Safety of amiodarone in the prevention of postoperative atrial fibrillation: a meta-analysis.

OBJECTIVE

A meta-analysis was conducted to assess the safety of amiodarone in the prevention of postoperative atrial fibrillation.

METHODS

A search of the medical literature was conducted to identify randomized controlled trials of prophylactic amiodarone use in cardiothoracic surgery. Studies were independently reviewed by three investigators and selected for inclusion if they met the following three criteria: (1) randomized controlled trial of amiodarone versus placebo or routine treatment, (2) patients underwent coronary artery bypass graft or valvular surgery, and (3) reported data on the frequency of at least one of the following safety endpoints: bradycardia, hypotension, heart block, nausea, cerebral vascular accident, myocardial infarction, and death. Both random- and fixed-effects models were used to determine any significant associations between amiodarone and safety endpoints.

RESULTS

Eighteen trials were analyzed. A total of 3408 patients were enrolled in these trials (1736 received amiodarone and 1672 received placebo). Amiodarone increased the odds of developing bradycardia (odds ratio [OR], 1.70; 95% confidence interval [CI], 1.05-2.74) and hypotension (OR, 1.62; 95% CI, 1.04-2.54). The administration of i.v. amiodarone, an average daily dose exceeding 1 g, and postoperative amiodarone administration were each associated with a greater likelihood of hemodynamic adverse effects. Amiodarone did not appear to affect other safety endpoints.

CONCLUSIONS

Meta-analysis showed amiodarone to be associated with an increased risk of developing bradycardia and hypotension when used for the prophylaxis of postoperative atrial fibrillation. The greatest risk in the occurrence of these adverse events arose when using regimens containing i.v. amiodarone, initiating prophylaxis during the postoperative period, and using regimens with average daily doses exceeding 1 g.