Effects of Early Administration of Amiodarone on Mortality in Acute Myorcardial Infarction. Results of the GEMICA Study

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Abstract

Background

Previous clinical studies with amiodarone have shown a significant prognosis improvement on cardiac mortality after myocardial infarction. However, no studies have assessed the effects of amiodarone on mortality when the drug is administered in the early stages after the coronary occlusion.

Material and method

The GEMICA trial was designed as a prospective, multicenter double blind randomized study to assess whether intravenous and oral administration of amiodarone added to the current therapy and given in the early hours of the onset, will improve the short and long term outcome of patients undergoing an acute myocardial infarction, compared with the conventional therapeutical strategies. The main aim of the study was to evaluate the efficacy and safety of amiodarone on mortality reduction during a 6-months period in those patients with acute myocardial infarction with less than 24 hours of evolution, without age limits and functional class Killip-Kimball A and B, admitted in the coronary care units participating in the trial. Initially, the amiodarone/placebo dose was 1350 mg intravenous per day, during two days together with 1200 mg orally during four days followed by 400 mg/day during three months and thereafter 200 mg/day up to the end of the study (180 days). After the inclusion of 516 patients this protocol was changed as follows: 600 mg intravenous/day, two days and800 mg/day orally two days and from the non 400mg/day during three months and 200 mg/day until the end of the study.ResultsOf the 1073 patients included in the study, 539 received amiodarone and 534 placebo. Overall mortality was 10.72%,11.69% in the amiodarone group and 9.74% in the placebo group (p = NS). Patients receiving amiodarone showed a lower trend to have arrhythmic events. However, none of these variables were statistically significant when compared with the placebo group.

Conclusions

The findings of this study have shown that amiodarone does not reduce, at short or long term, mortality or the incidence of main cardiac events in patients with myocardial infarction.