BOX WARNING
To minimize the risk of induced arrhythmia, patients initiated or reinitiated on BETAPACE® should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Creatinine clearance should be calculated prior to dosing. For detailed instructions regarding dose selection and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION. Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name BETAPACE AF™. BETAPACE is not approved for the AFIB/AFL indication and should not be substituted for BETAPACE AF because only BETAPACE AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.
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BETAPACE SUMMARY
Mortality
BETAPACEŽ (sotalol hydrochloride) is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a light-blue, capsule-shaped tablet for oral administration.
Oral BETAPACE (sotalol hydrochloride) is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of BETAPACE (see WARNINGS), including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of BETAPACE treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including BETAPACE.
In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of nonsustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure.
In a multicenter open-label long-term study of BETAPACE in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name BETAPACE AF. BETAPACE is not approved for the AFIB/AFL indication and should not be substituted for BETAPACE AF because only BETAPACE AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.
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NEWS HIGHLIGHTSMedia Articles Related to Betapace (Sotalol)
Sleep Disorders Linked to Arrhythmias
Source: MedicineNet Sleep Apnea Specialty [2009.06.24]
Title: Sleep Disorders Linked to Arrhythmias
Category: Health News
Created: 6/24/2009 7:00:00 AM
Last Editorial Review: 6/24/2009
Published Studies Related to Betapace (Sotalol)
The Drug And Pace Health cliNical Evaluation (DAPHNE) study: a randomized trial comparing sotalol versus beta-blockers to treat symptomatic atrial fibrillation in patients with brady-tachycardia syndrome implanted with an antitachycardia pacemaker. [2008.08]
BACKGROUND: Atrial tachyarrhythmias (ATAs) are mainly treated by pharmacologic therapy for rate control or rhythm control. The aim of our study was to compare sotalol (S) versus beta-blocking agents (BB) in terms of prevention of ATA, cardioversions (CVs), and cardiovascular hospitalizations (H) in patients paced for bradycardia-tachycardia form of sinus node disease (BT-SND)... CONCLUSIONS: In the complex context of "hybrid therapy" in patients with BT-SND implanted with a modern dual chamber rate adaptive pacemaker device delivering atrial antitachycardia pacing, no differences were found between the use of beta-blocker and the use of S, at the relatively low dose achieved after clinical titration, in terms of prevention of cardiovascular H or need for atrial CV.
Bifocal versus unifocal right atrial pacing under plasma level controlled sotalol to prevent atrial fibrillation in patients with symptomatic sinus bradycardia and paroxysmal atrial fibrillation. [2007.12]
AIMS : Bifocal right atrial pacing (BP) has been reported to increase arrhythmia-free intervals in patients with paroxysmal atrial fibrillation (PAF) under antiarrhythmic drugs. This study compares AF burden with unifocal pacing (UP) vs BP under sotalol...
The clinical noncompliance of oral sotalol/magnesium for prophylactic treatment of atrial fibrillation after coronary artery bypass grafting. [2007.07]
BACKGROUND: Postoperative atrial fibrillation has been refractory to many attempted pharmacologic prevention methods and, when effective, side effects have been described. The present aim was to study the clinical compliance of a suggested prophylactic treatment, oral sotalol, and magnesium... CONCLUSIONS: The tested treatment protocol showed limited compliance among routine cardiac-surgery patients, and further, introduced a biased selection of patients that skewed the results and may have partly explained the treatment effect.
Exercise capacity in atrial fibrillation: a substudy of the Sotalol-Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T). [2007.04]
BACKGROUND: Therapy for chronic atrial fibrillation (AF) focuses on rate versus rhythm control, but little is known about the effects of common therapeutic interventions on exercise tolerance in AF... CONCLUSION: Cardioversion resulted in a sustained improvement in exercise capacity over the course of 1 year, and this improvement was similar between those in SR and those with SR and recurrent AF. Patients most likely to improve with treatment tended to be younger and nonobese and have the greatest limitations initially.
Azimilide vs. placebo and sotalol for persistent atrial fibrillation: the A-COMET-II (Azimilide-CardiOversion MaintEnance Trial-II) trial. [2006.09]
CONCLUSION: This study demonstrates that the anti-arrhythmic efficacy of azimilide is slightly superior to placebo but significantly inferior to sotalol in patients with persistent AF. The modest anti-arrhythmic efficacy and high rate of torsade de pointes and marked QTc prolongation limit azimilide utilization for the treatment of AF.
Clinical Trials Related to Betapace (Sotalol)
Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation [Recruiting]
The main objective is to research for genetic factors involved in the extreme modifications
of the QT interval of the electrocardiogram in answer to a pharmacological stimulation
(sotalol) and physiological stimulation in the apparently normal general population.
The phenotypic characterization, based on the ventricular repolarisation dynamics will be
used aiming at term of the predictive genetic factors of the acquired long QT syndrome
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Recruiting]
PS-023 is a randomized controlled clinical study. The purpose of this study is to determine
whether this new catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable
Sheath) is safe and effective for the treatment of paroxysmal atrial fibrillation, as well as
to see if this treatment is better compared to a medication. This catheter system uses
freezing energy, cryoablation, to ablate (destroy) abnormal tissue in or near the pulmonary
veins. A refrigerant (cooling material) is delivered within the catheter to cool the
catheter tip. This freezes and destroys the cells at the entrance to the pulmonary veins. If
the atrial fibrillation comes from somewhere else in the heart, another catheter, the Freezor
MAX, will be used to freeze that area. This experimental catheter also uses freezing to
ablate abnormal tissue. Many atrial fibrillation patients also have another arrhythmia
called atrial flutter. In order to treat or to prevent atrial flutter after the procedure,
the Freezor MAX catheter may be used to freeze the cells in the area of the heart where
atrial flutter starts.
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study [Recruiting]
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation
with pacing device therapy will reduce death and hospitalization when compared to the
conventional drug therapy in elderly patients with recurrent and symptomatic atrial
fibrillation (AF).
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial [Recruiting]
CABANA is designed to test the hypothesis that the treatment strategy of percutaneous left
atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is
superior to current state-of-the-art therapy with either rate control or anti-arrhythmic
drugs for reducing total mortality (primary endpoint) and decreasing the composite endpoint
of total mortality, disabling stroke, serious bleeding and cardiac arrest (secondary
endpoint) in patients with untreated or incompletely treated AF warranting therapy.
Ablation Versus Anti-Arrhythmic (AA) Drug Therapy for AF - Pivotal Trial [Not yet recruiting]
The CABANA Trial has the overall goal of establishing the appropriate roles for medical and
ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the
hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of
eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy
with either rate control or rhythm control drugs for reducing total mortality in patients
with untreated or incompletely treated AF.
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Page last updated: 2009-06-24
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