De Ferrari, Gaetano M. and Maier, Lars S. and Mont, Lluis and Schwartz, Peter J. and Simonis, Gregor and Leschke, Matthias and Gronda, Edoardo and Boriani, Giuseppe and Darius, Harald and Guillamon Toran, Laura and Savelieva, Irene and Dusi, Veronica and Marchionni, Niccolo and Quintana Rendon, Miguel and Schumacher, Kai and Tonini, Giulia and Melani, Lorenzo and Giannelli, Stefano and Maggi, Carlo Alberto and Camm, A. John (2015) Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study. HEART RHYTHM, 12 (5). pp. 872-878. ISSN 1547-5271, 1556-3871
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND Currently available antiarrhythmic agents for the treatment of atrial fibrillation (AF) have important limitations, leaving an unmet need for safe and effective therapy. Ranolazine is an approved antianginal agent with a favorable safety profile and electrophysiologic properties suggesting a potential role in the treatment of AF. OBJECTIVE The purpose of this study was to assess the safety and efficacy of ranolazine in the prevention of AF recurrence after successful electrical cardioversion and to ascertain the most appropriate dose of this agent. METHODS This prospective, multicenter, randomized, double-blind, placebo-control parallel group phase II dose-ranging trial randomized patients with persistent AF (7 days to 6 months) 2 hours after successful electrical cardioversion to placebo, or ranolazine 375 mg, 500 mg, or 750 mg bid. Patients were monitored daily by transtelephonic ECG. The primary end-point was the time to first AF recurrence. RESULTS 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 AF recurrence. AF recurred in 56.4%, 56.9%, 41.7%, and 39.7% of patients in the placebo, ranoLazine 375 mg, ranoLazine 500 mg, and ranolazine 750 mg groups, respectively. The reduction in overall AF recurrence in the combined 500-mg and 750-mg groups was of borderline significance compared to the placebo group (P = .053) and significant compared to 375-mg group (P = .035). CONCLUSION No dose of ranolazine significantly prolonged time to AF recurrence. However, the 500-mg and 750 mg-groups combined reduced AF recurrences, suggesting a possible role for this agent in the treatment of AF.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DRONEDARONE; MANAGEMENT; ARRHYTHMIAS; COMBINATION; AMIODARONE; RHYTHM; PREVENTION; PROTECTION; GUIDELINES; OUTCOMES; Antiarrhythmic drug; Atrial fibrillation; Atrial flutter; Ranolazine; Electrophysiology; Cardioversion; controlled trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Jul 2019 07:07 |
| Last Modified: | 22 Jul 2019 07:07 |
| URI: | https://pred.uni-regensburg.de/id/eprint/5596 |
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