Abstract
Synopsis
Propafenone is an orally active sodium channel blocking agent with β-adrenoceptor antagonist and weak calcium antagonist activity. The pharmacokinetic profile of propafenone is complex, characterised as typically nonlinear, saturable, stereoselective and dependent on both dose and debrisoquin metaboliser phenotype; individualised dosage titration is required.
Both placebo- and drug-controlled studies have confirmed the efficacy of propafenone in the treatment of premature ventricular complexes, ventricular couplets and nonsustained ventricular tachycardia; in a large meta-analysis, propafenone together with amiodarone, flecainide and encainide were significantly more effective in the control of ventricular ectopy than other antiarrhythmic agents. However, the use of propafenone in these indications, like that of other antiarrhythmic agents, is likely to be limited to patients with a favourable risk-to-benefit ratio. Propafenone has also demonstrated efficacy in the treatment of malignant ventricular arrhythmias (ventricular fibrillation and sustained ventricular tachycardia); preliminary mortality data obtained with propafenone have been encouraging in this patient group. In addition, propafenone has a favourable noncardiac tolerability profile and β-adrenoceptor antagonist activity, which may offer advantages in some specific patient groups.
The area of research concerning propafenone which has shown the greatest expansion over the past 5 years is in the treatment of supraventricular arrhythmias. Propafenone has marked efficacy in patients with Wolff-Parkinson- White syndrome and has been recommended as a first-line prophylactic agent in those with rapid anterograde conduction. Propafenone is also effective in the conversion of atrial fibrillation to sinus rhythm, although comparative studies are required to determine advantages over more established agents. Propafenone use has been successfully extended to children with limited data demonstrating consistent efficacy in the control of junctional ectopic tachycardia.
As with all antiarrhythmic agents, propafenone has the potential to induce arrhythmias. Comparative studies are required to assess in more detail the cardiac tolerability profile of propafenone against other class Ic agents.
In conclusion, propafenone offers a broad spectrum of activity in the treatment of cardiac arrhythmias, although its use in patients with potentially malignant arrhythmias will remain limited for the present. Due to its unique pharmacodynamic profile, propafenone deserves consideration as an individual agent.
Pharmacodynamic Properties
Data from animal experiments have shown that propafenone, and its major metabolites, block sodium channels in ventricular and Purkinje fibres, as assessed by a reduction in the maximum velocity of upstroke of phase 0 of the action potential. This blockade of sodium channels has been shown to be concentration- and use-dependent, and non-stereoselective. In addition, propafenone possesses properties of other classes of antiarrhythmic agents. Propafenone blocks β-adrenoceptors (class II activity) with a potency approximately one-fortieth that of propranolol in human volunteers, and this effect is stereoselective, with the S-enantiomer being the more potent. Electrophysiological characteristics of a class III agent has also been demonstrated in sinus node and myocardial tissue, although a reduction in action potential duration has been observed in Purkinje fibres. Propafenone also lengthens the effective refractory potential in atrial, ventricular and AV nodal tissue and Purkinje fibres, and has no effect on resting membrane potential and maximum diastolic potential in these tissues. Electrophysiological studies on isolated animal tissues have shown that propafenone has calcium and potassium channel blocking activity.
In healthy volunteers, propafenone increases PR and QRS intervals, and the 5-hydroxy metabolite has an additive effect on these parameters. In patients with a variety of arrhythmias propafenone causes a slowing of AV nodal, His-Purkinje, atrial and ventricular conduction, and increases ventricular and atrial refractoriness. Sinus cycle length is generally unaffected while sinus node recovery time is increased.
Propafenone is devoid of pronounced cardiodepressant activity, although a negative inotropic action in patients with impaired ventricular function (<50%) and reduction in systolic blood pressure has been observed. Heart rate may be decreased at doses within the therapeutic range. In patients with left ventricular dysfunction propafenone may produce a reduction in left ventricular ejection fraction.
The antiarrhythmic activity of propafenone has been demonstrated in isolated tissues and in several whole animal models, including aconitine-induced arrhythmias in the rat, arrhythmias associated with experimental myocardial infarction and re-entry atrial flutter. The major metabolite, 5-hydroxypropafenone, appears to be a more potent antiarrhythmic agent in these models than the parent compound.
Pharmacokinetic Profile
The pharmacokinetics of propafenone are predominantly nonlinear, saturable, stereoselective and dependent on dose and debrisoquin metaboliser phenotype. Propafenone is distributed rapidly and achieves high concentrations in the lung, liver and heart. The active 5-hydroxy metabolite is found in higher concentrations in heart tissue than in the plasma. Plasma protein binding is about 96% at therapeutic concentrations but decreases disproportionately at plasma drug concentrations above 1.5 mg/L. Free propafenone concentrations are 50% lower in patients with uraemia and correlate strongly with α1-acid glycoprotein levels. During pregnancy, propafenone crosses the placenta and is excreted into the breast milk.
Considerable first-pass metabolism occurs after oral doses, with Cmax values of the metabolites occurring in tandem with those of the parent drug; 5-hydroxypropafenone is often not detectable after intravenous administration. Propafenone may be subject to reduced metabolism with time. Elimination is primarily by hepatic oxidation and faecal excretion. Less than 1% of a dose is excreted unchanged. Cytochrome CYP2D6 oxidises propafenone to the 5-hydroxy metabolite and cytochromes CYP2A6/7 and CYP1A2 mediate N-dealkylation to the N-depropyl metabolite. About 7% of Caucasians are poor metabolisers of propafenone, forming little or no 5-hydroxy metabolite, but maintaining higher parent drug concentrations. Stereoselective differences in the metabolism of propafenone enantiomers have also been noted.
Concentration-dependent suppression of ventricular ectopy has been reported, but most studies enrolled too few patients to determine clear concentration-response relationships. Responders and nonresponders to the drug tended to display similar plasma drug concentrations.
Therapeutic Use
The efficacy of oral propafenone 300 to 900 mg/day in the treatment of malignant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation) has been confirmed in studies using both invasive and noninvasive monitoring techniques. Eight to 36% of patients demonstrated a complete response and 8 to 25% a partial response after 1 to 7 days’ treatment with propafenone in electrophysiological studies. Higher efficacy rates of 47 to 53% were observed after short term propafenone therapy in this patient group after noninvasive testing. The efficacy of propafenone was also maintained during long term follow-up in patients with malignant ventricular arrhythmias, with 40 to 91% of patients responding to treatment. Mortality data are available from a single ongoing study involving 186 survivors of sudden death. The rate of sudden death after a mean of 15 months’ treatment with propafenone 450 to 900 mg/day was 8.5% which was comparable or greater than that with metoprolol (10.6%), amiodarone (2.2%) and in patients implanted with an automatic cardioverter defibrillator (0%); total mortality rates were similar between treatment groups. Only one comparative trial, which demonstrated similar efficacy with intravenous propafenone 2.5 mg/kg and quinidine 10 mg/kg in patients with sustained ventricular arrhythmias, has been conducted to date.
The short term efficacy of oral propafenone in the treatment of potentially malignant ventricular arrhythmias (frequent or complex premature ventricular complexes, symptomatic or asymptomatic nonsustained ventricular tachycardia) has been demonstrated in a number of placebo-controlled studies; ⩾ 80% of premature ventricular complexes were suppressed in 54 to 80% of patients. Ventricular couplets and runs of nonsustained ventricular tachycardia appeared to be particularly susceptible to propafenone therapy. A dose-response relationship was observed with propafenone in the control of all 3 types of arrhythmia. In a 2-year study, there was significant attenuation in the number of responders to propafenone therapy, although treatment continued to be effective in the majority of patients (⩾ 79%).
Data from a large meta-analysis involving 95 studies suggested that the class Ic agents (propafenone, flecainide, encainide) and a class III agent (amiodarone), were significantly more effective than class Ia, Ib and II agents in the control of ventricular ectopy. Consistent with these results, smaller individual comparative studies have demonstrated that propafenone has equivalent efficacy to amiodarone, cibenzoline, diprafenone, pirmenol, quinidine and metoprolol and showed a trend towards better efficacy when compared with acebutolol and disopyramide.
Conversion to sinus rhythm in patients presenting with atrial fibrillation was achieved in 46 to 70% of patients receiving intravenous propafenone 1 to 2 mg/kg followed by drug infusion. A lower conversion rate of 33% was observed in patients with atrial flutter. The likelihood of conversion of atrial fibrillation to sinus rhythm with propafenone was inversely related to the duration of the arrhythmia. During longer term treatment, the efficacy of propafenone appeared to stabilise after 3 months’ therapy with complete or partial control of recurrent atrial fibrillation achieved in 38 to 67% of patients. In comparative studies, propafenone demonstrated comparable efficacy to amiodarone and quinidine in combination with digoxin and similar or lower efficacy than flecainide in the conversion of atrial fibrillation to sinus rhythm. The rate of conversion with propafenone was faster compared with amiodarone and quinidine + digoxin.
Oral propafenone was also effective in the suppression of paroxysmal supraventricular tachycardia and paroxysmal atrial fibrillation, although the long term efficacy (8 to 35 months) of propafenone appeared to be more variable.
Data from 2 small double-blind, placebo-controlled electrophysiological studies have confirmed the marked efficacy of intravenous propafenone in patients with Wolff-Parkinson-White syndrome exhibiting atrial fibrillation or atrioventricular re-entry tachycardia. Long term prophylactic use of oral propafenone successfully controlled supraventricular tachyarrhythmias in 38 to 100% of patients over a 7- to 36-month mean follow-up period. Two comparative studies in this patient group, demonstrated that propafenone had similar efficacy compared with ajmaline and a trend towards less efficacy compared with procainamide.
Although experience in patients with atrioventricular nodal re-entrant tachycardias remains extremely limited, intravenous propafenone 2 mg/kg successfully terminated arrhythmias in all 9 patients studied and drug efficacy was maintained over a 16-month follow-up period.
In children and infants, propafenone has demonstrated efficacy against a similar range of arrhythmias as in adult patients, with a long term efficacy rate of 40 to 76% in children. Propafenone also demonstrated consistent acute and long term efficacy in the control of junctional ectopic tachycardia.
Tolerability and Safety
The overall incidence of cardiovascular adverse effects reported in association with propafenone ranges from 13 to 27%. As with other antiarrhythmic agents, propafenone can have a proarrhythmic effect. However, the definition of the term proarrhythmia alters between studies and accordingly the reported incidence of proarrhythmia with each agent is variable. Ventricular proarrhythmias, detected by invasive or noninvasive techniques in clinical studies, were reported in 8 to 19% of patients with malignant ventricular arrhythmias, although lower rates of around 5% were cited in 2 large reports involving over 600 patients each. The incidence of late proarrhythmic events with propafenone is unknown. A rapid ventricular response following propafenone treatment in patients with paroxysmal atrial fibrillation has been reported. Conduction disturbances, including bundle branch block, atrioventricular block, and sinus node dysfunction have been reported in propafenone recipients; the overall reported incidence of conduction disturbances after long term propafenone treatment was approximately 8%. New or exacerbated congestive heart failure has been documented in 3 to 5% of propafenone recipients; in one analysis, the incidence of congestive heart failure was almost twice as high in patients with a history of heart failure as in those without.
Neurological effects (dizziness, taste disturbances, blurred vision, headache and paraesthesias) and gastrointestinal effects (nausea, vomiting, anorexia and constipation) constitute the most commonly reported noncardiac adverse effects with propafenone. The overall incidence rate of noncardiac effects has been reported to be 14%. The weak nonselective β-adrenoceptor antagonist activity of propafenone may also exacerbate symptoms in asthmatic patients.
Propafenone overdosage (up to 9000mg) has been associated with convulsions, hypotension and cardiac conduction abnormalities. Overdosage has resulted in residual cardiac toxicity in 1 patient and has proved fatal in isolated cases. Monitoring in intensive care for 24 hours is recommended for all patients accidentally receiving propafenone doses in excess of 1g.
Drug Interactions
Since propafenone is metabolised by cytochromes CYP2D6, CYP3A3/4 and CYP1A2, there is potential for interactions with other agents which are substrates or inhibitors of the same enzymes. Interactions with propafenone attributed to altered hepatic metabolism have been documented with phenobarbital, metoprolol, propranolol, warfarin and quinidine. Further, increased plasma concentrations of cyclosporin, theophylline, cimetidine and desipramine during coadministration of propafenone and reduced concentrations of propafenone with concomitant rifampicin have been described in individual cases.
Increased digoxin plasma concentrations during concomitant treatment with propafenone have been documented in a number of studies, but with only 1 case of digoxin toxicity. The exact mechanism of this interaction is uncertain.
Dosage and Administration
The standard oral dose range for propafenone is 150 to 300mg 8-hourly, with 450 mg/day being the usual starting dose. A minimum interval of 3 to 4 days should be allowed before increasing the drug dose. Oral loading doses should be avoided. Intravenous doses of propafenone 1 to 2.5 mg/kg have been used successfully in the control of most arrhythmia types. For continuous intravenous infusion, maintenance doses of propafenone 0.007 to 0.014 mg/kg/min have been recommended following loading bolus doses. The maximum daily recommended dose of propafenone is 560mg after intravenous administration and 900mg after oral administration. Dosage reductions may be required in the elderly and in patients with hepatic dysfunction or impaired renal function.
The dose of propafenone should be individualised. Left ventricular dysfunction, conduction disturbances and, if possible, patient metabolic phenotype should be taken into consideration. Propafenone is contraindicated in patients with severe or uncontrolled congestive heart failure, cardiogenic shock, sinoatrial, atrioventricular and intraventricular conduction disorders and sinus node dysfunction in the absence of a pacemaker, severe bradycardia, severe hypotension, bronchospastic disorders, marked electrolyte imbalance and severe hepatic failure. Since the stimulation threshold of permanent pacemakers may be increased during propafenone therapy, existing pacemaker thresholds should be re-evaluated after initiation of treatment. Propafenone is not yet recommended for use in children. Propafenone should be avoided in patients with myasthenia gravis. Warfarin dosage reductions may be necessary during coadministration with propafenone.
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Various sections of the manuscript reviewed by: E. Burgess, Foothills Hospital, Calgary, Alberta, Canada; R. W.F. Campbell, Academic Cardiology, New Medical School, Newcastle Upon Tyne, England; A. Capucci, Universita Delgi Studi di Bologna, Istituto di Malattie dell’Apparato Cardiovascolare, Bologna, Italy; C.L. Case, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, South Carolina, USA; G.L-Y. Chan, University Hospital, Vancouver, British Columbia, Canada; I. Crozier, Cardiology Department, The Princess Margaret Hospital, Christchurch, New Zealand; H. Dinh, Cardiology Division, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; W.H. Frishman, Montefiore Medical Center, The Jack D. Weiler Hospital of the Albert Einstein College of Medicine Division, Bronx, New York, USA; H. Inoue, The Second Department of Internal Medicine, Faculty of Medicine, University of Tokyo, Tokyo, Japan; M. Kohlhardt, Albert-Ludwigs-Universität, Physiologisches Institut, Freiburg, Federal Republic of Germany; H.K. Kroemer, Dr Margarete Fischer-Bosch-Institut für Klinische Pharmakologie, Stuttgart, Federal Republic of Germany; T. Ozawa, Department of Biochemical Chemistry, University of Nagoya, Nagoya, Japan; D.M. Salerno, Division of Cardiology, Hennepin County Medical Center, Minneapolis, Minnesota, USA; G. Stark, Medizinische Klinik, Karl-Franzens-Universität, Graz, Austria; J. Till, Pacing and Electrophysiology, Royal Brompton and National Heart Hospital, London, England; C. Valenzuela, Instituto de Farmacologia y Toxicologia, Cludad Universitaria, Universidad Complutense de Madrid, Madrid, Spain.
An erratum to this article is available at http://dx.doi.org/10.1007/BF03259104.
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Bryson, H.M., Palmer, K.J., Langtry, H.D. et al. Propafenone. Drugs 45, 85–130 (1993). https://doi.org/10.2165/00003495-199345010-00008
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DOI: https://doi.org/10.2165/00003495-199345010-00008