| pathology | Demonstrated benefit and harm | k | | | |
|---|
| atrial fibrillation | 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 | 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 | 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 | 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 | 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
|
|
| cardiac arrest | 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 | 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 | 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 | 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 |
|
| post myocardial infarction | 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 |
|
