Sotalol Hydrochloride Tablets have been studied in life-threatening and less severe arrhythmias. In patients with frequent premature ventricular complexes (VPC), Sotalol Hydrochloride Tablets were significantly superior to placebo in reducing VPCs, paired VPCs and non-sustained ventricular tachycardia (NSVT); the response was dose-related through 640 mg/day with 80–85% of patients having at least a 75% reduction of VPCs. Sotalol Hydrochloride Tablets were also superior, at the doses evaluated, to propranolol (40–80 mg TID) and similar to quinidine (200–400 mg QID) in reducing VPCs. In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], Sotalol Hydrochloride Tablets were studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically.

In a double-blind, randomized comparison of Sotalol Hydrochloride Tablets and procainamide given intravenously (total of 2 mg/kg Sotalol Hydrochloride vs. 19 mg/kg of procainamide over 90 minutes), Sotalol Hydrochloride Tablets suppressed PES induction in 30% of patients vs. 20% for procainamide (p=0.2).

In a randomized clinical trial [Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial] comparing choice of antiarrhythmic therapy by PES suppression vs. Holter monitor selection (in each case followed by treadmill exercise testing) in patients with a history of sustained VT/VF who were also inducible by PES, the effectiveness acutely and chronically of Sotalol Hydrochloride Tablets was compared with that of 6 other drugs (procainamide, quinidine, mexiletine, propafenone, imipramine and pirmenol). Overall response, limited to first randomized drug, was 39% for Sotalol Hydrochloride Tablets and 30% for the pooled other drugs. Acute response rate for first drug randomized using suppression of PES induction was 36% for Sotalol Hydrochloride Tablets vs. a mean of 13% for the other drugs. Using the Holter monitoring endpoint (complete suppression of sustained VT, 90% suppression of NSVT, 80% suppression of VPC pairs, and at least 70% suppression of VPCs), Sotalol Hydrochloride Tablets yielded 41% response vs. 45% for the other drugs combined. Among responders placed on long-term therapy identified acutely as effective (by either PES or Holter), Sotalol Hydrochloride Tablets, when compared to the pool of other drugs, had the lowest two- year mortality (13% vs. 22%), the lowest two-year VT recurrence rate (30% vs. 60%), and the lowest withdrawal rate (38% vs. about 75–80%). The most commonly used doses of Sotalol Hydrochloride Tablets in this trial were 320– 480 mg/day (66% of patients), with 16% receiving 240 mg/day or less and 18% receiving 640 mg or more.

It cannot be determined, however, in the absence of a controlled comparison of Sotalol Hydrochloride Tablets vs. no pharmacologic treatment (for example, in patients with implanted defibrillators) whether Sotalol Hydrochloride Tablets response causes improved survival or identifies a population with a good prognosis.

Sotalol Hydrochloride Tablets have not been shown to enhance survival in patients with ventricular arrhythmias.