Chemical structure of amiodarone
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Cordarone

Amiodarone belongs to a class of drugs called Vaughan-Williams Class III antiarrhythmic agent. It is used in the treatment of a wide range of cardiac tachyarhthmias, including both ventricular and supraventricular (atrial) arrhythmias. The chemical name for amiodarone is 2-butyl-3-benzofuranyl 4--3,5-diiodophenyl ketone hydrochloride. more...

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History

Amiodarone was initially developed in 1961 in Belgium as a treatment for angina. It was widely used throughout Europe as an anti-anginal medication, and was soon found to suppress arrhythmias.

Dr. Bramah Singh determined that amiodarone and sotalol belonged to a new class of antiarrhythmic agents (what would become the class III antiarrhythmic agents) that would prolong repolarization of the cardiac action potential. Based on this, the Argentinian physician Dr. Mauricio Rosenbaum began using amiodarone to treat his patients who suffered from supraventricular and ventricular arrhythmias, with impressive results. Based on papers written by Dr. Rosenbaum, physicians in the United States began prescribing amiodarone to their patients with potentially life-threatening arrhythmias in the late 1970s. By that time, amiodarone was commonly prescribed throughout Europe for the treatment of arrhythmias. Because amiodarone was not approved by the FDA for use in the United States at the time, physicians were forced to directly obtain amiodarone from pharmaceutical companies in Canada and Europe.

The FDA was reluctant to officially approve the use of amiodarone, since initial reports had shown increased incidence of serious pulmonary side-effects of the drug. In the mid 1980s, the European pharmaceutical companies began putting pressure on the FDA to approve amiodarone by threatening to cut the supply to the American physicians if it was not approved. In December of 1985, amiodarone was approved by the United States FDA for the treatment of arrhythmias. This makes amiodarone one of the few drugs approved by the FDA without rigorous randomized clinical trials.

Dosing

Amiodarone is available in oral and intravenous formulations. Orally, it is available under the trade names Pacerone® (produced by Upsher-Smith Laboratories, Inc.) and Cordarone® (produced by Wyeth-Ayerst Laboratories) in 200 mg and 400 mg tablets. It is also available in intravenous ampules and vials, typically in 150mg increments.

The dose of amiodarone administered is tailored to the individual and the dysrhythmia that is being treated. When administered orally, the bioavailability of amiodarone is quite variable. Absorption ranges from 22 to 95%, with better absorption when it is given with food.

Amiodarone is fat-soluble, and tends to concentrate in tissues including fat, muscle, liver, lungs, and skin. This confers a high volume of distribution (5000 liters in a 70kg adult) and a long half-life. Due to the long half-life of amiodarone, oral loading typically takes days to weeks.

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Amiodarone vs. ICD for Treatment of CHF
From American Family Physician, 11/1/05 by Chuck Carter

Patients with congestive heart failure (CHF) are at high risk of fatal ventricular arrhythmias; however, there are limited data on the effectiveness of preventive interventions. Bardy and colleagues conducted a randomized placebo-controlled trial comparing the effects of conventional therapy plus amiodarone (Cordarone), an implantable cardioverter-defibrillator (ICD), or placebo on all-cause mortality in patients with CHF.

Investigators enrolled 2,521 patients who were New York Heart Association (NYHA) class II or III CHF and had a left ventricular ejection fraction of 35 percent or less (median: 25 percent). The etiology of CHF could be ischemic or nonischemic. Participants were primarily white men (77 percent). All patients received standard therapy for CHF, including angiotensin-converting enzyme (ACE) inhibitors and beta blockers when clinically appropriate.

Patients were randomized to receive amiodarone, an ICD, or placebo. Placebo and amiodarone administration was double blind and partially weight based (average dose: 300 mg). Defibrillators were set up in single-lead, shock-only mode because the primary intention was to treat sustained ventricular tachycardia or ventricular fibrillation. The three groups were similar in size lowed for at least two years; median follow-up was 45.5 months.

Discontinuation rates for drug therapy were 22 percent for placebo and 32 percent for amiodarone. Seven percent of patients in the medication and placebo groups ended up on open-label amiodarone, and 14 percent of patients in the ICD group crossed over to open-label amiodarone during follow-up. Eleven percent of patients in the drug and placebo groups crossed over to an ICD. The most common negative side effects of amiodarone were tremor (4 percent) and increased hypothyroidism (6 percent). Complications in the ICD group occurred as well, with 5 percent of participants having problems at the time of implantation and 9 percent during follow-up. This included events necessitating surgery, hospitalization, or other medical therapy.

Death occurred in 29 percent of patients receiving placebo, 28 percent of patients receiving amiodarone, and 22 percent of patients in the ICD group. Thus, ICD use reduced the risk of death by 7 percent. Amiodarone did not make a significant difference.

Approximately one third of patients in the ICD group received shocks from their devices, with 68 percent being shocked for rapid ventricular tachycardia or ventricular fibrillation. ICD therapy led to a significant absolute reduction in mortality of 11.9 percent in patients with NYHA class II CHF but no significant risk reduction in patients with NYHA class III CHF. Amiodarone did not decrease risk of death in patients with NYHA class II CHF, but it relatively increased the risk of death by 44 percent in patients with NYHA class III CHF. The use of ICDs reduced the absolute risk of death by 7.2 percent at five years, whereas amioda-rone therapy showed no benefit.

The authors conclude that conservatively programmed, shock-only ICDs significantly decrease the relative risk of death in patients with CHF, whereas amiodarone has no positive effect on survival. Other defibrillator studies have shown increased benefit for patients with lower ejection fractions or with NYHA class III CHF. Thus, the lack of benefit found for patients with NYHA class III CHF in this study should be considered in the context of the larger evidence base. Because this study used only single-lead, shock-only treatment, these findings may not apply to all types of ICDs.

CHUCK CARTER, M.D.

Bardy GH, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure [published correction appears in N Engl J Med May 19, 2005;352:2146]. N Engl J Med January 20, 2005;352:225-37.

EDITOR'S NOTE: In an accompanying editorial, (1) McClellan and Tunis discuss how the Centers for Medicare and Medicaid Services (CMS) will respond to this study. In short, CMS will expand coverage, coordinate patient registries, and support clinical outcomes research. Physicians should know that CMS will use the evidence derived from this process to inform future coverage decisions. At an estimated reimbursement of $30,000 per ICD for the potentially 500,000 newly covered patients, this type of evidence-informed oversight seems appropriate. For now, the evidence is trending toward ICDs as a routine addition to the CHF armamentarium. Thus, family physicians should consider whether their patients with CHF are at high risk for arrhythmia and consult for this intervention after discussing the risks and benefits. Furthermore, this should prompt reevaluation of the entire treatment plan. Often patients are not receiving proven treatments (e.g., angiotensin-converting enzyme inhibitors, beta blockers), and the outcomes observed in this trial were in patients on appropriate medical therapy.--C.C.

REFERENCE

(1.) McClellan MB, Tunis SR. Medicare coverage of ICDs. N Engl J Med 2005;352;222-4.

COPYRIGHT 2005 American Academy of Family Physicians
COPYRIGHT 2005 Gale Group

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