Currently available antiarrhythmic agents for the treatment of atrial fibrillation have important limitations, leaving an unmet need for safe and effective therapy.
Ranolazine is an approved antianginal agent with a favorable safety profile and electrophysiological properties suggesting a potential role in the treatment of atrial fibrillation.
The objective of a study ( RAFFAELLO [ Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion ] ) was to assess the safety and efficacy of Ranolazine in the prevention of atrial fibrillation recurrence after successful electrical cardioversion, and to attempt to ascertain the most appropriate dose of this agent.
This prospective, multicenter, randomized, double-blind, placebo-control parallel group phase II dose-ranging trial randomized patients with persistent atrial fibrillation ( 7 days-6 months ) 2 hours after successful electrical cardioversion to placebo, Ranolazine 375, 500 or 750 mg bid.
The primary endpoint was the time to first atrial fibrillation recurrence.
Of 241 patients randomized 238 took at least 1 drug dose. Ranolazine proved to be safe and tolerable.
No dose of the drug significantly prolonged time to atrial fibrillation recurrence. Atrial fibrillation recurred in 56.4%, 56.9%, 41.7% and 39.7% of the placebo, Ranolazine 375 mg, Ranolazine 500 mg and Ranolazine 750 mg patients, respectively.
The reduction in overall atrial fibrillation recurrence in the combined 500 and 750 mg groups was of borderline significance when compared to the placebo group ( p=0.053 ) and significant when compared to 375-mg group ( p=0.035 ).
In conclusion, no dose of Ranolazine significantly prolonged time to atrial fibrillation recurrence. However, the 500 and 750 mg groups combined reduced atrial fibrillation recurrences, suggesting a possible role for this agent in the treatment of atrial fibrillation. ( Xagena )
De Ferrari GM et al, Heart Rhythm 2015; Epub ahead of print