Meta‐analysis of the Risk of Torsades de Pointes in Patients Treated with Intravenous Racemic Sotalol

Abstract

Abstract. 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.

Intravenous Sotalol: An Under Used Treatment Strategy

“…The general impression has been that rapid IV loading increases the risk for pro-arrhythmic toxicity, and thus, IV sotalol is to be avoided. Data contrary to this widely held belief comes from a large metaanalysis that included 37 published reports with 962 patients receiving IV sotalol [10]. Marill and Runge [10] found that "overall risk of Torsade de Pointes in patients treated with a single infusion of IV sotalol is low (0.1%) compared with that in patients given chronic oral sotalol therapy," lower than the 2-4% pro-arrhythmic incidence seen with oral therapy.…”

“…Data contrary to this widely held belief comes from a large metaanalysis that included 37 published reports with 962 patients receiving IV sotalol [10]. Marill and Runge [10] found that "overall risk of Torsade de Pointes in patients treated with a single infusion of IV sotalol is low (0.1%) compared with that in patients given chronic oral sotalol therapy," lower than the 2-4% pro-arrhythmic incidence seen with oral therapy. The authors employed a much faster infusion of 1.5 mg/kg, or 100 mg sotalol over 30 min than what is recommended in the IV sotalol product label.…”

Management of Atrial Fibrillation Post Bypass Surgery with Intravenous Sotalol: A Case Study

“…This is primarily due to its effect on QTc prolongation. Conversely, in a meta-analysis studying 962 patients receiving IV sotalol, the risk of Torsades de Pointes with IV sotalol was 0.1%, significantly lower than with oral sotalol [14] . Piccini et al did discuss that although the all-cause mortality of patients receiving sotalol was greater compared to patients receiving no antiarrhythmic drug therapy, there was a significantly decreased mortality compared to amiodarone (hazard ratio 0.72, 95% CI: 0.55 -0.91, p = 0.0141) [7] .…”

Intravenous Sotalol - Reintroducing a Forgotten Agent to the Electrophysiology Therapeutic Arsenal

“…The incidence is lower in comparison to amiodarone and similar in groups randomized to lidocaine or sotalol. [1], [17], [20] Bradycardia, AV block and heart failure are also reported, especially in patients with low ejection fraction. Non-cardiac adverse effects from intravenous sotalol include nonspecific gastrointestinal or neurological (headache, dizziness, malaise) complaints but the incidence is significantly lower than amiodarone.…”

“…Alternative explanations for this low incidence of TdP in this study include administration during tachycardia in the acute setting and resultant shortened QT, possible reverse use-dependence, and heterogeneity in dosing and infusion duration. [17] Hypotension is the most commonly reported side effect after intravenous sotalol, particularly when given in the early post-cardiac surgery setting. It is also of clinical significance in patients with VT with or without concomitant use of lidocaine.…”