| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | dofetilide | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIAMOND MI, 1997 | dofetilide vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| DIAMOND MI, 1997 | dofetilide (n=-9) vs. placebo (n=-9) | patients with acute myocardial infarction within 7 days and left ventricular systolic dysfunction (EF <= 35%) | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: >12 months |
|
| acute myocardial infarction | magnesium | not classified | versus placebo or control No demonstrated result for efficacy magnesium inferior to control in terms of Heart failure in ISIS-4, 1995 magnesium inferior to control in terms of Profound hypotension in ISIS-4, 1995 magnesium inferior to control in terms of II-III heart block in ISIS-4, 1995 magnesium inferior to control in terms of Cardiogenic shock in ISIS-4, 1995 magnesium inferior to control in terms of Bradycardia in ISIS-4, 1995 magnesium inferior to placebo in terms of Heart failure in Morton, 1984 magnesium inferior to placebo in terms of II-III heart block in Morton, 1984 magnesium inferior to placebo in terms of Bradycardia in Woods, 1992 | 25 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Abraham, 1987 | magnesium vs placebo | | | Ventricular tachycardia 0.41 [0.11; 1.49] All cause death 0.96 [0.06; 14.87] Profound hypotension 0.48 [0.04; 5.11] Ventricular fibrillation 0.00 [0.00; NaN] Cardiogenic shock 0.96 [0.06; 14.87] Bradycardia ∞ [NaN; ∞] | | ISIS-4, 1995 | magnesium vs control | Ventricular fibrillation 0.91 [0.84; 0.99] | Heart failure 1.07 [1.03; 1.11] Profound hypotension 1.11 [1.07; 1.16] II-III heart block 1.07 [1.03; 1.11] Cardiogenic shock 1.11 [1.03; 1.20] Bradycardia 7.42 [4.06; 13.56] | All cause death 1.06 [0.98; 1.14] | | MAGIC, 2000 | magnesium vs placebo | | | All cause death 1.00 [0.89; 1.13] Heart failure 1.06 [0.95; 1.17] II-III heart block 1.06 [0.95; 1.17] severe arrhythmia 1.01 [0.81; 1.26] | | Bhargava, 1995 | magnesium vs placebo | Ventricular tachycardia 0.48 [0.29; 0.78] | | All cause death 0.95 [0.20; 4.42] Ventricular fibrillation 0.63 [0.11; 3.58] Cardiogenic shock 0.00 [0.00; NaN] Bradycardia 1.90 [0.18; 20.10] | | Ceremuzynski, 1989 | magnesium vs placebo | Ventricular tachycardia 0.36 [0.18; 0.70] | | All cause death 0.31 [0.03; 2.74] Ventricular fibrillation 0.00 [0.00; NaN] Cardiogenic shock ∞ [NaN; ∞] | | Chen, 1991 | magnesium vs placebo | severe arrhythmia 0.35 [0.17; 0.70] | | Ventricular tachycardia 0.00 [0.00; NaN] Ventricular fibrillation 0.00 [0.00; NaN] | | Feldstedt, 1991 | magnesium vs placebo | | | Ventricular tachycardia ∞ [NaN; ∞] All cause death 1.23 [0.50; 3.04] Heart failure 1.38 [0.45; 4.25] Ventricular fibrillation 0.66 [0.11; 3.88] II-III heart block 1.38 [0.45; 4.25] | | Gyamlani, 2000 | magnesium vs placebo | Ventricular tachycardia 0.27 [0.08; 0.92] All cause death 0.20 [0.05; 0.87] Heart failure 0.60 [0.36; 1.00] II-III heart block 0.60 [0.36; 1.00] | | Ventricular fibrillation 0.00 [0.00; NaN] Cardiogenic shock 0.40 [0.08; 1.97] Bradycardia ∞ [NaN; ∞] | | Ising, 1990 | magnesium vs placebo | | | | | Morton, 1984 | magnesium vs placebo | | Heart failure 2.52 [1.01; 6.30] II-III heart block 2.52 [1.01; 6.30] | All cause death 0.45 [0.04; 4.76] Profound hypotension ∞ [NaN; ∞] Ventricular fibrillation 1.80 [0.17; 19.02] | | Nakashima, 2004 | magnesium vs placebo | | | All cause death 0.34 [0.04; 3.22] Heart failure 0.66 [0.39; 1.10] Ventricular fibrillation 1.79 [0.54; 5.90] II-III heart block 0.66 [0.39; 1.10] Cardiogenic shock 0.85 [0.39; 1.87] | | Parikka, 1990 | magnesium vs placebo | | | Heart failure 0.98 [0.38; 2.55] II-III heart block 0.98 [0.38; 2.55] | | Raghu, 1999 | magnesium vs placebo | All cause death 0.36 [0.15; 0.88] | | Bradycardia ∞ [NaN; ∞] | | Rasmussen, 1986 | magnesium vs placebo | | | Ventricular tachycardia 0.93 [0.38; 2.28] All cause death 0.38 [0.13; 1.08] Heart failure 1.32 [0.08; 20.67] II-III heart block 1.32 [0.08; 20.67] Cardiogenic shock 0.00 [0.00; NaN] severe arrhythmia 1.13 [0.57; 2.25] Bradycardia 0.44 [0.09; 2.10] | | Santoro, 2000 | magnesium vs placebo | | | Ventricular tachycardia 1.64 [0.83; 3.22] All cause death 0.00 [0.00; NaN] Heart failure 1.20 [0.38; 3.76] II-III heart block 1.20 [0.38; 3.76] Bradycardia ∞ [NaN; ∞] | | Shechter, 1990 | magnesium vs placebo | All cause death 0.12 [0.02; 0.90] | | Heart failure 0.84 [0.48; 1.46] II-III heart block 1.06 [0.55; 2.06] Cardiogenic shock 0.18 [0.02; 1.42] severe arrhythmia 0.71 [0.43; 1.17] | | Shechter, 1991 | magnesium vs placebo | | | All cause death 0.60 [0.12; 2.93] II-III heart block 0.71 [0.31; 1.64] Cardiogenic shock 0.30 [0.04; 2.46] severe arrhythmia 0.68 [0.36; 1.30] | | Shechter, 1995 | magnesium vs placebo | All cause death 0.24 [0.08; 0.69] Cardiogenic shock 0.09 [0.01; 0.70] | | II-III heart block 0.84 [0.48; 1.46] severe arrhythmia 0.68 [0.45; 1.02] | | Singh, 1990 | magnesium vs placebo | severe arrhythmia 0.37 [0.20; 0.67] | | All cause death 0.55 [0.21; 1.40] Profound hypotension 1.67 [0.79; 3.54] Cardiogenic shock 1.00 [0.26; 3.83] | | Smith, 1986 | magnesium vs placebo | | | All cause death 0.29 [0.06; 1.35] severe arrhythmia 0.72 [0.24; 2.19] | | Thogersen, 1995 | magnesium vs placebo | | | All cause death 0.47 [0.14; 1.52] | | Urek, 1996 | magnesium vs placebo | | | All cause death ∞ [NaN; ∞] II-III heart block 0.97 [0.06; 14.78] severe arrhythmia 0.62 [0.28; 1.38] | | Woods, 1992 | magnesium vs placebo | All cause death 0.76 [0.59; 0.99] Heart failure 0.75 [0.61; 0.93] II-III heart block 0.75 [0.61; 0.93] | Bradycardia 1.34 [1.04; 1.73] | Profound hypotension 1.00 [0.70; 1.43] | | Wu, 1992 | magnesium vs control | Ventricular tachycardia 0.29 [0.11; 0.78] All cause death 0.34 [0.12; 0.93] Ventricular fibrillation 0.12 [0.01; 0.93] severe arrhythmia 0.39 [0.23; 0.64] | | Heart failure 0.86 [0.48; 1.55] II-III heart block 0.86 [0.48; 1.55] | | Zhu, 2002 | magnesium vs control | All cause death 0.66 [0.52; 0.85] Ventricular fibrillation 0.52 [0.35; 0.80] | | Cardiogenic shock 0.66 [0.42; 1.03] |
| Trial | Treatments | Patients | Method |
|---|
| Abraham, 1987 | 2.4g of magnesium sulfate in 50 ml of 5% glucose solution intravenously over a 20 minutes period for 3 days (n=48) vs. 50 ml of 5% glucose solution alone, imag (n=46) | patients with AMI | double blind Parallel groups Sample size: 48/46 Primary endpoint: FU duration: | | ISIS-4, 1995 | 24 h of intravenous magnesium sulphate (8 mmol initial bonus injection over about 15
minutes followed by 72 mmol in about 50 mLinfused over 24 h)4 (n=29011) vs. no magnesium infusion (n=29030) | patients entering 1086 hospitals up to 24 h (median 8 h) after the onset of suspected acute myocardial
infarction with no clear contraindications4 | open Parallel groups Sample size: 29011/29030 Primary endpoint: FU duration: | | MAGIC, 2000 | 2 g intravenous bolus of MgSO4 over 15 minutes, followed by a 17 g infusion of MgSO4
over 24 h (n=3113) vs. matched intravenous bolus and 24 h infusion of sterile waterndºã (n=3100) | AMi patients within 6 h of onset of symptomsm | double blind Parallel groups Sample size: 3113/3100 Primary endpoint: FU duration: | | Bhargava, 1995 | 8 mmol magnesium sulphate over 5 min followed by 65 mmol over 24-h infusion (n=40) vs. isotonic saline infusion (n=38) | proven AMI patients with chest pain of 1-6h | double blind Parallel groups Sample size: 40/38 Primary endpoint: FU duration: | | Ceremuzynski, 1989 | 8 g MgSO4 in 500 mL 15% glucose for 24 h intravenouslypj (n=25) vs. conventional treatmenton (n=23) | patients with AMI within 12 h from onset of symptomslypj | NA Parallel groups Sample size: 25/23 Primary endpoint: FU duration: | | Chen, 1991 | MgSO4 2g/day for 3 daysn (n=32) vs. 5% glucose (n=30) | patients with AMI | open blind assessor Parallel groups Sample size: 32/30 Primary endpoint: FU duration: | | Feldstedt, 1991 | continuous infusion of 80 mmol magnesium chloride in 1000 mL dextrose˜K (n=150) vs. matching placebo (n=148) | patients, aged 75 y or less, with suspected AMI less than 8 h+—² | double blind Parallel groups Sample size: 150/148 Primary endpoint: FU duration: | | Gyamlani, 2000 | magnesium 12g (50 mmol) in the first 24h, 3g (12 mmol) in the second 24h used within 2h after admission and within 30 minutes of thrombolytic therapy™ (n=50) vs. equal volume of isotonic glucose (n=50) | patients with proven AMI | double blind Parallel groups Sample size: 50/50 Primary endpoint: FU duration: | | Ising, 1990 | 81 mval/daymagnesium sulphate infusion 13+/-9h after the onset of severe pain for 3 days (n=22) vs. 80 mval/day NaCl infusion for 3 daysimag (n=20) | patients with AMI | open Parallel groups Sample size: 22/20 Primary endpoint: FU duration: | | Morton, 1984 | 36 h intravenous infusion of magnesium sulphate (0.75 mEq/kg/body weight/12 h). (n=-9) vs. saline solution infusion (n=-9) | patients with AMI within 8 h of onsetmag | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | | Nakashima, 2004 | bolus injection of 8 mmol of magnesium followed by an infusion of 24 mmol over 24 h (n=89) vs. equivalent amount of normal saline, imag (n=91) | patients with successful PCI weree, imag | double blind Parallel groups Sample size: 89/91 Primary endpoint: FU duration: | | Parikka, 1990 | 8mmol MgSO4 in 10 min, 62 mmol in 24hmag (n=31) vs. NaCl ¯B (n=26) | patients with < 12 h from onset of chest pain AMImage/pj | double blind Parallel groups Sample size: 31/26 Primary endpoint: FU duration: | | Raghu, 1999 | 18 g (75.6 mmol) of Mg sulphate over 24 h started immediately after completion of thrombolytic
therapy (n=181) vs. equivalent amount of salinexbitm (n=169) | confirmed AMI < 6 h from the onset of symptomsce | double blind Parallel groups Sample size: 181/169 Primary endpoint: FU duration: | | Rasmussen, 1986 | 50 mmol MgCl2 during the first 24 h, 12 mmol during the second 24 h (n=56) vs. isotonic glucose (n=74) | patients with suspected AMIxbitm | double blind Parallel groups Sample size: 56/74 Primary endpoint: FU duration: | | Santoro, 2000 | MgSO4 7 g (28 mmol) with 5 hon (n=75) vs. matching saline solution (n=75) | | double blind Parallel groups Sample size: 75/75 Primary endpoint: FU duration: | | Shechter, 1990 | magnesium 22 g (91.6 mmol) within 48 h (67 mmol within first 24 h). (n=50) vs. isotonic glucose. (n=53) | patients with admission diagnosis of AMI | double blind Parallel groups Sample size: 50/53 Primary endpoint: FU duration: | | Shechter, 1991 | 22 g (91.6 mmol) within 48 h (67 mmol within first 24 h). (n=21) vs. isotonic glucose. (n=25) | patients with documented AMIbitm | double blind Parallel groups Sample size: 21/25 Primary endpoint: FU duration: | | Shechter, 1995 | magnesium 22 g (91.6mmol) within 48 h (67mmol within first 24 h)pj (n=96) vs. isotonic glucose (n=98) | suspected with AMI and considered unsuitable candidates for thrombolysis | double blind Parallel groups Sample size: 96/98 Primary endpoint: FU duration: | | Singh, 1990 | 5 g (8.12 mmol) of MgSO4 daily for 4 daysptomsce (n=-9) vs. 2% dextrose solution for 3 daysm (n=-9) | patients suspected with AMI within 8-12h of the onset of MI | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | | Smith, 1986 | 65 mmol MgSO4 given over 24 h (n=92) vs. Saline (n=93) | patients with suspected AMI h.tm | double blind Parallel groups Sample size: 92/93 Primary endpoint: FU duration: | | Thogersen, 1995 | magensium 50 mmol within 24 h (n=130) vs. isotonic NaCl. (n=122) | patients with suspected AMI | double blind Parallel groups Sample size: 130/122 Primary endpoint: FU duration: | | Urek, 1996 | 17 g MgSO4 with first 24 h.xbitm (n=31) vs. saline. (n=30) | patients with documented AMIbitm | double blind Parallel groups Sample size: 31/30 Primary endpoint: FU duration: | | Woods, 1992 | magnesium 8 mmol over 5 min, 65 mmol over 24h imag (n=1159) vs. physiological saline hon (n=1157) | patients with suspected AMI in the preceding 24h | double blind Parallel groups Sample size: 1159/1157 Primary endpoint: FU duration: | | Wu, 1992 | 2.5 g MgSO4 once or twice a day for 7-14 dayssce (n=125) vs. usual care (n=102) | suspected AMI | double blind Parallel groups Sample size: 125/102 Primary endpoint: FU duration: | | Zhu, 2002 | 100 mL (4 g) potassium-magnesium aspartate IV. for the first day, 50 ml for rest 4 datio (n=1691) vs. routine AMI treatmentƒkB (n=1488) | AMI | open Parallel groups Sample size: 1691/1488 Primary endpoint: FU duration: |
|
| acute myocardial infarction | moricizine | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CAST II (early treatment), 1992 | moricizine vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| CAST II (early treatment), 1992 | moricizine for 14 days (n=665) vs. placebo (n=660) | acute myocardial infarction | double blind Parallel groups Sample size: 665/660 Primary endpoint: mortality FU duration: 14 days |
|
| atrial fibrillation | amiodarone | not classified | versus placebo or control No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Channer, 2004 | amiodarone vs placebo | Atrial fibrillation recurrence 0.54 [0.41; 0.69] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 4.98 [0.65; 38.29] Pro-arrhythmia ∞ [NaN; ∞] | | GEFACA, 2001 | amiodarone vs placebo | Atrial fibrillation recurrence 0.32 [0.17; 0.60] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] | | Kochiadakis (amiodarone vs placebo), 2000 | amiodarone vs placebo | Atrial fibrillation recurrence 0.53 [0.39; 0.73] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] | | SAFE-T (amiodarone vs placebo), 2005 | amiodarone vs placebo | Atrial fibrillation recurrence 0.58 [0.50; 0.66] | | all cause mortality 2.14 [0.62; 7.39] Pro-arrhythmia 1.48 [0.30; 7.25] |
| Trial | Treatments | Patients | Method |
|---|
| Channer, 2004 | Amiodarone 200 mg/d (n=61) vs. placebo (n=38) | patients with Persistent AF | double blind Parallel groups Sample size: 61/38 Primary endpoint: FU duration: 12 months | | GEFACA, 2001 | Amiodarone 200 mg/d (n=35) vs. placebo (n=15) | Persistent AF lasting > 2 months | double blind Parallel groups Sample size: 35/15 Primary endpoint: FU duration: 16 months | | Kochiadakis (amiodarone vs placebo), 2000 | Amiodarone 200 mg/d (n=65) vs. placebo (n=60) | Any documented symptomatic previous or persistent AF | single Parallel groups Sample size: 65/60 Primary endpoint: FU duration: 24 months | | SAFE-T (amiodarone vs placebo), 2005 | Amiodarone 300 mg/d (n=267) vs. placebo (n=137) | Persistent AF lasting 3 days to 1 year | double blind Parallel groups Sample size: 267/137 Primary endpoint: recurrence of atrial fibrillation FU duration: 12 months |
|
| atrial fibrillation | amiodarone | not classified | versus Class I No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AFFIRM Substudy (amiodarone vs class I drugs), 2003 | amiodarone vs class I drugs | all cause mortality 0.42 [0.21; 0.83] Withdrawals due to adverse effects 0.33 [0.21; 0.53] Pro-arrhythmia 0.20 [0.08; 0.51] Atrial fibrillation recurrence 0.66 [0.55; 0.80] | | Cardiac arrhythmic death 0.63 [0.19; 2.08] | | AFFIRM Substudy (sotalol vs class I drugs), 2003 | amiodarone vs class I drugs | | | |
| Trial | Treatments | Patients | Method |
|---|
| AFFIRM Substudy (amiodarone vs class I drugs), 2003 | Amiodarone 200 mg/d
, (n=106) vs. class I drugs (n=116)
| patients with AF likely to be recurrent and to cause ilness or deathpj
| open Parallel groups Sample size: 106/116 Primary endpoint: success FU duration: 12 months, and 3.8y
| | AFFIRM Substudy (sotalol vs class I drugs), 2003 | Amiodarone 200 mg/d
,
, sotalol (n=-9) vs. class I drugs
(n=-9)
| patients with AF likely to be recurrent and to cause ilness or deathpj
| open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 months, and 3.8y
|
|
| atrial fibrillation | amiodarone | not classified | versus Class Ia No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Villani, 1992 | amiodarone vs disopyramide | Atrial fibrillation recurrence 0.55 [0.35; 0.85] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 0.35 [0.10; 1.18] | | Vitolo, 1981 | amiodarone vs quinidine | Atrial fibrillation recurrence 0.40 [0.18; 0.88] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 0.93 [0.06; 14.10] Pro-arrhythmia 0.93 [0.06; 14.10] |
| Trial | Treatments | Patients | Method |
|---|
| Villani, 1992 | Amiodarone 200 mg/d (n=35) vs. disopyramide 500 mg/d (n=41) | Symptomatic recent-onset AF lasting > 1 hour, being at least the second episode | open Parallel groups Sample size: 35/41 Primary endpoint: FU duration: 14 months | | Vitolo, 1981 | Amiodarone 400 mg/d (n=28) vs. Quinidine 1,2 g/d (n=26) | Any persistent AF | open Parallel groups Sample size: 28/26 Primary endpoint: FU duration: 6 months |
|
| atrial fibrillation | amiodarone | not classified | versus Class Ic No demonstrated result for efficacy amiodarone inferior to propafenone in terms of Withdrawals due to adverse effects in Kochiadakis a, 2004 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Kochiadakis a, 2004 | amiodarone vs propafenone | | Withdrawals due to adverse effects 8.74 [2.09; 36.46] | all cause mortality NaN [NaN; NaN] Pro-arrhythmia 1.03 [0.15; 7.10] Atrial fibrillation recurrence 0.64 [0.41; 1.01] |
| Trial | Treatments | Patients | Method |
|---|
| Kochiadakis a, 2004 | Amiodarone 200 mg/d (n=72) vs. propafenone 450 mg/d (n=74) | Any documented symptomatic previous or persistent AF | single Parallel groups Sample size: 72/74 Primary endpoint: FU duration: 24 months |
|
| atrial fibrillation | amiodarone | not classified | versus Class III No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AFFIRM Substudy (amiodarone vs sotalol), 2003 | amiodarone vs sotalol | Atrial fibrillation recurrence 0.68 [0.54; 0.86] | | all cause mortality 0.60 [0.33; 1.08] Withdrawals due to adverse effects 0.83 [0.47; 1.47] Pro-arrhythmia 0.49 [0.17; 1.42] Cardiac arrhythmic death 0.95 [0.28; 3.22] | | Kochiadakis (amiodarone vs sotalol), 2000 | amiodarone vs sotalol | | | | | SAFE-T (amiodarone vs sotalol), 2005 | amiodarone vs sotalol | | | |
| Trial | Treatments | Patients | Method |
|---|
| AFFIRM Substudy (amiodarone vs sotalol), 2003 | Amiodarone 200 mg/d (n=131) vs. Sotalol 240 mg/d (n=125) | patients with AF likely to be recurrent and to cause ilness or deathpj | open Parallel groups Sample size: 131/125 Primary endpoint: FU duration: mean 3.8y | | Kochiadakis (amiodarone vs sotalol), 2000 | Amiodarone 200 mg/d
, Amiodarone 200 mg/d
(n=65) vs. (n=61)
| Any documented symptomatic previous or persistent AF
| single Parallel groups Sample size: 65/61 Primary endpoint: FU duration: 24 months
| | SAFE-T (amiodarone vs sotalol), 2005 | Amiodarone 300 mg/d
, Amiodarone 300 mg/d
(n=267) vs. (n=261)
| Persistent AF lasting 3 days to 1 year
| double blind Parallel groups Sample size: 267/261 Primary endpoint: FU duration: 12 months
|
|
| atrial fibrillation | Azimilide | not classified | versus placebo or control No demonstrated result for efficacy Azimilide inferior to placebo in terms of Withdrawals due to adverse effects in ASAP, 2003 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ASAP, 2003 | Azimilide vs placebo | | Withdrawals due to adverse effects 2.30 [1.20; 4.39] | all cause mortality 1.23 [0.38; 3.99] Pro-arrhythmia 6.04 [0.78; 46.62] |
| Trial | Treatments | Patients | Method |
|---|
| ASAP, 2003 | Azimilide various doses (35 to 125 mg/d) after pharmacological or electrical cardioversion (n=891) vs. placebo (n=489) | patients with previous AF documented in the last 2 years | double blind Parallel groups Sample size: 891/489 Primary endpoint: FU duration: 6 months |
|
| atrial fibrillation | disopyramide | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Karlson, 1998 | disopyramide vs placebo | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 3.50 [0.77; 15.96] Pro-arrhythmia NaN [NaN; NaN] Atrial fibrillation recurrence 0.75 [0.54; 1.05] | | Lloyd (Disopyramide vs placebo), 1984 | disopyramide vs placebo | | | all cause mortality NaN [NaN; NaN] Pro-arrhythmia NaN [NaN; NaN] Atrial fibrillation recurrence 0.81 [0.53; 1.24] |
| Trial | Treatments | Patients | Method |
|---|
| Karlson, 1998 | Disopyramide 500 mg/d (n=46) vs. palcebo (n=46) | Persistent AF between 6 weeks and 1 year | open Parallel groups Sample size: 46/46 Primary endpoint: FU duration: 12 months | | Lloyd (Disopyramide vs placebo), 1984 | Disopyramide 450 mg/d , (n=29) vs. placebo
(n=25)
| Persistent AF lasting 1 month to 3 years
| double blind Parallel groups Sample size: 29/25 Primary endpoint: FU duration: 6 months
|
|
| atrial fibrillation | disopyramide | not classified | versus Class Ia No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Lloyd (Disopyramide vs quinidine), 1984 | disopyramide vs quinidine | | | |
| Trial | Treatments | Patients | Method |
|---|
| Lloyd (Disopyramide vs quinidine), 1984 | Disopyramide 450 mg/d ,
,
(n=29) vs. placebo
(n=28)
| Persistent AF lasting 1 month to 3 years
| double blind Parallel groups Sample size: 29/28 Primary endpoint: FU duration: 6 months
|
|
| atrial fibrillation | disopyramide | not classified | versus Class Ic No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PRODIS, 1996 | disopyramide vs propafenone | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 0.40 [0.14; 1.19] Pro-arrhythmia 0.81 [0.05; 12.26] Atrial fibrillation recurrence 0.73 [0.37; 1.44] |
| Trial | Treatments | Patients | Method |
|---|
| PRODIS, 1996 | Disopyramide 750 mg/d (n=31) vs. propafenone 900 mg/d (n=25) | Persistent AF | double blind Parallel groups Sample size: 31/25 Primary endpoint: FU duration: 6 months |
|
| atrial fibrillation | dofetilide | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIAMOND, 2001 | dofetilide vs placebo | Atrial fibrillation recurrence 0.62 [0.54; 0.70] | | all cause mortality 0.99 [0.77; 1.29] Pro-arrhythmia ∞ [NaN; ∞] | | SAFIRE-D, 2000 | dofetilide vs placebo | Atrial fibrillation recurrence 0.85 [0.72; 1.00] | | all cause mortality 0.75 [0.19; 2.90] Withdrawals due to adverse effects 1.68 [0.37; 7.59] Pro-arrhythmia 4.48 [0.59; 33.83] |
| Trial | Treatments | Patients | Method |
|---|
| DIAMOND, 2001 | Dofetilide 500 mcg/d5 (n=249) vs. placebo (n=257) | Persistent AF in patients with heart failure or recent myocardial infarction and reduced LVEF | double blind Parallel groups Sample size: 249/257 Primary endpoint: FU duration: 24 months | | SAFIRE-D, 2000 | Dofetilide various doses (250, 500, 1000 mcg/d) (n=182) vs. placebo (n=68) | Persistent AF or AFl lasting 2 weeks to 6 months | double blind Parallel groups Sample size: 182/68 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | dronedarone | not classified | versus placebo or control No demonstrated result for efficacy dronedarone inferior to placebo in terms of Withdrawals due to adverse effects in ATHENA, 2009 dronedarone inferior to placebo in terms of Stroke in PALLAS, 2011 dronedarone inferior to placebo in terms of HF hospitalization
in PALLAS, 2011 dronedarone inferior to placebo in terms of Cardiovascular events in PALLAS, 2011 dronedarone inferior to placebo in terms of Death, unplanned CV hospitalization in PALLAS, 2011 | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EURIDIS, 2007 | dronedarone vs placebo | Atrial fibrillation recurrence 0.78 [0.64; 0.95] Death, unplanned CV hospitalization 0.66 [0.47; 0.93] | | | | ADONIS, 2007 | dronedarone vs placebo | Atrial fibrillation recurrence 0.73 [0.60; 0.89] | | Death, unplanned CV hospitalization 0.80 [0.56; 1.14] | | DAFNE, 2003 | dronedarone vs placebo | Atrial fibrillation recurrence 0.86 [0.75; 0.98] | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia NaN [NaN; NaN] | | EURIDIS ADONIS (pooled analysis), 2009 | dronedarone vs placebo | | | all cause mortality 1.32 [0.35; 4.94] Stroke 1.98 [0.22; 17.62] Withdrawals due to adverse effects 1.36 [0.91; 2.05] | | ATHENA, 2009 | dronedarone vs placebo | cardiovascular death 0.71 [0.52; 0.97] Cardiovascular events 0.81 [0.75; 0.88] Cardiac arrhythmic death 0.55 [0.34; 0.88] hospitalization for AF 0.66 [0.59; 0.75] Atrial fibrillation recurrence 0.66 [0.59; 0.75] Death, unplanned CV hospitalization 0.81 [0.75; 0.88] | Withdrawals due to adverse effects 1.57 [1.32; 1.87] | all cause mortality 0.84 [0.66; 1.07] HF hospitalization
0.86 [0.67; 1.10] non CV death 1.09 [0.74; 1.61] Vascular noncardiac death 0.84 [0.47; 1.52] Cardiac nonarrhythmic death 0.96 [0.49; 1.85] | | ERATO, 2008 | dronedarone vs placebo | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 1.51 [0.68; 3.35] | | PALLAS, 2011 | dronedarone vs placebo | | Stroke 2.42 [1.01; 5.82] HF hospitalization
2.26 [1.24; 4.13] Cardiovascular events 2.28 [1.22; 4.25] Death, unplanned CV hospitalization 1.45 [1.10; 1.91] | all cause mortality 2.28 [0.94; 5.52] MI 1.00 [0.20; 4.93] |
| Trial | Treatments | Patients | Method |
|---|
| EURIDIS, 2007 | dronedarone 400 mg twice daily
(n=411) vs. placebo
(n=201)
| patients with at least one episode of atrial fibrillation in the preceding 3 months, and in sinus rhythm for at least 1 hour before randomization
| double blind Parallel groups Sample size: 411/201 Primary endpoint: recurrence of atrial fibrillation FU duration: 12 months
| | ADONIS, 2007 | dronedarone 400 mg twice daily (n=417) vs. placebo (n=208) | patients with at least one episode of atrial fibrillation in the preceding 3 months, and in sinus rhythm for at least 1 hour before randomization | double blind Parallel groups Sample size: 417/208 Primary endpoint: recurrence of atrial fibrillation FU duration: 12 months | | DAFNE, 2003 | Dronedarone various doses (800, 1200, 1600 mg/d) (n=151) vs. placebo (n=48) | patients with Persistent AF | double blind Parallel groups Sample size: 151/48 Primary endpoint: FU duration: | | EURIDIS ADONIS (pooled analysis), 2009 | Dronedarone 800 mg/d (n=828) vs. placebo (n=409) | AF documented in the previous 3 months | double blind Parallel groups Sample size: 828/409 Primary endpoint: First Recurrence of Atrial Fibrillation or flutter FU duration: 12 months | | ATHENA, 2009 | dronedarone 400 mg twice a day (n=2301) vs. placebo (n=2327) | patients (>70y)
with paroxysmal or persistent atrial fibrillation and additional risk factors for death | double blind Parallel groups Sample size: 2301/2327 Primary endpoint: first hospitalization due to cardiovascular events or death FU duration: 21.5 months | | ERATO, 2008 | dronedarone 400 mg twice daily (n=85) vs. placebo (n=89) | patients with permanent AF | double blind Parallel groups Sample size: 85/89 Primary endpoint: ventricular rate FU duration: 6 months | | PALLAS, 2011 | Dronedarone (n=1577) vs. placebo (n=1572) | patients with permanent atrial fibrillation and additional risk factors | double-blind Parallel groups Sample size: 1577/1572 Primary endpoint: major cardiovascular events FU duration: 3 years |
|
| atrial fibrillation | dronedarone | not classified | versus amiodarone No demonstrated result for efficacy dronedarone inferior to amiodarone in terms of Atrial fibrillation recurrence in DIONISOS, 2007 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIONISOS, 2007 | dronedarone vs amiodarone | Withdrawals due to adverse effects 0.48 [0.25; 0.90] | Atrial fibrillation recurrence 1.34 [1.17; 1.53] | all cause mortality 0.41 [0.08; 2.09] |
| Trial | Treatments | Patients | Method |
|---|
| DIONISOS, 2007 | Dronedarone (400mg BID) (n=249) vs. Amiodarone (600mg daily for 28 days, then 200mg daily thereafter) (n=255) | Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation | double blind Parallel groups Sample size: 249/255 Primary endpoint: treatment failure FU duration: 6 months |
|
| atrial fibrillation | flecainide | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Carunchio (flecainide vs placebo), 1995 | flecainide vs placebo | Atrial fibrillation recurrence 0.41 [0.20; 0.83] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects NaN [NaN; NaN] Pro-arrhythmia ∞ [NaN; ∞] | | Van Gelder, 1989 | flecainide vs no treatment | | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] Atrial fibrillation recurrence 0.81 [0.55; 1.20] |
| Trial | Treatments | Patients | Method |
|---|
| Carunchio (flecainide vs placebo), 1995 | Flecainide 200 mg/d (n=20) vs. placebo (n=26) | patients with recurrent AF with > 3 episodes in previous 1 year
| open Parallel groups Sample size: 20/26 Primary endpoint: FU duration: 12 months | | Van Gelder, 1989 | Flecainide 200-300 mg/d (n=36) vs. no treatment (n=37) | Any persistent AF or AFl | open Parallel groups Sample size: 36/37 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | flecainide | not classified | versus Class Ia No demonstrated result for efficacy flecainide inferior to quinidine in terms of Withdrawals due to adverse effects in Naccarelli, 1996 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Naccarelli, 1996 | flecainide vs quinidine | | Withdrawals due to adverse effects 1.66 [1.04; 2.65] | all cause mortality NaN [NaN; NaN] Pro-arrhythmia 1.49 [0.59; 3.78] Atrial fibrillation recurrence 1.04 [0.91; 1.19] |
| Trial | Treatments | Patients | Method |
|---|
| Naccarelli, 1996 | Flecainide 200-300 mg/d (n=117) vs. Quinidine 1-1,5 g/d (n=122) | Any documented symptomatic AF | double blind Parallel groups Sample size: 117/122 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | flecainide | not classified | versus Class Ic No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Aliot, 1996 | flecainide vs propafenone | Withdrawals due to adverse effects 0.23 [0.05; 1.00] | | all cause mortality 0.00 [0.00; NaN] Pro-arrhythmia 0.00 [0.00; NaN] Atrial fibrillation recurrence 0.75 [0.48; 1.16] |
| Trial | Treatments | Patients | Method |
|---|
| Aliot, 1996 | Flecainide 100-200mg/d (n=48) vs. Propafenone 600 mg/d (n=49) | patients with paroxysmal AF documented any time before | open Parallel groups Sample size: 48/49 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | flecainide | not classified | versus digoxin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Steinbeck (flecainide vs digoxin), 1988 | flecainide vs digoxin | Atrial fibrillation recurrence 0.46 [0.24; 0.88] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects NaN [NaN; NaN] Pro-arrhythmia 1.00 [0.07; 14.55] |
| Trial | Treatments | Patients | Method |
|---|
| Steinbeck (flecainide vs digoxin), 1988 | flecainide 200-300 mg/d (+ digoxine) (n=15) vs. (n=15)
| Paroxysmal symptomatic AF of any duration
| open Parallel groups Sample size: 15/15 Primary endpoint: FU duration: 12 months
|
|
| atrial fibrillation | metoprolol | not classified | versus placebo or control No demonstrated result for efficacy metoprolol inferior to placebo in terms of Withdrawals due to adverse effects in Kuhlkamp, 2000 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Kuhlkamp, 2000 | metoprolol vs placebo | | Withdrawals due to adverse effects 3.33 [1.37; 8.12] | all cause mortality ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] Atrial fibrillation recurrence 0.91 [0.79; 1.04] |
| Trial | Treatments | Patients | Method |
|---|
| Kuhlkamp, 2000 | Metoprolol 100 mg/d (n=197) vs. placebo (n=197) | Persistent AF lasting 2 days to 1 year | double blnd Parallel groups Sample size: 197/197 Primary endpoint: FU duration: 6 months |
|
| atrial fibrillation | propafenone | not classified | versus placebo or control No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Bellandi (propafenone vs placebo), 2001 | propafenone vs placebo | Atrial fibrillation recurrence 0.65 [0.50; 0.85] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 2.71 [0.76; 9.69] Pro-arrhythmia NaN [NaN; NaN] | | Dogan, 2004 | propafenone vs placebo | Atrial fibrillation recurrence 0.69 [0.49; 0.97] | | all cause mortality 0.00 [0.00; NaN] Withdrawals due to adverse effects 3.59 [0.41; 31.07] Pro-arrhythmia ∞ [NaN; ∞] | | Kochiadakis b (propafenone vs placebo), 2004 | propafenone vs placebo | Atrial fibrillation recurrence 0.58 [0.44; 0.78] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] | | RAFT, 2003 | propafenone vs placebo | Atrial fibrillation recurrence 0.71 [0.63; 0.79] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 1.29 [0.79; 2.11] Pro-arrhythmia NaN [NaN; NaN] | | Stroobandt, 1997 | propafenone vs placebo | | | all cause mortality 0.00 [0.00; NaN] Withdrawals due to adverse effects 1.14 [0.25; 5.12] Pro-arrhythmia 0.49 [0.09; 2.75] Atrial fibrillation recurrence 0.71 [0.50; 1.01] |
| Trial | Treatments | Patients | Method |
|---|
| Bellandi (propafenone vs placebo), 2001 | Propafenone 900 mg/d/d after pharmacological or electrical cardioversion (n=102) vs. placebo (n=92) | patients with paroxysmal recurrent or persistent AF | double blind Parallel groups Sample size: 102/92 Primary endpoint: FU duration: 12 months | | Dogan, 2004 | Propafenone 450 mg/d (n=58) vs. placebo (n=52) | AF of duration 3 hours to 3 months ??? | single Parallel groups Sample size: 58/52 Primary endpoint: FU duration: 15 months | | Kochiadakis b (propafenone vs placebo), 2004 | Propafenone 450 mg/d (n=86) vs. placebo (n=83) | Any documented symptomatic previous or persistent AF
| single Parallel groups Sample size: 86/83 Primary endpoint: FU duration: 24 months | | RAFT, 2003 | Propafenone at various doses (450, 650, 850 mg/d) (n=397) vs. placebo. (n=126) | Previous symptomatic AF documented in the last year | double blind Parallel groups Sample size: 397/126 Primary endpoint: FU duration: 9 months | | Stroobandt, 1997 | Propafenone 450 mg/d (n=77) vs. placebo (n=25) | Recent-onset AF or persistent AF lasting > 2 weeks | double blind Parallel groups Sample size: 77/25 Primary endpoint: FU duration: 6 months |
|
| atrial fibrillation | propafenone | not classified | versus Class Ia No demonstrated result for efficacy propafenone inferior to quinidine in terms of Withdrawals due to adverse effects in Richiardi, 1992 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Richiardi, 1992 | propafenone vs quinidine | | Withdrawals due to adverse effects 2.39 [1.20; 4.77] | all cause mortality 0.00 [0.00; NaN] Pro-arrhythmia 1.04 [0.15; 7.24] Atrial fibrillation recurrence 1.12 [0.87; 1.44] |
| Trial | Treatments | Patients | Method |
|---|
| Richiardi, 1992 | Propafenone 900 mg/d (n=98) vs. Quinidine 1 g/d mg/d (n=102) | Paroxysmal AF having > 3 episodes in the last 3 months | open Parallel groups Sample size: 98/102 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | propafenone | not classified | versus Class Ic No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FAPIS, 1996 | propafenone vs flecainide | | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 1.18 [0.50; 2.78] Pro-arrhythmia 2.12 [0.20; 23.05] Atrial fibrillation recurrence 1.06 [0.70; 1.62] |
| Trial | Treatments | Patients | Method |
|---|
| FAPIS, 1996 | propafenone 520 mg/dt (n=97) vs. Flecainide 200 mg/d (n=103) | Paroxysmal recurrent AF with > 2 episodes in the last 4 months | open Parallel groups Sample size: 97/103 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | propafenone | not classified | versus Class III No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Reimold, 1993 | propafenone vs sotalol | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 1.50 [0.45; 4.99] Pro-arrhythmia 1.50 [0.58; 3.90] Atrial fibrillation recurrence 0.91 [0.69; 1.20] |
| Trial | Treatments | Patients | Method |
|---|
| Reimold, 1993 | Propafenone 675 mg/d (n=50) vs. Sotalol 320 mg/d (n=50) | Any symptomatic AF or AFlx-xbitm | open Parallel groups Sample size: 50/50 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | quinidine | not classified | versus placebo or control No demonstrated result for efficacy quinidine inferior to no treatment in terms of Withdrawals due to adverse effects in Sodermark, 1975 | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hillestad, 1971 | quinidine vs no treatment | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] Atrial fibrillation recurrence 0.74 [0.48; 1.15] | | Lloyd (quinidine vs placebo), 1984 | quinidine vs placebo | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] Atrial fibrillation recurrence 0.84 [0.55; 1.28] | | PAFAC (quinidine vs placebo), 2004 | quinidine vs placebo | Atrial fibrillation recurrence 0.78 [0.69; 0.88] | | all cause mortality 1.05 [0.23; 4.78] Withdrawals due to adverse effects 1.10 [0.72; 1.68] Pro-arrhythmia 1.98 [0.47; 8.43] | | SOPAT (quinidine vs placebo), 2004 | quinidine vs placebo | Withdrawals due to adverse effects 0.74 [0.55; 1.00] Atrial fibrillation recurrence 0.89 [0.82; 0.96] | | all cause mortality ∞ [NaN; ∞] Pro-arrhythmia 1.29 [0.35; 4.83] | | Sodermark, 1975 | quinidine vs no treatment | Atrial fibrillation recurrence 0.73 [0.58; 0.92] | Withdrawals due to adverse effects 5.68 [1.78; 18.14] | all cause mortality 2.05 [0.42; 9.86] Pro-arrhythmia ∞ [NaN; ∞] | | Byrne Quinn, 1979 | quinidine vs placebo | Atrial fibrillation recurrence 0.79 [0.64; 0.97] | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 1.46 [0.67; 3.16] Pro-arrhythmia ∞ [NaN; ∞] |
| Trial | Treatments | Patients | Method |
|---|
| Hillestad, 1971 | (n=-9) vs. (n=-9) | | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | | Lloyd (quinidine vs placebo), 1984 | quinidine 1.4 g/d (n=-9) vs. placebo (n=25) | Persistent AF lasting 1 month to 3 years | double blind Parallel groups Sample size: -9/25 Primary endpoint: FU duration: 6 months | | PAFAC (quinidine vs placebo), 2004 | Quinidine 0,480 g/d (+ verapamil (n=377) vs. placebo (n=88) | Persistent AF lasting > 7 daysil | double blind Parallel groups Sample size: 377/88 Primary endpoint: FU duration: 12 months | | SOPAT (quinidine vs placebo), 2004 | Quinidine 0,320 or 0,480 g/d (+ verapamil) (n=518) vs. placebo (n=251) | Paroxysmal AF documented in the last 1 month@4 | double blind Parallel groups Sample size: 518/251 Primary endpoint: FU duration: 12 months | | Sodermark, 1975 | Quinidine 1.2 - 1.8 g/d (n=110) vs. no treatment (n=75) | Persistent AF or AFl lasting < 3 year | open Parallel groups Sample size: 110/75 Primary endpoint: FU duration: 12 months | | Byrne Quinn, 1979 | Quinidine 1.2 g/d (n=32) vs. placebo (n=42) | Persistent AF | double blind Parallel groups Sample size: 32/42 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | quinidine | not classified | versus Class Ia No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Lloyd (quinidine vs disopyramide), 1984 | quinidine vs disopyramide | | | |
| Trial | Treatments | Patients | Method |
|---|
| Lloyd (quinidine vs disopyramide), 1984 | quinidine 1.4 g/d
, quinidine 1.4 g/d
(n=28) vs. (n=29)
| Persistent AF lasting 1 month to 3 years
| double blind Parallel groups Sample size: 28/29 Primary endpoint: FU duration: 6 months
|
|
| atrial fibrillation | quinidine | not classified | versus Class Ic No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Steinbeck (quinidine vs flecainide), 1988 | quinidine vs flecainide | | | |
| Trial | Treatments | Patients | Method |
|---|
| Steinbeck (quinidine vs flecainide), 1988 | Quinidine 1 g/d (+ digoxine)
, Quinidine 1 g/d (+ digoxine)
(n=15) vs. (n=15)
| Paroxysmal symptomatic AF of any duration
| open Parallel groups Sample size: 15/15 Primary endpoint: FU duration: 12 months
|
|
| atrial fibrillation | quinidine | not classified | versus Class III No demonstrated result for efficacy quinidine inferior to sotalol in terms of Withdrawals due to adverse effects in Hohnloser, 1995 quinidine inferior to sotalol in terms of Withdrawals due to adverse effects in Juul-Moller, 1990 | 6 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hohnloser, 1995 | quinidine vs sotalol | | Withdrawals due to adverse effects 10.00 [1.38; 72.39] | all cause mortality NaN [NaN; NaN] Pro-arrhythmia 3.00 [0.33; 26.92] Atrial fibrillation recurrence 0.58 [0.28; 1.23] | | Juul-Moller, 1990 | quinidine vs sotalol | | Withdrawals due to adverse effects 2.31 [1.19; 4.47] | all cause mortality 1.15 [0.07; 18.15] Pro-arrhythmia 1.15 [0.07; 18.15] Atrial fibrillation recurrence 1.13 [0.87; 1.47] | | Kalusche, 1994 | quinidine vs sotalol | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 2.33 [0.65; 8.40] Pro-arrhythmia 0.50 [0.05; 5.30] Atrial fibrillation recurrence 0.71 [0.43; 1.18] | | SOCESP, 1999 | quinidine vs sotalol | | | all cause mortality 0.00 [0.00; NaN] Withdrawals due to adverse effects 1.32 [0.54; 3.23] Pro-arrhythmia 0.61 [0.11; 3.54] Atrial fibrillation recurrence 1.15 [0.72; 1.84] | | PAFAC (quinidine vs sotalol), 2004 | quinidine vs sotalol | | | | | SOPAT (quinidine vs sotalol), 2004 | quinidine vs sotalol | | | |
| Trial | Treatments | Patients | Method |
|---|
| Hohnloser, 1995 | Quinidine 1 g/d (n=25) vs. sotalol 240-320 mg/dt (n=25) | Persistent AF between 2 days and 6 months | open Parallel groups Sample size: 25/25 Primary endpoint: FU duration: 6 months | | Juul-Moller, 1990 | Quinidine 1,2 g/d (n=85) vs. Sotalol 160-320 mg/dt (n=98) | Persistent AF between 2 months and 1 year | open Parallel groups Sample size: 85/98 Primary endpoint: FU duration: 6 months | | Kalusche, 1994 | Quinidine 1 g/d (n=41) vs. Sotalol 240-400 mg/dt (n=41) | AF lasting from 2 weeks to 2 years | open Parallel groups Sample size: 41/41 Primary endpoint: FU duration: 12 months | | SOCESP, 1999 | Quinidine 700 mg/d (n=63) vs. sotalol 240 mg/d (n=58) | AF lasting < 6 months | open Parallel groups Sample size: 63/58 Primary endpoint: FU duration: 6 months | | PAFAC (quinidine vs sotalol), 2004 | Quinidine 0,480 g/d (+ verapamil
, Quinidine 0,480 g/d (+ verapamil
(n=377) vs. (n=383)
| Persistent AF lasting > 7 daysil
| double blind Parallel groups Sample size: 377/383 Primary endpoint: FU duration: 12 months
| | SOPAT (quinidine vs sotalol), 2004 | Quinidine 0,320 or 0,480 g/d (+ verapamil)
, Quinidine 0,320 or 0,480 g/d (+ verapamil)
(n=518) vs. (n=264)
| Paroxysmal AF documented in the last 1 month@4
| double blind Parallel groups Sample size: 518/264 Primary endpoint: FU duration: 12 months
|
|
| atrial fibrillation | quinidine | not classified | versus digoxin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Steinbeck (quinidine vs digoxin), 1988 | quinidine vs digoxin | | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia 2.00 [0.20; 19.78] Atrial fibrillation recurrence 0.77 [0.51; 1.16] |
| Trial | Treatments | Patients | Method |
|---|
| Steinbeck (quinidine vs digoxin), 1988 | Quinidine 1 g/d (+ digoxine) (n=15) vs. digoxine alone (n=15) | Paroxysmal symptomatic AF of any duration | open Parallel groups Sample size: 15/15 Primary endpoint: FU duration: 12 months |
|
| atrial fibrillation | sotalol | not classified | versus placebo or control No demonstrated result for efficacy sotalol inferior to placebo in terms of Withdrawals due to adverse effects in Benditt, 1999 | 9 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Benditt, 1999 | sotalol vs placebo | | Withdrawals due to adverse effects 9.38 [1.29; 67.87] | all cause mortality NaN [NaN; NaN] Pro-arrhythmia 1.38 [0.40; 4.78] Atrial fibrillation recurrence 0.98 [0.84; 1.14] | | Singh, 1991 | sotalol vs placebo | Atrial fibrillation recurrence 0.79 [0.64; 0.97] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] | | Bellandi (sotalol vs placebo), 2001 | sotalol vs placebo | Atrial fibrillation recurrence 0.57 [0.43; 0.76] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 2.03 [0.54; 7.61] Pro-arrhythmia ∞ [NaN; ∞] | | Carunchio (sotalol vs placebo), 1995 | sotalol vs placebo | Atrial fibrillation recurrence 0.55 [0.30; 0.98] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects NaN [NaN; NaN] Pro-arrhythmia ∞ [NaN; ∞] | | Kochiadakis (sotalol vs placebo), 2000 | sotalol vs placebo | | | | | Kochiadakis b (sotalol vs placebo), 2004 | sotalol vs placebo | Atrial fibrillation recurrence 0.72 [0.56; 0.93] | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞] | | PAFAC (sotalol vs placebo), 2004 | sotalol vs placebo | Atrial fibrillation recurrence 0.80 [0.71; 0.90] | | all cause mortality 1.49 [0.34; 6.50] Withdrawals due to adverse effects 1.10 [0.72; 1.68] Pro-arrhythmia 2.30 [0.55; 9.65] | | SAFE-T (sotalol vs placebo), 2005 | sotalol vs placebo | Atrial fibrillation recurrence 0.81 [0.73; 0.90] | | all cause mortality 2.53 [0.75; 8.58] Pro-arrhythmia 2.28 [0.50; 10.38] | | SOPAT (sotalol vs placebo), 2004 | sotalol vs placebo | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 0.88 [0.63; 1.23] Pro-arrhythmia 0.63 [0.11; 3.76] Atrial fibrillation recurrence 0.92 [0.84; 1.01] |
| Trial | Treatments | Patients | Method |
|---|
| Benditt, 1999 | Sotalol various doses (80, 120, 160 mg/d) after cardioversion (n=184) vs. placebo (n=69) | patients with AF or AFl documented in the last 3 months | double blind Parallel groups Sample size: 184/69 Primary endpoint: FU duration: 12 months | | Singh, 1991 | Sotalol 80 - 320 mg/d (n=24) vs. placebo (n=10) | Persistent AF or AFl lasting 2 weeks to 1 year | double blind Parallel groups Sample size: 24/10 Primary endpoint: FU duration: 6 months | | Bellandi (sotalol vs placebo), 2001 | sotalol 240 mg/d (n=106) vs. placebo
(n=92)
| patients with paroxysmal recurrent or persistent AF
| double blind Parallel groups Sample size: 106/92 Primary endpoint: FU duration: 12 months
| | Carunchio (sotalol vs placebo), 1995 | sotalol 240 mg/d
, (n=20) vs. placebo
(n=26)
| patients with recurrent AF with > 3 episodes in previous 1 year
| open Parallel groups Sample size: 20/26 Primary endpoint: FU duration: 12 months
| | Kochiadakis (sotalol vs placebo), 2000 | sotalol 320 mg/d (n=-9) vs. placebo
(n=-9)
| Any documented symptomatic previous or persistent AF
| single Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 24 months
| | Kochiadakis b (sotalol vs placebo), 2004 | sotalol 300 mg/d (n=85) vs. placebo
(n=83) | Any documented symptomatic previous or persistent AF
| single Parallel groups Sample size: 85/83 Primary endpoint: FU duration: 24 months
| | PAFAC (sotalol vs placebo), 2004 | sotalol 320 mg/d , (n=383) vs. placebo
(n=88)
| Persistent AF lasting > 7 daysil
| double blind Parallel groups Sample size: 383/88 Primary endpoint: FU duration: 12 months
| | SAFE-T (sotalol vs placebo), 2005 | sotalol 320 mg/d (n=261) vs. placebo
(n=132)
| Persistent AF lasting 3 days to 1 year
| double blind Parallel groups Sample size: 261/132 Primary endpoint: FU duration: 12 months
| | SOPAT (sotalol vs placebo), 2004 | sotalol 320 mg/d , (n=264) vs. placebo
(n=251)
| Paroxysmal AF documented in the last 1 month@4
| double blind Parallel groups Sample size: 264/251 Primary endpoint: FU duration: 12 months
|
|
| atrial fibrillation | sotalol | not classified | versus Class Ic No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Carunchio (sotalol vs flecianide), 1995 | sotalol vs flecainide | | | | | Kochiadakis b (sotalol vs propafenome), 2004 | sotalol vs propafenone | | | |
| Trial | Treatments | Patients | Method |
|---|
| Carunchio (sotalol vs flecianide), 1995 | sotalol 240 mg/d
,
, sotalol 240 mg/d
,
(n=20) vs. (n=20)
| patients with recurrent AF with > 3 episodes in previous 1 year
| open Parallel groups Sample size: 20/20 Primary endpoint: FU duration: 12 months
| | Kochiadakis b (sotalol vs propafenome), 2004 | sotalol 300 mg/d
,
, sotalol 300 mg/d
,
(n=85) vs. (n=86)
| Any documented symptomatic previous or persistent AF
| single Parallel groups Sample size: 85/86 Primary endpoint: FU duration: 24 months
|
|
| atrial fibrillation | sotalol | not classified | versus Class II No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Plewan, 2001 | sotalol vs bisoprolol | | | all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects 1.33 [0.31; 5.72] Pro-arrhythmia 1.33 [0.31; 5.72] Atrial fibrillation recurrence 1.07 [0.74; 1.55] |
| Trial | Treatments | Patients | Method |
|---|
| Plewan, 2001 | Sotalol 160 mg/d (n=64) vs. bisoprolol 5 mg/d (n=64) | Persistent AF | open Parallel groups Sample size: 64/64 Primary endpoint: FU duration: 8 months |
|
| cardiac arrest | amiodarone | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ARREST, 1999 | amiodarone vs placebo | survival to hospital admission 1.60 [1.08; 2.37] | | |
| Trial | Treatments | Patients | Method |
|---|
| ARREST, 1999 | intravenous amiodarone 300mg (n=246) vs. placebo (n=258) | Patients with cardiac arrest by ventricular fibrillation (or pulseless ventricular tachycardia) and not resuscitated after receiving three or more precordial shocks | double blind Sample size: 246/258 Primary endpoint: admission to the hospital FU duration: |
|
| cardiac arrest | amiodarone | not classified | versus lidocaine No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ALIVE, 2002 | amiodarone vs lidocaine | survival to hospital admission 1.90 [1.16; 3.11] death before hospital admission 0.88 [0.80; 0.97] | | death 0.98 [0.94; 1.02] |
| Trial | Treatments | Patients | Method |
|---|
| ALIVE, 2002 | intravenous amiodarone plus lidocaine placebo (n=180) vs. intravenous lidocaine plus amiodarone placebo (n=167) | out-of-hospital ventricular fibrillation resistant to three shocks, intravenous epinephrine, and a further shock; or recurrent ventricular fibrillation after initially successful defibrillation | double blind Sample size: 180/167 Primary endpoint: admitted alive to hospital FU duration: 1 day |
|
| heart failure | amiodarone | not classified | versus placebo or control No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Hamer, 1989 | amiodarone vs placebo | Arrhythmic/sudden death 0.09 [0.01; 0.72] | | All cause death 0.75 [0.24; 2.31] | | Nicklas, 1991 | amiodarone vs placebo | | | All cause death 1.54 [0.59; 4.02] Arrhythmic/sudden death 1.93 [0.67; 5.55] | | EPAMSA, 1985 | amiodarone vs no treatment | All cause death 0.39 [0.15; 1.00] | | Arrhythmic/sudden death 0.39 [0.12; 1.24] | | GESICA, 1994 | amiodarone vs no treatment | All cause death 0.72 [0.55; 0.95] | | Arrhythmic/sudden death 0.72 [0.45; 1.16] | | STATCHF, 1995 | amiodarone vs placebo | | | All cause death 0.94 [0.71; 1.24] Arrhythmic/sudden death 0.84 [0.57; 1.24] |
| Trial | Treatments | Patients | Method |
|---|
| Hamer, 1989 | amiodarone 200 mg/day (n=34) vs. placebo (n=0) | patients with severe congestive heart failure but no sustained ventricular arrhythmia | double blind Sample size: 34/0 Primary endpoint: LVEF FU duration: 1·63 years | | Nicklas, 1991 | amiodarone 200 mg/day (n=101) vs. placebo (n=0) | patients with ejection fractions less than 30%, New York Heart Association class III or IV symptoms, and frequent but asymptomatic spontaneous ventricular ectopy (Lown class II to V) LVEF <=30% and Lown class 2–5 | double blind Sample size: 101/0 Primary endpoint: FU duration: NA | | EPAMSA, 1985 | amiodarone 400 mg/day (n=66) vs. no treatment (n=61) | patients with reduced left ventricular ejection fraction ( < 35%) and asymptomatic ventricular arrhythmias (Lown classes 2 and 4) LVEF <=35% and Lown class 2–5 | open Sample size: 66/61 Primary endpoint: FU duration: 0·81 years | | GESICA, 1994 | amiodarone 300 mg/day (n=260) vs. no treatment (n=256) | patients with severe heart failure Any two of CTR >0·55, LVEF<=35%, echo LVED >3·2 cm/m2 | open Sample size: 260/256 Primary endpoint: FU duration: 1·10 years | | STATCHF, 1995 | amiodarone 200 mg/day (n=674) vs. placebo (n=0) | patients with symptoms of congestive heart failure, cardiac enlargement, 10 or more premature ventricular contractions per hour, and a left ventricular ejection fraction of 40 percent or less LVEF <=40% and >=10 VPD/h and LVED >=55 mm or CTR >0·55 | double blind Sample size: 674/0 Primary endpoint: overall mortality FU duration: 2·15 years |
|
| heart failure | amiodarone | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| AMIOVIRT, 2003 | amiodarone vs ICD | | | All cause death 1.14 [0.41; 3.17] Arrhythmic/sudden death 1.96 [0.18; 20.97] |
| Trial | Treatments | Patients | Method |
|---|
| AMIOVIRT, 2003 | amiodarones (n=52) vs. implantable cardioverter-defibrillatorag (n=51) | patients with
nonischemic dilated cardiomyopathy, asymptomatic nonsustained ventricular tachycardia, and left ventricular ejection fraction <=0.35 | Parallel groups Sample size: 52/51 Primary endpoint: total mortality FU duration: 2 y |
|
| heart failure | dronedarone | not classified | versus placebo or control No demonstrated result for efficacy dronedarone inferior to placebo in terms of All cause death in ANDROMEDA, 2008 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ANDROMEDA, 2008 | dronedarone vs placebo | | All cause death 2.13 [1.09; 4.16] | death from any cause or hospitalization 1.35 [0.93; 1.98] Arrhythmic/sudden death 1.70 [0.63; 4.63] |
| Trial | Treatments | Patients | Method |
|---|
| ANDROMEDA, 2008 | dronedarone 400mg twice daily (n=310) vs. placebo (n=317) | patients hospitalized with symptomatic heart failure and severe left ventricular systolic dysfunction | double blind Parallel groups Sample size: 310/317 Primary endpoint: death, hospitalization for HF FU duration: median 2 months |
|
| post myocardial infarction | amiodarone | not classified | versus placebo or control No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BASIS, 1990 | early amiodarone vs control | Total mortality 0.41 [0.17; 0.99] | | Arrhythmic/sudden death 0.52 [0.18; 1.52] | | CAMIAT , 1991 | early amiodarone vs placebo | | | Total mortality 0.82 [0.58; 1.15] Arrhythmic/sudden death 0.71 [0.42; 1.19] | | Ceremuzynski, 1992 | early amiodarone vs placebo | | | Total mortality 0.63 [0.38; 1.06] Arrhythmic/sudden death 0.51 [0.25; 1.03] | | Navarro-Lopez, 1993 | early amiodarone vs control | | | Total mortality 0.48 [0.16; 1.43] Arrhythmic/sudden death 0.63 [0.16; 2.48] | | Hockings, 1987 | early amiodarone vs placebo | | | Total mortality 1.94 [0.84; 4.46] Arrhythmic/sudden death 1.64 [0.36; 7.49] |
| Trial | Treatments | Patients | Method |
|---|
| BASIS, 1990 | amiodarone 1 g for 5 d; then 200 mg/d started within 4 weeks of AMI (n=98) vs. no amiodarone (usual care) (n=14) | patients with persisting asymptomatic complex arrhythmias after myocardial infarction (Lown class 3 or 4b in > 2 of 24 h) | open Parallel groups Sample size: 98/14 Primary endpoint: total mortality and arrhythmic events FU duration: 12 mo | | CAMIAT , 1991 | amiodarone 10 mg/kg per d for 3 weeks then 300-400 mg/d started 6-45 d after AMI (n=-9) vs. placebo (n=-9) | patients with acute myocardial infarction within the previous 6-30 days and > 10 VPDs/h for 18 h or a run of VT | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 24 mo | | Ceremuzynski, 1992 | amiodarone 800 mg/d for 1 week then 200-400 mg/d started 5-7 d after AMI (n=305) vs. placebo (n=308) | No need for antiarrhythmic therapy | double blind Parallel groups Sample size: 305/308 Primary endpoint: FU duration: 12 mo | | Navarro-Lopez, 1993 | amiodarone 600 mg/d for 1 week, 400 mg/d for 1 week then 200 mg/d started 10-30 d after AMI (n=115) vs. no amiodarone (n=123) | patients who have had MI with a left ventricular ejection fraction of 20 to 45% and > or = 3 ventricular premature complexes per hour (pairs or runs) - 3 VPOs/h, pairs or runs of VT | open Parallel groups Sample size: 115/123 Primary endpoint: FU duration: 24 mo | | Hockings, 1987 | amiodarone 200 mg 3 times daily for 1 wk; then 200 mg/d started < 8-10 d after AMI (n=59) vs. placebo (n=70) | patients with AMI - Absence of VF or VT > 3 beats | double blind Parallel groups Sample size: 59/70 Primary endpoint: FU duration: 6·42 mo |
|
| post myocardial infarction | Azimilide | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ALIVE, 2004 | azimilide vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| ALIVE, 2004 | azimilide 100 mg (n=-9) vs. placebo (n=-9) | post-MI patients with depressed LVF | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 1y |
|
| post myocardial infarction | dofetilide | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIAMOND MI, 1997 | dofetilide vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| DIAMOND MI, 1997 | dofetilide (n=-9) vs. placebo (n=-9) | patients with acute myocardial infarction within 7 days and left ventricular systolic dysfunction (EF <= 35%) | double blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: >12 months |
|
| post myocardial infarction | moricizine | not classified | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| CAST II (early treatment), 1992 | moricizine vs placebo | | | | | CAST II (late treatment), 1992 | moricizine vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| CAST II (early treatment), 1992 | moricizine for 14 days (n=665) vs. placebo (n=660) | acute myocardial infarction | double blind Parallel groups Sample size: 665/660 Primary endpoint: mortality FU duration: 14 days | | CAST II (late treatment), 1992 | long term moricizine (n=1155) vs. placebo (n=0)
| patient survivor to a myocardial infarctionwhose ventricular premature depolarizations were adequately suppressed by moricizine
| double blind Parallel groups Sample size: 1155/0 Primary endpoint: mortality FU duration:
|
|
