Meta-analysis of the Risk of Torsades de Pointes in patients treated with intravenous racemic sotalol.

OBJECTIVE

Intravenous (IV) racemic sotalol is useful for the treatment of multiple tachydysrhythmias. The authors hypothesized that the risk of torsades de pointes (TdP) in patients treated with a single IV infusion of sotalol is lower than the 2-4% risk associated with chronic oral sotalol therapy.

METHODS

A MEDLINE search under the subject heading "sotalol" was made of all publications involving humans written in English or German from 1966 to October 1, 2000. A meta-analysis of all original reports including patients who were given a single infusion of at least 1.5 mg/kg or 100 mg of IV sotalol over 30 minutes or less was performed. Potential variables predictive of TdP were assessed. The primary outcome was the observation of TdP associated with IV sotalol infusion. Secondary measurements included hypotension, bradycardia, and worsening of congestive heart failure. All excluded studies and case reports were also examined for evidence of TdP associated with IV sotalol treatment.

RESULTS

The search included 1,005 publications. There were 37 reports in which 962 patients received IV sotalol and met the inclusion criteria. There was one report of self-terminating TdP lasting 10 seconds among the 962 patients included in the study. There was no report of TdP associated with only IV racemic sotalol administration in any of the excluded studies. If it is assumed that the risk of TdP is homogeneous in the population of patients treated with IV sotalol, then based on the 962 included patients, the rate of TdP is 0.1% (95% CI = 0.003% to 0.6%).

CONCLUSIONS

The overall risk of TdP in patients treated with a single infusion of IV sotalol is low compared with that in patients given chronic oral sotalol therapy.