Cardiovascular Journal of Africa: Vol 32 No 6 (NOVEMBER/DECEMBER 2021)
CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 6, November/December 2021 330 AFRICA 50%. Direct comparison between amiodarone and class IA, IC or other class III anti-arrhythmic drugs showed better results for amiodarone in preventing recurrences of AF. In the Canadian trial of AF (CTAF), 403 patients with paroxysmal and persistent AF with at least one episode in the preceding six months were randomly assigned to receive amiodarone, sotalol or propafenone. 60 For the first 14 days, the amiodarone dose was 10 mg/kg body weight daily, followed by 300 mg per day for four weeks, after which a maintenance dose of 200 mg each day was prescribed. During a mean follow up of 16 months, 35% of patients taking amiodarone had AF recurrence, compared with 63% of the group treated with propafenone or sotalol ( p < 0.001). 60 In SAFE-T (Sotalol Amiodarone Atrial Fibrillation Efficacy Trial) 665 patients with persistent AF were randomised to amiodarone, sotalol or placebo. 54 Amiodarone was given at a dose of 800 mg daily for 14 days, followed by 600 mg for the next 14 days, and 300 mg per day for the first year, after which a dose of 200 mg per day was prescribed. After 28 days of treatment, amiodarone and sotalol were equally effective in AF conversion to SR (27.1 vs 24.1%, respectively, p = 0.45). Amiodarone was however superior for SR maintenance with a longer time to first AF recurrence compared with sotalol (median 487 vs 74 days, p = 0.002) ( p = 0.002) or placebo (median 487 vs 6 days, p = 0.001). 54 Similarly, a sub-study of the AFFIRM trial found that amiodarone was more successful in maintaining SR after a follow up of one year compared with sotalol (60 vs 38%, p = 0.002) or with class I agents (62 vs 23%, p < 0.001). 58 Amiodarone was also compared against dronaderone in the DIONYSOS (Double-Blind Trial to Evaluate the Efficacy and Safety of Dronaderone) ramdomised, controlled trial that enrolled 504 patients with persistent AF. 50 Amiodarone was given to 255 patients at a dose of 600 mg once daily for the first 28 days and 200 mg once daily thereafter, while dronaderone’s dose was 400 mg twice a day. The primary composite endpoint included AF recurrence or premature study discontinuation and the result was 75.1 vs 58.8% for dronaderone and amiodarone, respectively [hazard ratio (HR) 1.59, p < 0.001]. At 12 months of treatment, amiodarone was associated with lower risk of AF recurrence (42 vs 63.5%). On the other hand amiodarone had a worse safety profile than dronaderone (13.3 vs 10.4%) with less premature drug discontinuation for patients with dronaderone versus amiodarone (HR 0.76, p = 0.227). A recent study showed that dronaderone might be a good therapeutic option to replace amiodarone in selected Table 3. The most important randomised and non-randomised trials on the use of amiodarone vs other anti-arrhythmic drugs for the prevention of AF recurrences after cardioversion Trial AADs evaluated Number Mean age (years) Main results Fragakis 2012 48 Amiodarone vs amiodarone + ranolazine for conversion of recent-onset AF 51 63 65 vs 88% conversion to SR Santas 2012 49 Amiodarone + irbesartan vs irbesartan after cardioversion, for maintenance of SR 94 64 26.7 vs 55.1% AF recurrence at 18 months Freemantle 2011 47 Amiodarone vs dronedarone vs sotalol vs flecainide vs propafenone 6 629 61 41.9 vs 63.4% dronaderone 37.7 vs 51.9% sotalol 31 vs 32% flecainide 40 vs 47% propafenone AF recurrence DYONISOS 2010 50 Amiodarone vs dronedarone for persistent AF 504 64 42 vs 63.5% AF recurrence at 12 months Pitagora trial 2008 51 Amiodarone vs flecainide/propafenone vs sotalol for AF in patients with pacemakers for sinus node disease 176 72 40 vs 28 vs 24% SR at 1 year Vijayalaskshmi 2006 52 Amiodarone vs sotalol for patients with persistent AF planned for DCC 94 64 81 vs 92% conversion to SR 63 vs 39% SR at 6 months Niu 2006 53 Amiodarone vs sotalol for AF 102 56 78.4 vs 70.6% conversion to SR 67.5 vs 41.7% SR at 12 months 44.4 vs 26.7% SR at 24 months SAFE-T 2005 54 Amiodarone vs sotalol for AF 665 67 27.1 vs 24.2% spontaneous conversion 27.7 vs 26.5% failed DCC 487 vs 74 days to AF recurrence Kochiadakis 2004 55 Amiodarone vs propafenone for maintenance of SR 146 63 34.7 vs 44.59% AF recurrence at 9.8 and 3.8 months, respectively Kanoupakis 2004 56 Amiodarone vs carvedilol for conversion and maintenance of SR 145 65 93.3 vs 91.5% conversion to SR 16.6 vs 27.9% AF recurrence at 4 weeks Manios 2003 57 Amiodarone + diltiazem for conversion and maintenance of SR for persistent AF 111 64 100 vs 85% conversion to SR 26.4 vs 53.3% AF recurrence at 6 weeks AFFIRM sub-study 2003 58 Amiodarone vs sotalol vs flecainide/propafenone after cardioversion in patients with persistent AF 410 69 62 vs 38 vs 23% in SR at 1 year Kochiadakis 2000 59 Amiodarone vs sotalol for recurrent, symptomatic AF 186 63 47 vs 77% AF recurrence at 6 and 8 months, respectively CTAF 2000 60 Amiodarone vs sotalol or propafenone to prevent recurrences of AF 403 65 35 vs 63% AF recurrence at 16 months Martinez-Marcos 2000 61 Amiodarone vs propafenone vs flecainide for paroxysmal AF 150 60 64 vs 72 vs 90% in SR at 12 hours Villani 1992 62 Amiodarone vs disopyramide for prevention of AF recurrences 76 65 32 vs 57% AF recurrence at 13 months Zehender 1992 63 Amiodarone vs quinidine + verapamil for persistent AF 40 58 60 vs 55% in SR at 2 years Martin 1986 64 Amiodarone vs disopyramide for paroxysmal AF 70 69 79 vs 55% in SR at 16 months Vitolo 1981 65 Amiodarone vs quinidine in the prophylaxis of AF after DCC 54 53 78.5 vs 46.1% in SR at 6 months AAD, anti-arrhythmic drug; AF, atrial fibrillation; SR, sinus rhythm; DCC, direct-current conversion.
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