Therapeutic efficacy and safety of oral propafenone for atrial fibrillation

doi:10.1016/0002-9149(89)91091-6

The American Journal of Cardiology

Volume 63, Issue 1, 1 January 1989, Pages 114-116

https://doi.org/10.1016/0002-9149(89)91091-6 Get rights and content

Abstract

Propafenone, a class 1C antiarrhythmic drug, was developed in Europe in 1970. After 7 years of clinical trials, it was marketed commercially there. The favorable European data have been corroborated in United States clinical trials, which began in 1980. Propafenone has been shown to be an effective agent for suppressing ventricular arrhythmias and preventing recurrence during long-term therapy.^1–3 It has been reported to be of use in patients with supraventricular tachycardia, especially in those with Wolff-Parkinson-White syndrome and atrioventricular nodal reentrant tachycardia.^4,5 It has been suggested that propafenone may have a role in paroxysmal atrial fibrillation (AF).^6,7 To date, data concerning the efficacy and safety of propafenone for patients experiencing chronic and sustained AF have not been examined. We report our clinical experience of the long-term therapeutic efficacy and safety of propafenone in converting AF and maintaining normal sinus rhythm in such a patient population.

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Cited by (50)

2011 ACCF/AHA/HRS Focused Updates Incorporated Into the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society
2011, Journal of the American College of Cardiology
Citation Excerpt :
The pattern of AF (paroxysmal or persistent), LA size, and previous response to drug therapy did not predict efficacy, but statistical power for this secondary analysis was limited. Other uncontrolled studies, usually involving selected patients refractory to other antiarrhythmic drugs, also support the efficacy of propafenone (605–609). In a randomized study, propafenone and disopyramide appeared equally effective in preventing postcardioversion AF, but propafenone was better tolerated (589).
Sotalol versus propafenone for long-term maintenance of normal sinus rhythm in patients with recurrent symptomatic atrial fibrillation
2004, American Journal of Cardiology
Long-term Maintenance of Normal Sinus Rhythm in Patients with Current Symptomatic Atrial Fibrillation: Amiodarone vs Propafenone, Both in Low Doses
2004, Chest
Citation Excerpt :
As regards propafenone, our study showed that it is relatively safe. However, the low doses of propafenone and the fact that patients with severe heart disease or low cardiac output were excluded must be taken into account, since it is well known that the side effects of propafenone are dose dependent and tend to be higher in patients with underlying structural heart disease.234512131415161718192021 To our knowledge there is only one other study21 that has also compared these drugs; the authors claim that amiodarone is clearly superior to propafenone in maintaining sinus rhythm.
To compare the efficacy and safety of amiodarone and propafenone when used for the prevention of atrial fibrillation (AF) and maintenance of normal sinus rhythm in patients with refractory AF.
Prospective, randomized, single-blind trial.
Tertiary cardiac referral center.
One hundred forty-six consecutive patients (72 men; mean age, 63 ± 10 years [± SD]) with recurrent symptomatic AF.
We studied 146 patients after restoration of sinus rhythm; patients were randomized to amiodarone, 200 mg/d, or propafenone, 450 mg/d. Follow-up clinical evaluations were conducted at the first, second, fourth, and sixth months, and at 3-month intervals thereafter. The proportion of patients relapsing to AF and/or experiencing side effects was calculated for each group using the Kaplan-Meier method. End point of the study was recurrence of AF or occurrence of side effects necessitating discontinuation of medication.
Of 146 patients, 72 received amiodarone and 74 received propafenone. The two groups were clinically similar. Of the 72 patients receiving amiodarone, AF developed in 25 patients, after an average of 9.8 months, compared to 33 of the 74 patients receiving propafenone after an average of 3.8 months. Twelve patients receiving amiodarone and 2 patients receiving propafenone had side effects necessitating withdrawal of medication while still in sinus rhythm.
Amiodarone tends to be more effective than propafenone in maintaining sinus rhythm in patients with AF, but this advantage is offset by a higher incidence of side effects.
Pharmacologic conversion of atrial fibrillation: A systematic review of available evidence
2001, Progress in Cardiovascular Diseases
This report reviews the efficacy of currently available antiarrhythmic agents for conversion of atrial fibrilation (AF) to normal sinus rhythm (NSR). A systematic search of literature in the English language was done on computerized databases, such as MEDLINE, EMBASE, and Current Contents, in reference lists, by manual searching, and in contact with expert informants. Published studies involving humans that described the use of antiarrhythmic therapy for conversion of AF to NSR were considered and only studies that examined the use of agents currently available in the United States were included. Studies exclusively describing antiarrhythmic therapy for conversion of postsurgical AF were excluded. The methodology and results of each trial were assessed and attempts were made to acquire additional information from investigators when needed. Assessment of methodological quality was incorporated into a levels-of-evidence scheme. Eighty-eight trials were included, of which 34 (39%) included a placebo group (level I data). We found in recent-onset AF of less than 7 days, intravenous (IV) procainamide, high-dose IV or high-dose combination IV and oral amiodarone, oral quinidine, oral flecainide, oral propafenone, and high-dose oral amiodarone are more effective than placebo for converting AF to NSR. In recent-onset AF of less than 90 days, IV ibutilide is more effective than placebo and IV procainamide. In chronic AF, oral dofetilide converts AF to NSR within 72 hours, and oral propafenone and amiodarone are effective after 30 days of therapy. We conclude than for conversion of recent-onset AF of less than 7 days, procainamide may be considered a preferred IV agent and propafenone a preferred oral agent. For conversion of recent-onset AF of longer duration (less than 90 days), IV ibutilide may be considered a preferred agent. For patients with chronic AF and left ventricular dysfunction, direct current cardioversion is the preferred conversion method. Larger, well-designed randomized controlled trials with clinically important endpoints in specific populations of AF patients are needed. Copyright © 2001 by W.B. Saunders Company
Progress in Cardiovascular Diseases, Vol. 44, No. 2, (September/October) 2001: pp 121-152
Propafenone for the Treatment of Supraventricular Tachycardia and Atrial Fibrillation: A Meta-Analysis
1998, American Journal of Cardiology
The purpose of this study was to determine propafenone’s effectiveness in terminating and suppressing supraventricular arrhythmias using meta-analytic techniques. Published abstracts and manuscripts with these goals were selected and data abstracted on conversion and maintenance of sinus rhythm. Data were pooled using standard meta-analytic techniques and analyzed according to observation times, trial design (randomized versus nonrandomized), and route of drug administration. Propafenone successfully terminated 83.8% (95% confidence interval 78.1–89.7%) of supraventricular tachycardias. For supraventricular tachycardias, the proportion of patients remaining in sinus rhythm without recurrent arrhythmia was 64.6% (58.1–71.1%) at 1 year. The likelihood of converting a paroxysm of atrial fibrillation (AF) increased over time, with 76.1% (72.8–79.4%) of patients in sinus rhythm 24 hours after initiation of therapy. Patients receiving intravenous therapy were more likely to convert to sinus rhythm in the first 4 hours after drug administration. The treatment benefit of propafenone versus placebo in converting sinus rhythm was greatest in the first 8 hours after treatment (treatment benefit of 31.5% [24.5–38.5%] at 4 hours and 32.9% [24.3–41.5%] at 8 hours, p <0.01). This treatment benefit decreased to 11.0% (−0.6–22.4%) after 24 hours. Propafenone was effective in suppressing recurrences of AF in 55.4% (51.3–59.7%) at 6 months and 56.8% (52.3–61.3%) at 12 months. Thus, propafenone is effective in terminating supraventricular tachycardias and AF in the vast majority of patients. Suppression of arrhythmia recurrences is feasible in most patients, although its effectiveness decreases over time.
Low-dose amiodarone versus sotalol for suppression of recurrent symptomatic atrial fibrillation
1998, American Journal of Cardiology
To compare the safety and efficacy of amiodarone and sotalol in the treatment of patients with recurrent symptomatic atrial fibrillation (AF), 70 patients were entered into a randomized, double-blind study. Of these, 35 received amiodarone and 35 sotalol. There were no significant differences in baseline clinical characteristics between groups. Patients with ejection fraction <40% or clinically significant heart disease were excluded. Patients randomized to amiodarone began with 800 to 1,600 mg/day for 7 to 14 days orally. After the initial loading phase, the drug dose was tapered to maintenance levels over 7 to 12 days; thereafter, therapy was generally maintained at a dosage of 200 mg/day. The sotalol dosage was 80 to 360 mg twice daily, as tolerated. Follow-up clinical evaluations were conducted at 1, 2, 4, 6, 9, and 12 months. The proportion of patients remaining in sinus rhythm on each agent was calculated for the 2 groups using the Kaplan-Meier method. Ten of the 35 patients who were taking amiodarone developed AF during the 12-month observation period, compared with 21 of the 35 who were taking sotalol (p = 0.008). No significant effect of sex, age, left atrial size, or type of AF could be detected that increased the risk of development of AF. We conclude that both amiodarone and sotalol can be used for the maintenance of normal sinus rhythm in patients with recurrent symptomatic AF but that amiodarone is the more effective of the 2 drugs for this purpose.

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Brief reportTherapeutic efficacy and safety of oral propafenone for atrial fibrillation

Abstract

Am J Cardiol

JACC

Am Heart J

JACC

Brief report
Therapeutic efficacy and safety of oral propafenone for atrial fibrillation