Clinical trials of amiodarone - TrialResults-center.org

Aratac - Tachydaron - Rytmarone - Ortacrone - Corbionax - Braxan - Amiohexal - Amiodarona - Trangorex - Kordaron - Amiodarex - Cordarex - Cordarone - Amiobeta

pathology

Benefit (demonstrated or suggested) and harm

atrial fibrillation

All results are NS for efficacy

inferior to sotalol in terms of Withdrawals due to adverse effects in Kochiadakis a, 2004

meta-analysis

Trial	control	p<0.05	harm	NS
AFFIRM Substudy (amiodarone vs sotalol), 2003	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]
Channer, 2004	vs sotalol	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	vs sotalol	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	vs sotalol	Atrial fibrillation recurrence 0.53 [0.39; 0.73]		all cause mortality NaN [NaN; NaN] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia ∞ [NaN; ∞]
Kochiadakis a, 2004	vs sotalol		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]
SAFE-T (amiodarone vs placebo), 2005	vs sotalol	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]
Villani, 1992	vs sotalol	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	vs sotalol	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]
AFFIRM Substudy (amiodarone vs class I drugs), 2003	vs sotalol	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]
Kochiadakis (amiodarone vs sotalol), 2000	vs sotalol
SAFE-T (amiodarone vs sotalol), 2005	vs sotalol
AFFIRM Substudy (sotalol vs class I drugs), 2003	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
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
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
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
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
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
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
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

cardiac arrest

All results are NS for efficacy

meta-analysis

heart failure

All results are NS for efficacy

meta-analysis

Trial	control	p<0.05	NS
Hamer, 1989	vs placebo	Arrhythmic/sudden death 0.09 [0.01; 0.72]	All cause death 0.75 [0.24; 2.31]
Nicklas, 1991	vs placebo		All cause death 1.54 [0.59; 4.02] Arrhythmic/sudden death 1.93 [0.67; 5.55]
EPAMSA, 1985	vs placebo	All cause death 0.39 [0.15; 1.00]	Arrhythmic/sudden death 0.39 [0.12; 1.24]
GESICA, 1994	vs placebo	All cause death 0.72 [0.55; 0.95]	Arrhythmic/sudden death 0.72 [0.45; 1.16]
STATCHF, 1995	vs placebo		All cause death 0.94 [0.71; 1.24] Arrhythmic/sudden death 0.84 [0.57; 1.24]
AMIOVIRT, 2003	vs placebo		All cause death 1.14 [0.41; 3.17] Arrhythmic/sudden death 1.96 [0.18; 20.97]

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
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

All results are NS for efficacy

meta-analysis

Trial	control	p<0.05	NS
BASIS, 1990	vs control	Total mortality 0.41 [0.17; 0.99]	Arrhythmic/sudden death 0.52 [0.18; 1.52]
CAMIAT , 1991	vs control		Total mortality 0.82 [0.58; 1.15] Arrhythmic/sudden death 0.71 [0.42; 1.19]
Ceremuzynski, 1992	vs control		Total mortality 0.63 [0.38; 1.06] Arrhythmic/sudden death 0.51 [0.25; 1.03]
Navarro-Lopez, 1993	vs control		Total mortality 0.48 [0.16; 1.43] Arrhythmic/sudden death 0.63 [0.16; 2.48]
Hockings, 1987	vs control		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

Amiodarone antiarrythmic drugs Description Results

Group by...

Amiodarone antiarrythmic drugs
Description Results