Effect of amiodarone therapy on mortality in patients with left ventricular dysfunction and asymptomatic complex ventricular arrhythmias: Argentine Pilot Study of Sudden Death and Amiodarone (EPAMSA).
The efficiency of prophylactic antiarrhythmic treatment with amiodarone in reducing 1-year mortality in patients with reduced left ventricular ejection fraction ( < 35%) and asymptomatic ventricular arrhythmias (Lown classes 2 and 4) was investigated in a prospective, multicenter, randomized, controlled study. Among 127 patients who entered the study, 61 were assigned to no antiarrhythmic therapy (control group [CG] and 66 to amiodarone treatment (amiodarone group [AG]). Amiodarone was administered at a dosage of 800 mg/day for 2 weeks followed by 400 mg/day thereafter. A 12-month follow-up was completed for 106 patients (57 in the AG and 49 in the CG). Amiodarone reduced the overall mortality rate, which was 10.5% in the AG versus 28.6% in the CG (odds ratio [OR] 0.29; 95% confidence interval [CI] 0.10 to 0.84; log-rank test 0.02) and sudden death rate, which was 7.0% in the AG versus 20.4% in the CG (OR 0.29; 95% CI 0.08 to 1.00; log-rank test 0.04). Side effects were rare, and in only three patients did amiodarone treatment have to be discontinued.
Garguichevich
J J
JJ
Committee on Arrhythmia, Federación Argentina de Cardiología, Rosario.
Ramos
J L
JL
Gambarte
A
A
Gentile
A
A
Hauad
S
S
Scapin
O
O
Sirena
J
J
Tibaldi
M
M
Toplikar
J
J
D000368:Aged; D000638:Amiodarone / Q000627:therapeutic use*; D001118:Argentina / Q000453:epidemiology; D016757:Death, Sudden, Cardiac / Q000453:epidemiology* / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013223:Statistics as Topic; D017180:Tachycardia, Ventricular / Q000188:drug therapy* / Q000401:mortality*; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000401:mortality*; D014693:Ventricular Fibrillation / Q000188:drug therapy* / Q000401:mortality*
D000638:Amiodarone