Cardiome Pharma Reports Results of Independent Study of Intravenous Vernakalant in Patients with Cardioversion Resistant Atrial Fibrillation

Cardiome Pharma Corp. (TSX:COM,NASDAQ:CRME) announced that an independent study conducted at the University of Leipzig Heart Center in Germany, found that intravenous vernakalant facilitated successful electrical cardioversion in patients who had failed to attain sinus rhythm (SR) following failed electrical cardioversion, or who immediately returned to Atrial Fibrillation after briefly attaining SR.

As quoted in the press release:

The study, entitled “Vernakalant-facilitated electrical cardioversion: comparison of intravenous vernakalant and amiodarone for drug-enhanced electrical cardioversion of atrial fibrillation after failed electrical cardioversion” authored by Andreas Müssigbrodt et al., is published in the Advanced Access section of journal Europace website (June 8, 2015). Cardiome Pharma Corp. did not fund the study, design its protocols or have any role in study implementation or analysis.

The non-randomized study examined if either of two pharmacologic converting agents, vernakalant or amiodarone, facilitated subsequent ECV in 63 patients with IRAF (n = 44; 70%) or FECV (n = 19; 30%) after consecutive ECV. Patients were assigned to receive either a single dose of vernakalant (n = 33; 52%) or amiodarone (n = 30; 48%) prior to another attempt with ECV at the discretion of the treating physician. Ten minutes after completion of the drug infusion, transthoracic ECV was attempted again with a shock that had the same energy as the previous shock. In the event of another episode of IRAF, no more attempts of ECV were repeated.

The study found that 66.7% of the patients in the vernakalant group (22 of 33 patients) were successfully electrically cardioverted after drug infusion compared to 46.7% (14 of 30 patients) of patients treated with amiodarone (P=0.109). Treatment with vernakalant was also listed as a predictor of successful, drug-facilitated ECV based upon the results of a multivariate analysis (OR 0.057, 95% CI 0.006-0.540, P=0.013).

Dr. Steen Juul-Möller, medical director of Cardiome Pharma, commented:

We are very excited to see the results from this small non-randomized study in a resistant patient population but larger, controlled clinical studies will be necessary to confirm its findings. These results underline the vernakalant -induced stabilizing effect on the atrial wavelets in Atrial Fibrillation, facilitating cardioversion even in patients with AF relapse after lung vein isolation ablation.” In addition, Dr. Juul-Möller commented that “Taken together with the independent data published earlier this year suggesting that challenging post-surgical patients also received a benefit from vernakalant, this new data within resistant patients suggests that physicians who are using vernakalant in their clinical practice show continued high interest to explore its use by expanding scientific evidence.

Click here to read the full Cardiome Pharma Corp. (TSX:COM,NASDAQ:CRME) press release.