Propafenone efficacy and safety in restoring and maintaining sinus rhythm in patients with recurrent atrial fibrillation: results of the open, prospective placebo-controlled trial
Abstract
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.
About the Authors
I. G. Fomina
I.M. Sechenov Moscow Medical Academy, City Clinical Hospital No. 61, Moscow
Russian Federation
Russian Federation
A. V. Vetlyzhsky
I.M. Sechenov Moscow Medical Academy, City Clinical Hospital No. 61, Moscow
Russian Federation
Russian Federation
A. I. Tarzimanova
I.M. Sechenov Moscow Medical Academy, City Clinical Hospital No. 61, Moscow
Russian Federation
Russian Federation
A. A. Abramova
I.M. Sechenov Moscow Medical Academy, City Clinical Hospital No. 61, Moscow
Russian Federation
Russian Federation
References
1. Хамицаева Е.О., Шевченко Н.М., Богданова Е.Я., Джанашия П.Х. Сравнительная эффективность однократного приема внутрь амиодарона и пропафенона в купировании пароксизмального мерцания предсердий. РКЖ 2003; 2: 49-53.
2. Захар А., Антонченко И., Борисова Е.В., Попов С.В. Восстановление синусового ритма пропафеноном и амиодароном у пациентов с фибрилляцией предсердий. Кардиоваск тер профил 2004; 3(4, приложение 2): 176.
3. Киселева Г.И., Крюков Н.Н., Германова И.К., Фурманчук Н.И. Сравнительная оценка эффективности применения пропафенона и амиодарона у больных с фибрилляцией предсердий. Кардиоваск тер профил 2004; 3(4, приложение 2): 223;
4. Van Gelder IC, Hagens VE, Bosker HA, et al. A comparsion of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med 2002; 347: 1834-40.
5. Wyse DG, Waldo AL, DiMarco JP, et al. A comparison of rate and rhythm control in patients with recurrent persistent atrial fibrillation. The Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Investigators. N Engl J Med 2002; 347: 1825-33.
6. Vaughan Williams EM. A classification of antiarrhythmic actions reassessed after a decade of new drugs. J Clin Pharmacol 1984; 24: 129-47.
7. Deneer VH, Borgh MB, Kingma JH, et al. Oral antiarrhythmic drugs in converting recent onset atrial fibrillation. Pharm World Sci 2004; 26(2): 66-78.
8. Khan IA. Single oral loading dose of propafenone for pharmacological cardioversion of recent-onset atrial fibrillation. JACC 2001; 37(2): 542-7.
9. Antonelli D, Darawsha A, Rimbrot S, et al. Propafenone dose for emergency room conversion of paroxysmal atrial fibrillation. Harefuah. 1999;136(11): 857-9, 915.
10. Dogan A, Ergene O, Nazli C, et al. Efficacy of propafenone for maintaining sinus rhythm in patients with recent onset or persistent atrial fibrillation after conversion: a randomized, placebocontrolled study. Acta Cardiol 2004; 59(3): 255-61.
11. Kochiadakis GE, Igoumenidis NE, Hamilos MI, et al. Longterm maintenance of normal sinus rhythm in patients with current symptomatic atrial fibrillation: amiodarone vs propafenone, both in low doses. Chest 2004;125(2): 377-83.
12. Fuster V, Ryden LE, Asinger RW, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). JACC 2001; 38: 1266-90.
13. Boriani G, Capucci A, Lenzi T, et al. Propafenone for conversion of recent-onset atrial fibrillation: a controlled comparison between oral loading dose and intravenous administration. Chest 1995; 108: 355- 8.
Review
For citations:
Fomina I.G., Vetlyzhsky A.V., Tarzimanova A.I., Abramova A.A. Propafenone efficacy and safety in restoring and maintaining sinus rhythm in patients with recurrent atrial fibrillation: results of the open, prospective placebo-controlled trial. Cardiovascular Therapy and Prevention. 2005;4(2):67-73. (In Russ.)
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