Safety Of Sotalol Research Articles

Sotalol prophylaxis was efficient and safe for supraventricular tachycardia in early infancy.

There is no consensus on the best prophylaxis for supraventricular tachycardia (SVT) in infancy. We studied the efficacy and safety of sotalol. This retrospective study comprised infants diagnosed with SVT before 1 year of age and treated with sotalol during 2002-2018 in Stockholm, Sweden. The patients' characteristics, comorbidities, sotalol dosages, QT intervals and outcomes were extracted from their medical records. We studied 85 infants (65% boys) with a median age of eight (range 0-288) days at the time of diagnosis, including 78 with re-entry tachycardia. Sotalol was completely or partially successful in the 67/75 patients who completed the treatment, as well as in four of the seven patients with other tachycardia mechanisms. The 48 infants with postnatal debut had significantly higher success rates than the 27 with foetal debut (96% vs. 78%, p = 0.04). Prolongation of corrected QT (QTc) intervals of ≥450 ms occurred in 16% of the total cohort and two patients with QTc intervals of ≥500 ms had their treatment changed. There were no cases of proarrhythmia after sotalol treatment. Sotalol provided effective and safe prophylaxis for SVT during infancy. QTc prolongation rarely caused treatment discontinuation and there were no cases of proarrhythmia.

Efficacy and Safety of Sotalol in Children With Arrhythmia

Efficacy and Safety of Sotalol in Children With Arrhythmia

Efficacy and adverse effects of sotalol in adults with congenital heart disease

IntroductionAdults with congenital heart disease (CHD) are predisposed to arrhythmias, which can often be refractory to medical therapy. Sotalol is an attractive alternative antiarrhythmic to amiodarone in this younger patient population, given the latter's toxicity profile, but it may have proarrhythmic effects. We therefore aimed to assess the efficacy and safety of sotalol in adults with CHD. MethodsWe retrospectively assessed our adult CHD database for all patients ≥16 years old, with moderate to highly complex defects, who were prescribed sotalol between 2000 and 2017. Efficacy in treating the clinical arrhythmia was assessed as complete, partial or failure. Adverse effects, including proarrhythmia, were documented. ResultsSotalol was prescribed in 82 of 902 adult CHD patients reviewed (9%). The mean age at sotalol commencement was 31.8 ± 13.1 years, with a median time on sotalol of 2.8 years. The average prescribed dose was 122 ± 51 mg/daily. Sotalol was completely effective in 48% (n = 39), partially effective in 46% (n = 38) and failed to control the clinical arrhythmia in 6% (n = 5). Fifteen patients (18%) discontinued sotalol due to a side effect, most commonly fatigue or dyspnoea. No episodes of torsades de pointes or sudden cardiac death were observed. Significant bradycardia related to sotalol occurred in 13% (n = 11, with permanent pacing implemented in 4), and was associated with Fontan anatomy. ConclusionsIn moderate to highly complex adult CHD, sotalol was reasonably effective and safe in low doses. Side effects limiting treatment were typically non-life-threatening, with significant bradycardia related to sotalol more likely in Fontan patients.

Sotalol versus propafenone for long-term maintenance of normal sinus rhythm in patients with recurrent symptomatic atrial fibrillation

This prospective, randomized, single-blinded, placebo-controlled study compared the efficacy and safety of sotalol and propafenone when used for long-term prevention of atrial fibrillation. For the long-term maintenance of normal sinus rhythm, propafenone seems to be more effective than sotalol.

Efficacy of Sotalol and Amiodarone for Atrial Fibrillation

Background and Objectives:Atrial fibrillation (AF) is the most frequently encountered arrhythmia in clinical practice. Pharmacologic therapy has been advocated for both the immediate restoration of sinus rhythm and the prevention of recurrent AF. Because conventional antiarrhythmic therapy is often ineffective in maintaining sinus rhythm or is associated with adverse side effects in patients with AF, recent interest has been focused on the use of class III antiarrhythmic agents. This study investigated the efficacy and safety of sotalol and amiodarone for the conversion of chronic AF and prevention of recurrent AF. Materials and Method: Thirty six patients with AF were firstly first received sotalol by prospective study protocol. The patients were classified as having paroxysmal AF (PAF, N=12) or chronic AF (CAF, N=24) based on their AF pattern. If the patients with CAF did not convert to sinus rhythm or the patients with PAF recurred in AF, the patients were received a second agentsagent (amiodarone). Patients were followed up for one year. Results:Among the 12 patients with PAF receiving sotalol, 10 (83.3%) patients remained in normal sinus rhythm for an average 9.4±3.6 months. Sotalol was replaced by amiodarone in the remaing remaining 2 patients with arrhythmia recurrence and 1 of the 2 patients remained in sinus rhythm during the follow-up period. In the case of the 24 patients with CAF, conversion to sinus rhythm was achieved in 5 (20.8%) patients with sotalol. Among the patients with CAF who were did not respond to sotalol, 17 patients received amiodarone subsquently and 3 patients successfully converted to sinus rhythm. There were no proarrhythmic effects related to both agents either agent during the study period. Conclusion:Both sotalol and amiodarone appear to be less effective in the termination of CAF, but however the sequential use of these two agents seem to be very effective for the prevention of a recurrence of PAF. (Korean Circulation J 2001;31(2):210-216)

A prospective, randomized controlled trial comparing the efficacy and safety of Sotalol, Amiodarone, and Digoxin for the reversion of new-onset atrial fibrillation

Study Objective: A prospective, randomized controlled trial of new-onset atrial fibrillation was conducted to compare the efficacy and safety of sotalol and amiodarone (active treatment) with rate control by digoxin alone for successful reversion to sinus rhythm at 48 hours. Methods: We prospectively randomly assigned 120 patients with atrial fibrillation of less than 24 hours’ duration to treatment with sotalol, amiodarone, or digoxin using a single intravenous dose followed by 48 hours of oral treatment. Patients had ECG monitoring for 48 hours, and time of reversion, adequacy of rate control, and numbers of adverse events were compared. After 48 hours, those still in atrial fibrillation underwent cardioversion according to a standardized protocol. After 48 hours of therapy and attempted cardioversion, the number of patients whose rhythms had successfully reverted were compared. Results: There was a significant reduction in the time to reversion with both sotalol (13.0±2.5 hours, P <.01) and amiodarone (18.1±2.9 hours, P <.05) treatment compared with digoxin only (26.9±3.4 hours). By 48 hours, the active treatment group was significantly more likely to have reverted to sinus rhythm than the rate control group (95% versus 78%, P <.05; risk ratio 5.4, 95% confidence interval [CI] 1.5 to 19.2 ). In those patients whose rhythms did not revert to sinus rhythm, there was superior ventricular rate control in the sotalol group at both 24 and 48 hours compared with those who received either amiodarone or digoxin. There were also fewer adverse events in the active treatment group compared with the rate control group. Conclusion: Immediate pharmacologic therapy for new-onset atrial fibrillation with class III antiarrhythmic drugs (sotalol or amiodarone) improves complication-free 48-hour reversion rates compared with rate control with digoxin.[Joseph AP, Ward MR. A prospective, randomized controlled trial comparing the efficacy and safety of sotalol, amiodarone, and digoxin for the reversion of new-onset atrial fibrillation. Ann Emerg Med. July 2000;36:1-9.]

Efficacy and safety of sotalol in patients with refractory atrial fibrillation or flutter

Sotalol’s usefulness in treatment of atrial fibrillation and atrial flutter is unproven. This study evaluated (1) the efficacy of sotalol in preventing recurrences of paroxysmal atrial fibrillation or atrial flutter and controlling ventricular rate (in chronic atrial fibrillation or relapse of paroxysmal atrial arrhythmias), (2) the safety of sotalol, and (3) predictors of sotalol efficacy. Thirty-three patients, 28 with paroxysmal and five with chronic atrial fibrillation or atrial flutter, received an average dose of 265 ± 119 mg of oral sotalol per day. During a 10 ± 12 month follow-up, recurrence rate for paroxysmal arrhythmia was 64%, with a 50% recurrence at 4.6 months. For patients with chronic atrial fibrillation, ventricular rates were well controlled with sotalol administration (136 ± 33 beats/min versus 88 ± 23 beats/min; p = 0.04). No patient with chronic atrial fibrillation converted to sinus rhythm during the study. Side effects necessitated sotalol discontinuation in three patients. By multivariate analysis, younger age, higher ejection fraction, and absence of hypertension independently predicted sotalol efficacy. (Am Heart J 1997;134:155-160.)

Multicenter comparative study of the efficacy and safety of sotalol in the prophylactic treatment of patients with paroxysmal supraventricular tachyarrhythmias

We performed a randomized, double-blind, placebo-controled, parallel-group comparison study of the efficacy and safety of sotalol in the prophylaxis of paroxysmal supraventricular tachyarrhythmias (PSVTs) (including paroxysmal atrial fibrillation and paroxysmal reentrant SVTs). The frequency of PSVT episodes while not receiving drug therapy was monitored during a baseline phase, the length of which depended on the frequency of PSVT events. In the double-blind phase, the duration of which depended on the baseline frequency of episodes of PSVT, patients received placebo, sotalol 80 mg twice daily, or sotalol 160 mg twice daily. PSVT events were documented by electrocardiogram and diary. The time to recurrence of PSVT was significantly less compared with placebo when receiving sotalol 80 mg ( p = 0.018) and sotalol 160 mg ( p = 0.0009). On subanalysis, sotalol was shown to be effective in the prophylaxis of both paroxysmal atrial fibrillation and paroxysmal reentrant arrhythmias. Sotalol was well tolerated, with no deaths, proarrhythmia, or cardiac failure. Because of adverse effects, drug therapy was discontinued in six patients. (Am Heart J 1997;133:441-46.)

A perspective on the ESVEM trial and current knowledge: Sotalol should not be the first-line agent in the management of ventricular arrhythmias

The Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial has recently shown the superiority of sotalol over class-I agents in lowering the rate of recurrence of ventricular tachyarrhythmias. However, this study was not placebo-controlled, and amiodarone was not included as one of the antiarrhythmic drugs in the trial. Randomized comparative trials between sotalol and amiodarone are available, but the results are inconclusive mainly because of small sample sizes. Because of the specific pharmacokinetics of amiodarone, sotalol has become the first-line agent in the management of ventricular arrhythmias. Because this policy is based on expediency rather than follow-up data, the long-term efficacy, morbidity, and safety of sotalol should be compared with those of amiodarone as well as of nonpharmacological treatment modes for ventricular tachyarrhythmias, such as implantable cardioverter defibrillator therapy in prospective trials. Until these issues are resolved, it is incorrect to say that sotalol should be the first-line agent in the management of ventricular arrhythmias.

Efficacy and proarrhythmic hazards of pharmacologic cardioversion of atrial fibrillation: Prospective comparison of sotalol versus quinidine

This study compared the efficacy and safety of sotalol and quinidine for conversion and prevention of recurrent atrial fibrillation. Atrial fibrillation is the most common arrhythmia. Pharmacologic therapy has been advocated for both immediate restoration of sinus rhythm and prevention of recurrent atrial fibrillation. Quinidine is the therapeutic mainstay for both purposes, but its safety has recently been questioned. Although sotalol has been used successfully to maintain sinus rhythm after direct current cardioversion, its efficacy in pharmacologically reverting atrial fibrillation has not been examined. Fifty consecutive patients with persistent atrial fibrillation were randomized to receive quinidine or sotalol for up to 7 days to restore sinus rhythm. Patients were followed up for 6 months. Quinidine was more effective than sotalol in terminating atrial fibrillation (60% vs. 20%, p = 0.009). When nonresponders to drug therapy underwent subsequent direct current cardioversion, total conversion rates in the quinidine and sotalol groups were comparable (88% vs. 68%, p = 0.17), as was the efficacy of the two drugs in preventing recurrent atrial fibrillation. Side effects necessitating drug discontinuation were more often observed with quinidine. No patient receiving sotalol but four patients receiving quinidine had drug-associated arrhythmia (torsade de pointes in three patients, sustained ventricular tachycardia in one patient). Precordial QT dispersion determined on the surface electrocardiogram (ECG) increased with quinidine (mean +/- SD 34 +/- 9 vs. 44 +/- 16 ms, p = 0.02), indicating enhanced inhomogeneity in ventricular repolarization. There was no change in QT dispersion in patients receiving sotalol (36 +/- 18 vs. 40 +/- 17 ms, p = 0.44). Quinidine is more effective than sotalol in terminating atrial fibrillation but is associated with more side effects. The proarrhythmic risk may be related to quinidine's propensity to increase disparity in ventricular repolarization. This risk warrants careful ECG monitoring during the 1st 4 to 7 days of therapy. Because most proarrhythmic effects occurred shortly after restoration of sinus rhythm, observation should continue > or = 2 to 3 days after sinus rhythm is reestablished.

Hemodynamic effects and safety of sotalol in the prevention of supraventricular arrhythmias after coronary artery bypass surgery

Sotalol is a β-adrenergic blocking drug with the additional property of lengthening the cardiac action potential. These electrophysiologic properties render the drug attractive for use in the prevention of postoperative supraventricular arrhythmias (SVA), and previous studies have suggested that it was indeed effective. The hemodynamic response to sotalol and its safety early after coronary artery bypass graft (CABG) surgery were therefore studied. Forty-two patients undergoing CABG were randomly assigned either to receive sotalol to prevent postoperative SVA (25 patients) or to serve as controls (17 patients). Sotalol was started 6 hours after surgery if patients had a cardiac index >2.8 L/min/m 2 with a pulmonary capillary wedge pressure <15 mmHg, and if they had no contraindications to the use of β-blockers. The drug was given as a loading infusion of 1 mg/kg over 2 hours, followed by a maintenance infusion of 0.15 mg/kg/h for 24 hours. Three hours later, patients received the first oral dose of 80 mg to be repeated every 8 or 12 hours. Adverse effects necessitating discontinuation of the drug (bradycardia <50 beats/min, systolic blood pressure <90 mmHg, or cardiac index <2.2 L/min/m 2) occurred in six patients (24%) and were mainly related to the loading infusion. The hemodynamic data for patients who completed the study were characterized by a significant fall of the cardiac index caused by a lower heart rate without significant change of the stroke volume index. The incidence of supraventricular arrhythmias was not significantly different in the two groups ( 3 19 in the sotalol group, 5 17 in the control group). In conclusion, at the dosage used, sotalol was associated with a high incidence of adverse reactions, precluding the enrollment of enough patients to assess a possible efficacy in the prevention of postoperative SVA. Bradycardia, accompanied by a significant decrease of cardiac index, was found. Therefore, it is concluded that this drug should be used very cautiously after coronary artery surgery.

Clinical safety profile of sotalol in the treatment of arrhythmias

The safety of sotalol was evaluated in 3,257 patients treated for cardiac arrhythmias in double-blind and open-label clinical trials that support United States registration of the drug. In this composite population, 80% of patients had structural heart disease and 42% had life-threatening ventricular arrhythmias, I.e., ventricular tachycardia ] (VT) or fibrillation (VF). Proarrhythmia was reported in 141 patients (4.3%). Of these, 78 (2.4%) had torsades de pointes and 26 (0.8%) had sustained VT or VF. The overall incidence was higher in patients treated for sustained VT or VF (6.5%). In these patients, serious proarrhythmia was predominantly torsades de pointes (4.1%) and was more prevalent in patients with congestive heart failure and low ejection fraction. Torsades de pointes was observed early in the course of treatment, and its occurrence was related to dose. The overall mortality in patients treated with sotalol was 4.3% (139 patients); in patients with life-threatening arrhythmias, cardiac mortality was 4.8%. In only 27 patients (0.8%) was the death thought to be potentially drug-related. The deaths were not related to dose. Data from a previously reported placebo-controlled postmyocardial infarction trial indicated no significant difference in mortality between sotalol and placebo. Heart failure was reported in 3.3% of patients and was most prevalent in those with a previous history of congestive heart failure, cardiomyopathy, or structural heart disease. The occurrence of heart failure was unrelated to dose or time on drug; in more than half of the patients, sotalol treatment was continued. On average, there was no decrease in ejection fraction. Reported adverse drug experiences were typical of β blockers and resulted in discontinuation of the drug in 18% of patients. There was no evidence of organ toxicity or interaction with concomitant therapy. As an antiarrhythmic agent, sotalol is generally well tolerated and has a favorable profile relative to that reported for many other agents.

Efficacy and safety of sotalol in digitalized patients with chronic atrial fibrillation

Efficacy and safety of sotalol in digitalized patients with chronic atrial fibrillation

Sotalol versus quinidine in the maintenance of sinus rhythm after direct current conversion of atrial fibrillation

This open, parallel-group, multicenter study was conducted to compare the efficacy and safety of sotalol with that of quinidine for the prevention of atrial fibrillation relapse following DC conversion 183. DC-converted 183 patients with a 1- to 12-month history of atrial fibrillation were randomized to sotalol or quinidine after 2 hours of sinus rhythm following the conversion and followed on treatment for 6 months. The efficacy of sotalol and quinidine for the prevention of atrial fibrillation relapse during a 6-month period following DC conversion was similar. However, sotalol was better tolerated than quinidine.

The efficacy and safety of sotalol in digitalized patients with cronic atrial fibriliation

The efficacy and safety of sotalol in digitalized patients with cronic atrial fibriliation

Sotalol for refractory sustained ventricular tachycardia and nonfatal cardiac arrest

The efficacy and safety of sotalol were assessed by electrophysiologic testing and ambulatory recordings in 16 patients with recurrent sustained ventricular tachycardia (VT) or nonfatal cardiac arrest who were refractory to an average of 4.8 conventional antiarrhythmic agents. Twenty-four-hour ambulatory recordings were performed before and after sotalol therapy. Fourteen patients underwent baseline electrophysiologic study and sustained VT was inducible in 12. Oral sotalol (320 to 960 mg/ day) completely suppressed inducible sustained VT in 7 patients (58%), with modification in 3 (25%). Ventricular premature complexes were suppressed from baseline (mean ± standard deviation) 431 ± 616 to 60 ± 110/hr (p < 0.03). After a mean follow-up of 19 ± 7 months, 12 of 14 patients receiving sotalol treatment had successful suppression of ventricular premature complexes (60 ± 85/hr) and remained clinically free of sustained VT, except 2 who needed additional antiarrhythmic drugs to suppress the recurrent sustained VT. One patient died suddenly after 25 months of sotalol treatment. No severe side effects were noted during sotalol therapy. This study demonstrates that sotalol is a well-tolerated, effective antiarrhythmic agent in patients at high-risk for sudden death. It appears to be beneficial in patients who did not benefit from multiple drug treatment.