BOX WARNING
Cordarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
Cordarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time. Liver injury is common with Cordarone, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Like other antiarrhythmics, Cordarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. This has occurred in 2 to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5%. All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with Cordarone than with many other agents used in this population, the effects are prolonged when they occur.
Even in patients at high risk of arrhythmic death, in whom the toxicity of Cordarone is an acceptable risk, Cordarone poses major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first.
The difficulty of using Cordarone effectively and safely itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose of Cordarone is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. In a retrospective survey of 192 patients with ventricular tachyarrhythmias, 84 required dose reduction and 18 required at least temporary discontinuation because of adverse effects, and several series have reported 15 to 20% overall frequencies of discontinuation due to adverse reactions. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months. The patient is obviously at great risk during this time and may need prolonged hospitalization. Attempts to substitute other antiarrhythmic agents when Cordarone must be stopped will be made difficult by the gradually, but unpredictably, changing amiodarone body burden. A similar problem exists when Cordarone is not effective; it still poses the risk of an interaction with whatever subsequent treatment is tried.
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CORDARONE SUMMARY
Cordarone (amiodarone HCl) is a member of a new class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects, available for oral administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride.
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see “WARNINGS” below), Cordarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.
- Recurrent ventricular fibrillation.
- Recurrent hemodynamically unstable ventricular tachycardia.
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of Cordarone Tablets favorably affects survival.
Cordarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with Cordarone should be carried out in the hospital.
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CORDARONE NEWS HIGHLIGHTS Media Articles Related to Cordarone (Amiodarone)
Sleep Disorders Linked to Arrhythmias
Source: MedicineNet Atrial Fibrillation 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
Sleep Disorders Linked to Arrhythmias (HealthDay)
Source: Y! Health News Search RSS Feed [2009.06.23]
HealthDay - TUESDAY, June 23 (HealthDay News) -- Older men who have severe
sleep-related breathing problems are at increased risk for abnormal heart
rhythms, a U.S. study finds.
Older Men With Breathing Problems During Sleep More Likely To Have Irregular Heartbeats
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2009.06.24]
Increasingly severe sleep-related breathing disorders in older men appear to be associated with a greater risk of abnormal heart rhythms (arrhythmias), according to a report in the June 22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. In addition, different types of breathing problems appear more closely associated with different categories of arrhythmia.
Atrial Fibrillation In Endurance Athletes Still Poses Problems For Sports Cardiologists
Source: Sports Medicine / Fitness News From Medical News Today [2009.06.22]
The fulfilment which so many people increasingly derive from competitive sports and endurance training comes with a real - even if rare - twist. Because, while most people will enjoy the benefits and pleasures of exercise, there are a few for whom regular athletic training will increase the risk of cardiac arrhythmias and even sudden death, especially among those in middle-age or with pre-existing cardiac diseases.
Published Studies Related to Cordarone (Amiodarone)
Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial. [2008.10.15]
CONTEXT: Amiodarone [generic for Cordarone] effectively suppresses atrial fibrillation but causes many adverse events. OBJECTIVE: To compare major events in patients randomized to receive episodic amiodarone treatment with those who received continuous amiodarone treatment while still aiming to prevent atrial fibrillation... CONCLUSIONS: In this study population, there was no difference in the composite of amiodarone and cardiac major adverse events between groups. However, patients receiving episodic treatment had a significantly increased rate of atrial fibrillation recurrence and a significantly higher rate of all-cause mortality and cardiovascular hospitalizations. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00392431.
Quality of life with defibrillator therapy or amiodarone in heart failure. [2008.09.04]
BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy significantly prolongs life in patients at increased risk for sudden death from depressed left ventricular function. However, whether this increased longevity is accompanied by deterioration in the quality of life is unclear... CONCLUSIONS: In a large primary-prevention population with moderately symptomatic heart failure, single-lead ICD therapy was not associated with any detectable adverse quality-of-life effects during 30 months of follow-up. 2008 Massachusetts Medical Society
Combination therapy with amiodarone and enalapril in patients with paroxysmal atrial fibrillation prevents the development of structural atrial remodeling. [2008.07]
The purpose of this study was to examine the relationship between long-term efficacy of amiodarone [generic for Cordarone] therapy (100-200 mg/day) combined with angiotensin converting enzyme inhibitor (ACEI; enalapril 5 mg/day) administration, and the development of structural atrial remodeling in patients with paroxysmal atrial fibrillation (AF)... In patients with paroxysmal AF, ACE-I appears to enhance the efficacy of amiodarone therapy in maintaining sinus rhythm and preventing the development of structural remodeling in atria.
Amiodarone protects diabetics and non-diabetics undergoing coronary artery bypass grafting equally. [2008.06]
OBJECTIVE: To evaluate amiodarone [generic for Cordarone] prophylaxis in diabetics and non-diabetics. Further to clarify whether the risk of developing atrial fibrillation is higher for diabetics than non-diabetic patients, and to evaluate whether the diabetic status has any influence on the length of in-hospital stay... CONCLUSIONS: Diabetics and non-diabetics had the same effect of the amiodarone prophylaxis regime. Atrial fibrillation developed equally among diabetics and non-diabetics, but the length of stay was prolonged for diabetics.
Amiodarone cost effectiveness in preventing atrial fibrillation after coronary artery bypass graft surgery. [2008.01]
BACKGROUND: The purpose of this study was to estimate the costs and health benefits of routinely administered postoperative amiodarone [generic for Cordarone] as prevention of atrial fibrillation for patients undergoing coronary artery bypass grafting (CABG) for stable angina... CONCLUSIONS: Routine use of postoperative prophylactic intravenous bolus and subsequent 5 days of oral amiodarone therapy after coronary artery bypass grafting reduces the risk of atrial fibrillation and decreases the total costs of care by 175 euros per patient.
Clinical Trials Related to Cordarone (Amiodarone)
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft [Completed]
Relative Bioavailability of PM101 IV and Cordarone IV [Completed]
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment [Completed]
The objective of this study is to determine if concentrations of amiodarone in fat tissue
increase constantly over time during chronic treatment with this drug, and if blood
concentrations reflect accurately the concentrations in fat tissue or not. This is because
excessive concentrations of this drug in tissues can produce adverse effects.
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation [Completed]
Our hypothesis is that episodic amiodarone treatment (i. e. amiodarone treatment 1 month prior
until 1 month after cardioversion) is associated with a lower morbidity and a higher quality
of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is
still effectively suppressed. The latter means that at the end of the study permanent atrial
fibrillation is prevented in comparable percentage of patients (70%) in both treatment
strategies. However, this will be accomplished at the cost of a higher number of electrical
cardioversions (2-3) in the episodic treatment group compared to the continuous treatment
group.
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [Recruiting]
The primary objective of the study is to demonstrate the superiority of vernakalant injection
over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR)
within 90 minutes of the start of drug administration. The secondary objective is to compare
the safety of vernakalant to amiodarone.
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Page last updated: 2009-06-24
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