Morbidity and mortality following early administration of amiodarone in acute myocardial infarction. GEMICA study investigators, GEMA Group, Buenos Aires, Argentina. Grupo de Estudios Multicéntricos en Argentina.

AIMS: The objective of this study was to ascertain the effect of intravenous and oral amiodarone on morbidity and mortality in patients during the first hours after the onset of an acute myocardial infarction. METHODS AND RESULTS: A cohort of 1073 patients admitted to the CCU within 24 h of the onset of symptoms of an acute myocardial infarction and heart failure (Killip and Kimball A-B) were randomized to receive amiodarone (n=542) or placebo (n=531) for 6 months. Because of the higher mortality, on an interim analysis, from a 'high dose' of amiodarone or placebo (516 patients) the protocol was changed to a 'low dose' or placebo (557 patients). Mortality with high doses of amiodarone was 16.30% vs 10.16% in the placebo group (P=0.04), whereas mortality with low doses was 6.61% vs 9.47% in the control group (P=0.20). Several non-fatal adverse effects were observed in 108 and 73 patients treated with amiodarone and placebo, respectively. CONCLUSION: This study demonstrated that early administration of amiodarone in low doses to patients with an acute myocardial infarction may be used only if life-threatening arrhythmia justify its prescription. Conversely, when given in high doses, it might increase mortality.

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.