=74 and 3, respectively; p<0.0001).  In ACT III, vernakalant cardioverted 51.2 percent of patients versus 3.6 percentof patients taking placebo (n=44 and 3, respectively; p <0.0001).

Conversion of AF to sinus rhythm occurred rapidly; in responders, the median time to conversion was 10 minutes from start of first infusion based on pooled results from the ACT I and ACT III studies.

The efficacy of vernakalant also was studied in ACT II in 150 patients with sustained AF (3 hours to 72 hours duration) that occurred between 24 hours and 7 days post coronary artery bypass graft and/or valvular surgery.  Treatment with vernakalant effectively converted 47.0 percent of patients from AF to sinus rhythm versus 14.0 percent with placebo (p=0.0001).

In the AVRO study, vernakalant was significantly more effective than amiodarone IV in providing rapid conversion to sinus rhythm within 90 minutes of initiating therapy.

In the AVRO (Active-Controlled, Multi-Center Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation) study, vernakalant was demonstrated to be significantly faster than amiodarone IV in restoring AF patients to sinus rhythm.  In the trial, vernakalant was studied in 116 patients with AF (3 hours to 48 hours) versus 116 patients on amiodarone. The amiodarone infusion was given over two hours (i.e., one hour loading dose of 5 mg/kg, followed by one hour maintenance infusion of 50 mg) with the objective to compare rapid conversion to sinus rhythm.  The primary endpoint was the proportion of patients that achieved sinus rhythm for a minimum duration of one minute within 90 minutes of first exposure of the study drug.

In this study, treatment with vernakalant converted 51.7 percent of patients to sinus rhythm at 90 minutes versus 5.2 percent with amiodarone.

Vernakalant is contraindicated in patients with prolonged QT at baseline (uncorrected >440 msec), severe bradycardia, sinus node dysfunction, or second-degree or third-degree heart block in the absence of a pacemaker.

The drug is also contraindictated in patients who use intravenous rhythm control antiarrhythmics (class I and class III) within four hours prior to administration of Vernakalant and patients with acute coronary syndrome (including myocardial infarction) within the last 30 days. For further details of Vernakalant and prescribing information please refer to the manufacturers Summary of Product Characteristics.

Published on: September 20, 2010

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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