Cardiome and Astellas see positive results from ACT 2 trial

The so-called ACT 2 trial evaluated the efficacy and safety of the intravenous formulation of vernakalant hydrochloride (vernakalant (iv)) for the treatment of patients who developed atrial fibrillation or atrial flutter between 24 hours and seven days after coronary artery bypass graft or valve replacement surgery.

According to the companies, the trial reached it primary endpoint in the combined atrial fibrillation and atrial flutter groups, showing that 45% of patients receiving vernakalant (iv) converted to normal heart rhythm within 90 minutes, as compared to 15% of placebo patients within the same time period.

In the patients treated with vernakalant (iv) who converted to normal heart rhythm within 90 minutes, the median time to conversion was 12 minutes from the initiation of dosing.

However, although 47% of the atrial fibrillation patients dosed with the treatment experienced conversion to normal heart rhythm within 90 minutes, as compared to 14% of placebo patients; of the 10 patients in the atrial flutter population, no patients in the drug group and one patient in the placebo group converted to normal heart rhythm.

Nevertheless, Cardiome and Astellas said that the ACT 2 study data suggests that vernakalant (iv) was well-tolerated in the studied patient population. Potentially drug-related serious adverse events occurred in 2% of patients who received the treatment and 0% of placebo patients.

“We are delighted to see a 47% conversion rate in post-operative atrial fibrillation patients, and in particular we are encouraged by the safety profile observed in this fragile patient population,” stated Bob Rieder, CEO and chairman of Cardiome.