Effect of Amiodarone in Mortality in Patients with Severe Heart Failure

pp 207-211

Abstract

Background

Low-dose amiodarone therapy in patients with severe heart failure was based on the hypothesis that the decrease in total mortality would be possible through a reduction of arrhythmic or sudden death.

Material and method

GESICA trial evaluated the effect of low-dose amiodarone over two-year mortality in patients with severe heart failure and it was carried out as a prospective multicentric randomized open study, including 516patients, 260 amiodarone (group A) versus 256 control(group X). Amiodarone patients received 600 mg daily during 14 days and then, 300 mg daily over the rest of the study.ResultsIntention to treat analysis after a two-year follow-up showed a risk reduction 28% (95% CI, 4-45), log-rank test p < 0.012; Cox regression model, risk reduction 31% (95% CI, 9-48; p < 0.005). In group A 119/260 patients died or were hospitalized due to worsening of heart failure, as compared to 149/256 from the group C risk reduction 31% (95% CI of 13% to 46%); log-rank test p < 0.0012. Amiodarone related side-effects were reported in 17 patients(6.1%).In 12 patients (4.6%) amiodarone administration was interrupted. The cause of the interruption was: symptomatic sinus bradycardia in 8 patients, complete auriculo ventricular block in 1, nodal rhythm in 1, and gastric intolerance in 2. Sudden deaths, risk reduction27%(95% CI, 17 to 54%i.; p <0.08)and progressive heart failure deaths risk reduction 23% (95% CI of 15% to 48%; p<0.08). The difference between survival curves started after 30 days when considering sudden death and beyond 120 days with progressive heart failure death. The decrease in mortality and/or hospitalization was present in all subgroups examined, and it was independent of the presence of non-sustained ventricular tachycardia on the admission Holter.

Conclusions

Low-dose amiodarone proved to be an effective and reliable therapy reducing mortality and hospitalization in patients with severe heart failure, independently of the presence of complex ventricular arrhythmias.