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Atrial Fibrillation and the Pharmacological Treatment: the Role of Propafenone

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Atrial Fibrillation and the Pharmacological Treatment: the Role of Propafenone European Review for Medical and Pharmacological Sciences 2012; 16: 242-253 Atrial fibrillation and the pharmacological treatment: the role of propafenone A. SESTITO, E. MOLINA* Department of Cardiology, School of Medicine, Catholic University of the Sacred Heart, Rome (Italy) *Department of Pharmacology, School of Medicine, University of Parma (Italy) Abstract. – Background: Atrial fibrillation Introduction is the most frequent cardiac rhythm disturbance, with prevalence increasing with age. This disease Atrial fibrillation is a major clinical problem is a major risk factor for ischaemic stroke. The and the most frequently occurring cardiac rhythm costs resulting from atrial fibrillation are really 1-6 impressive. Pharmacological agents are the first disturbance . Its prevalence increases with age: line therapy for the management of atrial fibrilla- 2-3‰ between 25 and 35 years, 30-40‰ be- tion. Antiarrhythmic drugs are used to terminate tween 55 and 65 years, 50-90‰ between 62 and arrhythmias, as acute treatment for conversion of 90 years1-3,5. The prevalence of atrial fibrillation recent onset atrial fibrillation, and to maintain si- is expected to increase for several factors, first of nus rhythm, as chronic therapy for prevention of all for the progressive increase in longevity of atrial fibrillation recurrences. Among antiarrhyth- 1,2,6 mic agents, drugs that inhibit early sodium cur- worldwide populations . According to a 2005 6 rent (as propafenone) are proven effective in atri- estimate , in USA there were 3.03 millions of al fibrillation. In this review, the most relevant da- atrial fibrillation patients and this figure could ta on propafenone are provided. reach 7.56 millions in 2050. Discussion: The development of a sustained- Atrial fibrillation is a strong risk factor for is- release formulation of propafenone allowed to chaemic stroke (approximately 3- to 5-fold ex- reduce the wide fluctuations in plasma levels ob- served with the immediate release preparation, cess risk), with associated clinical problems and improving compliance and adherence to therapy, increased mortality rates (1.5- to 1.9-fold mortal- by simplifying the dosing regimen from 3 to 2 ity risk)2-4,6. daily doses. Propafenone resulted an effective Together with its complications, atrial fibrilla- measure as acute treatment for conversion of re- tion is a major cause of health care consumption, cent onset atrial fibrillation, and to maintain si- costs and poor quality of life6,7. The costs result- nus rhythm, as chronic therapy for prevention of ing from atrial fibrillation are really impres- atrial fibrillation recurrences. In several clinical 2,3,5 studies, strong increases of arrhythmia-free peri- sive . In USA it has been estimated that this ods as well as marked increases in time to recur- disease is responsible for more than 1 million rence of symptomatic atrial fibrillation, such as days of hospitalization per year5. paroxysmal supraventricular tachycardia and Even if the pathophysiology of atrial fibrillation paroxysmal atrial fibrillation were observed. In is not yet completely understood, there is evidence particular, well-designed clinical studies demon- that the cardiac remodeling plays a major role in the strated in large patient populations the efficacy of 4 propafenone at several doses. At the suggested disease process . A high number of factors respon- doses propafenone is usually well tolerated. sible for onset of atrial fibrillation, usually indicated Conclusion: The risk of increased occurrence as “triggers”, has been recognized8-10. Among them, of regular supraventricular arrhythmia or paroxys- sympathetic or parasympathetic stimulation, brady- mal supraventricular tachycardia has been over- cardia, atrial premature beats, tachycardia, accesso- estimated for propafenone, because this adverse ry atrio-ventricular pathways, and acute atrial event was seen in all treatment groups, including stretch are included8. In particular, it has been placebo, with the same (and low) frequency. demonstrated that a wide part of atrial premature Key Words: beats, involved in paroxysms of atrial fibrillation, originate in the pulmonary veins9. The intrinsic car- Atrial fibrillation (AF), Acute onset AF, Prevention of diac autonomic nervous system is thought to play a AF recurrences, Antiarrhythmic drugs, Propafenone. crucial role in the atrial remodeling process10. 242 Corresponding Author: Alfonso Sestito, MD; e-mail: [email protected] Atrial fibrillation and the pharmacological treatment: the role of propafenone The clinical relevance and the high costs of file of efficacy, safety and convenience. Table II atrial fibrillation account for the need of effective reports some observations on main antiarrhyth- drug treatment5. mic agents6,14-16. As for the management of atrial fibrillation, We can state, therefore, that propafenone, the main therapeutic strategies include: thanks to its clinical efficacy associated to a good safety (in particular to a reduced risk of proar- • Rate control; rhythmic effect), can represent an important mea- • Termination of arrhythmia; sure in the management of atrial fibrillation pa- • Prevention of recurrences; tients not showing cardiac structural alterations. • Prevention of thromboembolic events11. In addition, this drug, due to the availability of vials for intravenous use, immediate release Pharmacological agents are the first line thera- tablets, and sustained release capsules, allows to py for rhythm management in atrial fibrillation1,6. develop various treatment schedules and to adapt Antiarrhythmic drugs are used to terminate ar- the therapy according to different needs. rhythmias and maintain sinus rhythm6,11. Efficacy and safety profiles are extremely im- Focus on Propafenone portant issues in the choice of an antiarrhythmic Propafenone is a powerful Ic class antiarrhyth- agent, but also the dosing convenience (allowing mic agent, with demonstrated effectiveness high patient compliance) should be taken in due against a variety of cardiac arrhythmias12-14. This account11. According to current guidelines, it is agent shows a marked inhibitory effect on the suggested to select an antiarrhythmic drug con- sodium channel and some beta-blocking activi- sidering some main factors, in order to identify ty5,14-17. the best therapeutic strategy: The original formulation of oral propafenone immediate release was rapidly absorbed by gas- • Symptoms presentation; trointestinal tract and metabolized by liver, • Atrial fibrillation characteristics; needing a 3 times daily administration13,17. • Presence of cardiovascular diseases; Propafenone 150-300 mg tid is associated to a • Patient age and medical conditions; half-life of 5-7 hours, wide fluctuations in peak- • Treatment goals6. trough plasma concentrations, and a marked in- terindividual variability17,19. To solve these prob- Among antiarrhythmic agents, drugs that in- lems, a sustained-release preparation (SR) has hibit early sodium current (as propafenone and been subsequently developed, improving compli- flecainide) are proven effective in atrial fibrilla- ance, efficacy, and safety12,13,17,18. Thank to its tion1,5,12,13. The most widely used antiarrhythmic prolonged half-life (12 hours), this latter drugs6 are listed in Table I. propafenone formulation allows a twice daily ad- According to most recent guidelines and up- ministration, with better compliance and adher- dated meta-analyses, as well as to the Author’s ence to therapy12,13,17,18. In addition, based on the personal caseload, it is possible to anticipate official data on propafenone pharmacokinetics some general considerations on the pharmaco- derived from SPC, we underline the importance logical approach to atrial fibrillation. of the curves reported in Figure 1. As for other chronic treatments, also for an- Propafenone undergoes extensive hepatic me- tiarrhythmic drugs the choice of the proper thera- tabolization: the main products of oxidative me- py should balance at the best efficacy and safety. tabolism are 5-hydroxy-propafenone and hy- The group of antiarrhythmic drugs includes droxy-methoxy-propafenone5,17. In particular, 5- different molecules showing each a typical pro- hydroxy-propafenone shows a pharmacodynamic Table I. Main antiarrhythmics drugs. Sodium channel blockers Potassium channel blockers Class Ia Disopyramide, procainamide, quinidine Class III Amiodarone, dofetilide*, ibutilide, sotalol Class Ic Flecainide, propafenone *USA only. (Adapted from 6). 243 A. Sestito, E. Molina Table II. Selected data on main antiarrhythmics. Some drugs, relatively more recent (as propafenone, flecainide, procainamide and sotalol), are at least as effective as some less recent agents, as quinidine and disopyramide. At the same time, propafenone, flecainide, procainamide and sotalol are better tolerated than quinidine and disopyramide. Among the most active agents, the proarrhythmic effect is less frequent with propafenone and amiodarone. As for proarrhythmic effect, no statistically significant differences were found when comparing propafenone and amio- darone with placebo. In particular, in the Ic class propafenone shows a lower frequency of proarrhythmic effects as compared with flecainide. Propafenone is a powerful Ic antiarrhythmic agent, widely used for sinus rhythm restoration and maintenance. In meta- and mixed-analyses, sotalol and propafenone were evaluated as for the safety profile in the widest patients popu- lations (more than 1,000 patients), as compared with amiodarone
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