Abstract 3236: Safety and Efficacy of Sotalol Therapy in Cardiac Patients. A Meta-Analysis of Randomized Control Trials
Background Sotalol, a class III antiarrhytmic drug used for suppressing of atrial and ventricular tachyarrhythmias, is known to trigger proarrhythmic events like Torsades de Points tachycardia (TdP) or ventricular fibrillation (VF). Although several randomized trials assessing the efficacy and safety of sotalol have been published, a precise analysis of mortality or severe arrhythmic effects is still lacking. The present meta-analysis investigates safety of sotalol compared with other antiarrhythmic agents or placebo in cardiac patients.
Methods Data sources were PubMed and the Cochrane Central Register of controlled Trials. Only randomised clinical trials comparing the safety of sotalol with other antiarrhythmic agents (amiodarone, propafenone, verapamil, quinidin, digoxin, betablocker) or placebo and reporting the outcomes of interrest (TdP, other ventricular tachycardia [VT], VF, death) during the follow-up of at least 1 week were selected.
Results Fourty trials, including 8911 patients (4063 sotalol), met the selection criteria. No significant heterogenity was found across trials. The primary endpoint, a composite of TdP, VT, VF or death, was not different in all patients treated with sotalol vs other antiarrhythmic drugs (sotalol: TdP 13, VT 52, VF 5, death 127; other antiarrhythmic drugs: TdP 4, VT 52, VF 5, death 114; OR, 1.1; 95% CI, 0.85–1.56; P=0.367). Furthermore, there was also no difference in patients with coronary heart disease, heart failure or ventricular tachykardia. However, patients assigned to sotalol because of atrial fibrillation (AF) had higher rate of life threatening tachycardias and mortality (sotalol: TdP 12, VT 13, VF 5, death 37; other antiarrhythmic drugs: TdP 1, VT 16, VF 5, death 33; OR, 1.59; 95% CI, 1.02–2.48; P=0.039). Similarly, the primary endpoint was also more frequently observed in the sotalol group than in AF patients with placebo or betablocker (sotalol: TdP 12, other VT 10, VF 3, death 31; betablocker or placebo: no proarrhythmic events, death 12; OR, 2.51; 95% CI, 1.29 – 4.91; P=0.007).
Conclusion Although Sotalol is an effective drug for suppressing rhythm disorders, in patients with AF it is associated with increased incidence of life threatening tachycardias and mortality.