Propafenone efficacy and safety in restoring and maintaining sinus rhythm in patients with recurrent atrial fibrillation: results of the open, prospective placebo-controlled trial

Aim. To study efficacy and safety of propafenone in restoring and maintaining sinus rhythm (SR), comparing to placebo, in patients with recurrent atrial fibrillation (AF). Material and methods. The study included 60 patients with recurrent AF. For restoring SR, all patients were administered propafe...

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Main Authors: I. G. Fomina, A. V. Vetlyzhsky, A. I. Tarzimanova, A. A. Abramova
Format: Article
Language:Russian
Published: «SILICEA-POLIGRAF» LLC 2005-04-01
Series:Кардиоваскулярная терапия и профилактика
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Online Access:https://cardiovascular.elpub.ru/jour/article/view/933
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Summary:Aim. To study efficacy and safety of propafenone in restoring and maintaining sinus rhythm (SR), comparing to placebo, in patients with recurrent atrial fibrillation (AF). Material and methods. The study included 60 patients with recurrent AF. For restoring SR, all patients were administered propafenone (300-600 mg/d). Twenty-four hours later, all participants with normalized SR were randomized into two groups: Group I (n=31) received propafenone (450 mg/d), Group 2 (n=15) – placebo. Follow-up lasted for 3 months. Results. Twenty-four hours after propafenone administration (300-600 mg), SR was registered in 46 individuals (76.6%), including 2 patients (3%) with SR normalization 2 hours later, 5 patients (10.9%) – 4 hours later, 23 (50%) – 6 hours later, and 16 (34.8%) – 8 hours later. Mean time to SR normalization was 364±22 minutes. Adverse effects included moderate hypotension to 105-100/70 mm Hg in 2 patients (3.3%), and transitory atrioventricular block II in 1 patient (1.7%). No other adverse reactions were registered. During 3-month propafenone treatment (450 mg/d), SR was maintained in 80.6% of patients, compared to 26.6% in placebo group. No adverse reactions were observed. Conclusion. Oral propafenone treatment is effective and safe for restoring and maintaining SR in patients with recurrent AF.
ISSN:1728-8800
2619-0125