Brinavess Superior to Ibutilide in Conversion to Sinus Rhythm

In October 2010,Vernakalant was placed on clinical hold by the FDA during a Phase 3 trial
In October 2010,Vernakalant was placed on clinical hold by the FDA during a Phase 3 trial

Conversion to sinus rhythm (SR) in patients with recent-onset atrial fibrillation (AF) (<48 hours duration) was significantly shorter with Brinavess (vernakalant; Cardiome Pharma) than ibutilide, according to the findings of an open label, single-center, randomized controlled study. The full findings of the study were published online in the journal Europace.

Researchers compared the conversion time to SR between a Brinavess treatment group (n=49) and an ibutilide treatment group (n=51) within 90 minutes in recent-onset AF patients.

Result showed that the Brinavess group had a median conversion time of AF to SR of 10 minutes (interquartile range [IQR] 6–17), compared to the ibutilide group, who had a median time of 26 minutes (IQR 9–55). Furthermore, the Brinavess group displayed a significantly higher conversion success within 90 minutes than the ibutilide group, 69% vs. 43% (P=0.002), respectively.

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Conversion to SR after the initial infusions was also greater in the Brinavess group; 59% vs. 27%, respectively. Ninety-two percent of those who failed to cardiovert with Brinavess and subsequently had to have electrical cardioversion, were successfully cardioverted after 1 shock. In the ibutilide group, only 65% converted after 1 shock.

Vernakalant was placed on clinical hold by the FDA during the Phase 3 ACT V trial in October 2010. Cardiome Pharma plans to work with the FDA to lift the hold and resume clinical development for the U.S. market.

For more information call (604) 677-6905 or visit europace.oxfordjournals.org.

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