Meta-Analysis Comparing the Relative Risk of Adverse Events for Amiodarone Versus Placebo

Abstract

Amiodarone has been associated with adverse events that may restrict its use. We performed a meta-analysis of placebo-controlled trials to assess the relative risk of adverse events of amiodarone compared with placebo. In total, 43 randomized trials were included. A total of 11,395 patients were included (5,792 patients randomized to amiodarone and 5,603 patients randomized to placebo). The incident rate of adverse events per 10,000 person-years was higher in the amiodarone group compared with placebo for pulmonary (129 vs 74; relative risk (RR) 1.77, p = 0.002), thyroid (201 vs 42; RR 4.44, p <0.001), hepatic (54 vs 25; RR 2.27, p = 0.01), cardiac (771 vs 450; RR 1.94, p <0.001), neurological (140 vs 76; RR 1.93, p <0.001), and skin (81 vs 23; RR 1.99, p = 0.04) adverse events. Low-dose amiodarone was not associated with statistically significant increase in pulmonary adverse events but was still associated with thyroid and liver adverse events. In conclusion, the likelihood of experiencing adverse events related to amiodarone was higher than that of placebo. The overall rate of adverse events however, was low, and severe adverse events were rare.