To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see
DOSAGE AND ADMINISTRATION. TIKOSYN is available only to hospitals and prescribers who have received appropriate TIKOSYN dosing and treatment initiation education; see
DOSAGE AND ADMINISTRATION.
TIKOSYN (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties.
TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because TIKOSYN can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic.
In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. (See CLINICAL TRIALS.)
TIKOSYN is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
TIKOSYN has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Published Studies Related to Tikosyn (Dofetilide)
Risk factors and predictors of Torsade de pointes ventricular tachycardia in patients with left ventricular systolic dysfunction receiving Dofetilide. [2007.09.01]
The purpose of this study was to identify risk factors of Torsade de pointes (TdP) ventricular tachycardia in patients medicated with a class III antiarrhythmic drug (dofetilide) and left ventricular systolic dysfunction with heart failure (HF) or recent myocardial infarction (MI)... Patients with recent MI less often had TdP compared with patients with chronic HF.
An evaluation of the impact of oral magnesium lactate on the corrected QT interval of patients receiving sotalol or dofetilide to prevent atrial or ventricular tachyarrhythmia recurrence. [2006.04]
BACKGROUND: Intravenous magnesium reduces the QTc interval of patients receiving ibutilide. Whether oral magnesium can reduce the QTc interval associated with oral sotalol and dofetilide is not known. This study was undertaken to evaluate the impact of oral magnesium on the QTc interval and whether an inherent intracellular magnesium deficiency exists among patients with arrhythmias... CONCLUSIONS: Oral magnesium l-lactate raises intracellular magnesium concentrations and lowers the QTc interval of patients receiving sotalol or dofetilide.
Phase IV trial evaluating the effectiveness and safety of dofetilide. [2004.07]
BACKGROUND: Dofetilide gained Food and Drug Administration approval for persistent atrial fibrillation/flutter (AFF) based on 2 randomized, placebo-controlled, dose-ranging studies. Concerns of proarrhythmia have prompted the manufacturer to develop specific treatment guidelines. OBJECTIVE: To determine the effectiveness and safety of dofetilide in clinical practice as well as to ascertain whether clinicians are following established dosing guidelines... CONCLUSIONS: In clinical practice, the conversion of persistent AFF with dofetilide is at least comparable to premarketing studies, with a similar safety profile. Institutions should continue to emphasize adherence with established treatment guidelines.
The prognostic value of QTc interval and QT dispersion following myocardial infarction in patients treated with or without dofetilide. [2003.05]
BACKGROUND: Acute myocardial infarction (MI) is associated with an increased risk of death, with a 1-year mortality close to 10% in patients discharged from hospital alive. During the first year following MI, close to 50% of deaths are assumed to be due to arrhythmic events. HYPOTHESIS: The study was undertaken to determine the interaction between dofetilide treatment and pretreatment QTc interval and QT dispersion regarding mortality in patients with left ventricular (LV) dysfunction and a recent MI... CONCLUSION: In patients with a recent MI, LV dysfunction, and a short baseline QTc interval, dofetilide is associated with significant survival benefit. This benefit is not seen with a longer QTc interval. QT dispersion is not a risk factor in this population.
Survival after withdrawal of dofetilide in patients with congestive heart failure and a short baseline QTc interval; a follow-up on the Diamond-CHF QT substudy. [2003.02]
BACKGROUND: We have previously observed dofetilide to be associated with improved survival when the pre-treatment baseline QTc interval was below 429 ms. In this study we tested the natural extension of this observation-that the same group of patients should have a loss of survival benefit after withdrawal of dofetilide... CONCLUSIONS: This follow-up study shows significant loss of survival benefit upon withdrawal of dofetilide in patients with CHF and a pre-treatment QTc interval below 429 ms. An independent randomized trial is warranted to validate these results.
Clinical Trials Related to Tikosyn (Dofetilide)
Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block [Completed]
The primary objective of this research study is to test the hypothesis that late sodium
current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium
channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early
repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel
block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).
Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults [Completed]
This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with
dofetilide-induced QTc prolongation.
Genetics of QT Prolongation With Antiarrhythmics [Recruiting]
To assess the ability of common genetic variants in aggregate to predict drug-induced QT
prolongation in patients being loaded with dofetilide or sotalol, and validate the
feasibility of using a smartphone device for measuring QT interval.
PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide [Not yet recruiting]
To determine the efficacy of cryoablation alone in patients with paroxysmal atrial
fibrillation who have been pretreated with dofetilide and converted from persistent atrial
Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects [Completed]
This study seeks to compare 4 known QT prolonging drugs versus placebo to determine their
effects on electrophysiological and other clinical parameters. The underlying purpose is to
determine if depolarization and repolarization effects caused by drugs with differing ionic
channel mechanisms can be distinguished from one another, and to gauge the sensitivity and
specificity of novel signal analyses for detection of depolarization and repolarization
changes. Secondarily, to evaluate the exposure response relationship and drug induced
effects on the heart rate biomarker relationship.
Reports of Suspected Tikosyn (Dofetilide) Side Effects
Electrocardiogram QT Prolonged (33),
Drug Ineffective (32),
Atrial Fibrillation (32),
Drug Interaction (21),
Dyspnoea (20), more >>
Page last updated: 2007-10-19