LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT
CORVERT can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of CORVERT. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia). It is essential that CORVERT be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. Patients with atrial fibrillation of more than 2 to 3 days' duration must be adequately anticoagulated, generally for at least 2 weeks.
CHOICE OF PATIENTS
Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm (see CLINICAL STUDIES) and treatments to maintain sinus rhythm carry risks. Patients to be treated with CORVERT, therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of CORVERT, and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.
|
| |
CORVERT SUMMARY
Corvert®
ibutilide fumarate injection
CORVERT Injection (ibutilide fumarate injection) is an antiarrhythmic drug with predominantly class III (cardiac action potential prolongation) properties according to the Vaughan Williams Classification. Each milliliter of CORVERT Injection contains 0.1 mg of ibutilide fumarate (equivalent to 0.087 mg ibutilide free base), 0.189 mg sodium acetate trihydrate, 8.90 mg sodium chloride, hydrochloric acid to adjust pH to approximately 4.6, and Water for Injection. CORVERT Injection is an isotonic, clear, colorless, sterile aqueous solution. Ibutilide fumarate has one chiral center, and exists as a racemate of the (+) and (−) enantiomers.
CORVERT Injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to CORVERT. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.
|
NEWS HIGHLIGHTS
Published Studies Related to Corvert (Ibutilide)
Propafenone added to ibutilide increases conversion rates of persistent atrial fibrillation. [2006.05]
CONCLUSION: Concurrent administration of propafenone plus ibutilide for pharmacological cardioversion of persistent AF is safe and more effective than ibutilide alone.
Is pretreatment with ibutilide useful for atrial fibrillation cardioversion when combined with biphasic shock? [2006.02]
OBJECTIVE: Cardioversion of atrial fibrillation by means of a monophasic transthoracic shock is facilitated by pretreatment with ibutilide. The aim of this study was to randomly and prospectively compare the energy requirements of transthoracic biphasic cardioversion of atrial fibrillation with and without ibutilide pretreatment... CONCLUSIONS: Although not essential for a successful outcome, pretreatment with ibutilide can lower energy requirements in transthoracic biphasic cardioversion.
Comparison of intravenous ibutilide vs. propafenone for rapid termination of recent onset atrial fibrillation. [2005.12]
This study was to evaluate the efficacy and safety of ibutilide and propafenone given intravenously in converting recent onset atrial fibrillation (AF). Eighty-two consecutive patients with AF (onset in 2 h to 90 days) were randomly assigned to receive two 10-min infusions, 10 min apart, of either ibutilide (1 mg) or propafenone (70 mg).
The combined use of ibutilide as an active control with intensive electrocardiographic sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval. [2005.08.16]
OBJECTIVES: This study was designed to evaluate effects of tadalafil, a phosphodiesterase-5 inhibitor used for the treatment of erectile dysfunction (ED), on the QT interval. BACKGROUND: Cardiovascular disease is common in men with ED. Men with cardiovascular disease and ED may have decreased cardiac repolarization reserve... CONCLUSIONS: Based on the a priori statistical test of equivalence, placebo and high-dose tadalafil produced equivalent effects on the QT interval. This study reliably discerned 5- to 10-ms changes in corrected QT in the ibutilide active control group.
[Immediate cardioversion of atrial fibrillation and atrial flutter lasting less than 90 days by ibutilide versus propafenone: a multicenter study] [2005.03.30]
OBJECTIVE: To compare the efficacy and safety of ibutilide versus propafenone in immediate cardioversion of atrial fibrillation (AF) and atrial flutter (AFL) lasted less than 90 days... CONCLUSION: Intravenous administration of ibutilide in cardioversion of AF and AFL is safe and effective.
Clinical Trials Related to Corvert (Ibutilide)
Ibutilide Administration During Pulmonary Vein Ablation [Recruiting]
To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide
will be administered intravenously in patients undergoing an Afib ablation. The hypothesis
of this study is that ibutilide will decrease the high frequency signals observed in Afib
suggesting the presence of micro reentrant circuits as the basic mechanism of Afib,
especially for the paroxysmal Afib group. The potential difference in response to the
ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the
underlying mechanism of Afib between these two groups.
|
|
|
|
Page last updated: 2007-02-12
|
