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(Chest. 2002;121:19-23.)
© 2002 American College of Chest Physicians

Clinical Observations With the Amiodarone/Warfarin Interaction*

Dosing Relationships With Long-term Therapy

Cynthia A. Sanoski, PharmD and Jerry L. Bauman, PharmD

* From the Departments of Pharmacy Practice and Medicine, Section of Cardiology (Dr. Bauman), University of Illinois at Chicago, Chicago, IL; and the Department of Pharmacy Practice and Administration (Dr. Sanoski), Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Philadelphia, PA.

Correspondence to: Jerry L. Bauman, PharmD, University of Illinois at Chicago 833 Wood St, M/C 886, Chicago, IL 60612; e-mail: jbauman{at}uic.edu


   Abstract
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 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Objectives: The interaction between amiodarone and warfarin has only been described in patients being followed up for relatively short time periods. The objectives of this study were to characterize the interaction between these two agents in a clinical situation over a longer period of time in a larger cohort of patients, and to determine the relationship between the maintenance dose of amiodarone and the resultant need to adjust the dose of warfarin.

Design: This was an observational trial of a cohort of patients receiving a stable warfarin regimen in whom oral amiodarone was initiated. Patients received both amiodarone and warfarin for at least 1 year, and the dosage of warfarin was adjusted as clinically necessary to achieve an international normalized ratio of 2 to 3. Data from a total of 43 patients were analyzed.

Results: At baseline, prior to initiation of amiodarone, the warfarin dose was 5.2 ± 2.6 mg/d. The magnitude of the interaction between these two agents peaked at 7 weeks, which resulted in a 44% mean maximum reduction in the warfarin dose. The warfarin dose inversely correlated with the maintenance dose of amiodarone (r2 = 0.94, p < 0.005). Minor bleeding episodes occurred in five patients (12%). For patients receiving amiodarone maintenance doses of 400, 300, 200, or 100 mg/d, it is recommended that the daily warfarin dose be reduced by approximately 40%, 35%, 30%, or 25%, respectively.

Conclusions: The magnitude of the amiodarone/warfarin interaction is highly dependent on the maintenance dose of amiodarone. This relationship can aid clinicians in adjusting the dose of warfarin patients receiving long-term amiodarone treatment.

Key Words: amiodarone • drug/drug interaction • warfarin


   Introduction
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 Abstract
 Introduction
Materials and Methods
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 Discussion
 References
 
Numerous studies1 2 3 4 5 have demonstrated the efficacy of amiodarone in the management of both supraventricular and life-threatening ventricular arrhythmias. Unlike the class I agents, amiodarone possesses minimal proarrhythmic effects and has not been associated with an increased risk of mortality.6 Consequently, in view of these clinical benefits, many clinicians have begun to consider amiodarone as first-line antiarrhythmic therapy, especially for those patients with compromised ventricular function or coronary artery disease.7 8 9 10 Despite these clinical advantages, the use of amiodarone is complicated by its extensive adverse effect profile and complex drug interactions.

One of the most frequently encountered drug interactions with amiodarone is with the anticoagulant warfarin. Because of their increased risk for thromboembolic events, patients with atrial fibrillation/flutter, prosthetic valves, left ventricular dysfunction, and/or a history of thromboembolic disorders require prophylactic anticoagulation with warfarin. Symptomatic supraventricular and/or ventricular arrhythmias will also develop in many of these patients, who may require the use of an antiarrhythmic, of which amiodarone is the most frequently employed.

Amiodarone strongly potentiates the anticoagulant effects of warfarin, resulting in prolongation of the international normalized ratio (INR) and increased risk of bleeding. Although commonly encountered in clinical practice, this interaction has only been described in the literature in studies with limited numbers of patients being followed up for relatively short periods of time.11 12 13 14 15 16 17 18 However, because of the prolonged and variable elimination half-life of amiodarone, it is possible that these data may not be sufficient to fully characterize this drug interaction. Moreover, although most practitioners are cognizant of the recommendations for reducing the dose of warfarin on initiation of therapy with amiodarone, a detailed relationship between the maintenance dose of this antiarrhythmic and the magnitude of this drug interaction with long-term treatment has not been defined.

Therefore, this study was conducted to more completely characterize the drug interaction between amiodarone and warfarin over a longer period of time in a larger patient population and to determine if the magnitude of this interaction is dependent on the maintenance dose of amiodarone. Our results are germane to clinicians confronted with this drug/drug interaction and may aid them in the adjustment of long-term warfarin therapy.


   Materials and Methods
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 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Between March 1, 1992, and February 28, 1998, records at the University of Illinois at Chicago were screened for patients receiving concomitant amiodarone and warfarin therapy. Patients were included in the analysis if oral amiodarone was added to existing warfarin therapy and the combination of the two drugs was continued for at least 1 year. Patients receiving other drugs known either to prolong the prothrombin time (PT) or INR or to interact with warfarin were subsequently excluded from the analysis. Each patient’s medical record was examined, and the following data were collected: age, gender, race, indications for receiving amiodarone and warfarin, underlying organic heart disease (defined as the presence of hypertension, coronary artery diseases, and/or valvular disease), left ventricular ejection fraction, INR, concomitant drug therapy, and dosing regimens of amiodarone and warfarin. Patients were followed up from the initiation of concomitant therapy with amiodarone and warfarin. Follow-up was continued for a period of 1 year.

The warfarin dose was adjusted as necessary to maintain a therapeutic INR, which was defined in the majority of patients as an INR of 2 to 3. In a small subset of patients, however, the INR was maintained between the ranges of 2.5 to 3.5 and 1.5 to 2.5 for valvular replacement and dilated cardiomyopathy indications, respectively. On initiation of amiodarone, INRs were generally monitored every week for 1 month, and then on a monthly basis thereafter.

Amiodarone therapy was routinely initiated in the hospital with the administration of an oral loading dose of 800 to 1,600 mg/d for 1 week. Patient medications were then gradually tapered to maintenance doses on an ambulatory basis. In the absence of an implantable cardioverter-defibrillator, patients with recurrent, sustained ventricular tachycardia or ventricular fibrillator received a maintenance dose of 400 mg/d. A maintenance dose of 200 mg/d was used in patients with atrial fibrillation, atrial flutter, nonsustained ventricular tachycardia, or sustained ventricular tachycardia with an implantable cardioverter-defibrillator. Further reductions in the maintenance dose of amiodarone were made depending on the patient’s clinical response. This study was approved by the University of Illinois at Chicago Institutional Review Board.

Statistical Analysis
An analysis of variance with a post hoc Bonferroni test was used to compare the mean warfarin doses at baseline and during concomitant therapy with amiodarone. At each clinic visit, the patient’s dose of amiodarone and corresponding dose of warfarin was noted over the study period. From this data set, the mean doses of amiodarone and warfarin were calculated and linear regression was used to examine the correlation between them. The relationships between age, weight, gender, or left ventricular ejection fraction and the mean maximum percentage reduction in the warfarin dose were also analyzed by linear regression. Maximum percent reduction of warfarin for each patient and at each dose of amiodarone was calculated. Comparisons of mean maximum percentage reductions in the warfarin dose observed during therapy with amiodarone were performed using the Student’s t test. The level of statistical significance was defined as a p value < 0.05; all data are expressed as mean ± SD.


   Results
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 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
A total of 43 patients (26 male, 17 female; 62 ± 12 years of age) met the inclusion criteria and were included in the analysis. Amiodarone was used for the treatment of atrial fibrillation and/or atrial flutter in 33 patients, sustained or nonsustained ventricular tachycardia in 9 patients, and paroxysmal atrial tachycardia in 1 patient. Patients received long-term warfarin treatment for the following indications: atrial/flutter fibrillation (23 patients), prosthetic valve (9 patients), dilated cardiomyopathy (8 patients), left ventricular thrombus (2 patients) and recurrent deep venous thrombosis (1 patient). Thirty-two of the 43 patients had organic heart disease, and 3 patients had an implantable cardioverter-defibrillator. Of these, 24 patients had hypertensive disease (10 patients had concomitant coronary artery disease, and 4 patients had concomitant valvular disease), 4 patients had coronary artery disease (1 patient had concomitant valvular disease), and 4 patients had valvular disease alone.

Prior to initiation of therapy with amiodarone, the mean warfarin dosage and INR were 5.2 ± 2.6 mg/d and 2.02 ± 0.73, respectively. The mean dosage of amiodarone at baseline was 909 ± 456 mg/d. By the end of the first week, the mean dosage of amiodarone decreased to 327 ± 186 mg/d (Fig 1 ). After this time period, the mean dose of amiodarone continued to gradually decrease, with the average daily dose at the end of the 1-year study period being 246 ± 83 mg.



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  		Figure 1.. Mean INR and doses of amiodarone and warfarin. The mean ( ± SD) dose of amiodarone and the corresponding mean dose of warfarin along with the mean INR over the year study period are shown. The abrupt drop in the dose of amiodarone reflects the transition from the loading dose to a maintenance dose. Note the divergence of the curves at the monthly intervals; this is representative of continual attempts to lower the long-term maintenance dose of amiodarone in patients in stable condition (and minimize potential or real side effects) and the corresponding need to continually adjust (increase) the dose of warfarin to result in a therapeutic INR.

 
From baseline, the warfarin dose steadily decreased during the first 7 weeks of concurrent therapy with amiodarone (Fig 1 ). At the end of the first and second weeks, the mean warfarin dosage was 4.3 ± 2.7 mg/d and 3.5 ± 2.3 mg/d, respectively. After 4 weeks and 7 weeks, the mean daily dosage of warfarin significantly declined to 3.3 ± 1.5 mg and 2.9 ± 1.7 mg, respectively (p < 0.001 vs baseline). The magnitude of the interaction between amiodarone and warfarin peaked at 7 weeks, with a 44% mean maximum reduction in the warfarin dose being required by the study population. Following this time period, patients’ warfarin requirements gradually increased, with the mean daily dosage at the end of 1 year being 4.2 ± 1.7 mg. The mean maximum percentage reduction in warfarin was not significantly influenced by the patient’s age, race, weight, gender, or left ventricular ejection fraction.

Although a therapeutic INR was maintained throughout the study period (Fig 1) , minor bleeding, characterized by either nose or gum bleeding, occurred in five patients (12%). No major hemorrhagic episodes were observed in the study population.

As expected, the 400 mg/d and 200 mg/d dosages of amiodarone were most commonly used; there were 253 observations (ie, visits) at the 400 mg/d dosage, 39 observations at the 300 mg/d dosage, 288 observations at the 200 mg/d dosage, and 24 observations at the 100 mg/d dosage. A strong inverse correlation between the dose of amiodarone and mean dose of warfarin was observed (r2 = 0.94, p < 0.05; Fig 2 ). As the maintenance dosage of amiodarone decreased from 400 to 100 mg/d, the mean daily dosage of warfarin correspondingly increased from 3.2 ± 0.1 to 3.9 ± 0.2 mg. Based on these findings, 38 ± 1.7%, 36 ± 4.4%, 31 ± 1.9%, or 25 ± 4.4% reductions in the daily warfarin dose were necessary for patients receiving amiodarone maintenance dosages of 400, 300, 200, or 100 mg/d, respectively.



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  		Figure 2.. Relationship between the dose of amiodarone and the dose of warfarin. The mean ( ± SD) dose of warfarin is shown at each dosage level of amiodarone used for the cohort. There is a strong inverse relationship (r2 = 0.94).

 

   Discussion
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 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
Amiodarone causes a substantial decrease in the dose of warfarin required to achieve a therapeutic INR in all patients receiving this drug combination. Commercially, warfarin is available as a racemate of the (-)-S- and (+)-R- enantiomers; the (-)-S- enantiomer is about five times more potent as an anticoagulant.19 20 The (-)-S- and the (+)-R- enantiomers are stereoselectively metabolized by hepatic isozymes CYP2C9 and CYP1A2, respectively. Amiodarone inhibits the activity of both of these P450 enzymes19 20 .

Therefore, the ability of amiodarone to block the biotransformation of warfarin, primarily the (-)-S-enantiomer, to inactive metabolites is responsible for the enhanced anticoagulant effect observed in patients receiving both drugs.

Although it is widely recognized that amiodarone potentiates the anticoagulant effects of warfarin, the time course and magnitude of this clinically significant drug interaction has not been thoroughly examined or fully characterized. Previously, most of the descriptions of the interaction between these two agents were derived from isolated case reports and small studies.11 12 13 14 15 16 17 18 The most frequently cited of these studies was conducted by Kerin et al11 in 1988. This was a retrospective review of eight patients receiving concomitant amiodarone and warfarin therapy who were followed up for a period of 8 weeks. All patients received identical IV and oral loading doses of amiodarone followed by a maintenance dosage of 200 to 400 mg/d. After initiation of the amiodarone therapy, a 44% mean maximum increase in PT was observed, and occurred during the first week in five patients and during the second week in the other three patients. This increase in PT necessitated a 35% mean reduction in the warfarin dose. In a larger trial by Almog et al,18 30 patients (17 of whom had amiodarone added to a stable warfarin regimen) receiving both warfarin and amiodarone were analyzed. There was a significant (inverse) correlation between serum concentration of amiodarone and the dose of warfarin required to maintain a therapeutic PT. The authors recommended a 50% reduction in the dosage of warfarin for 400 mg/d of amiodarone and 35% reduction for 200 mg/d. The results of these two studies are consistent with those reported here; in addition, we decided to follow up all patients over a 1-year period to reasonably ensure that steady-state amiodarone concentrations were achieved.

In examining the mean dose of amiodarone that our patient population received over time, the abrupt reduction that occurred during the first 2 weeks of therapy reflects the transition from the initial loading dose to a maintenance dose regimen. Although the largest decline in the dose of warfarin occurred in the first 2 weeks of concurrent therapy, the full extent of the interaction took 6 to 8 weeks. The gradual decrease in the dose of amiodarone that was observed thereafter was representative of the effort that is often made to reduce the dose of amiodarone in order to minimize the development of adverse effects while still maintaining efficacy (Fig 1) . The declining trend in the dose of amiodarone occurred in concert with a corresponding gradual increase in the dose of warfarin needed to achieve a therapeutic INR. In fact, the mean dose of warfarin returned to near that of baseline values at the end of the 12-month study period. In practical terms, as the maintenance dose of amiodarone is reduced during long-term therapy, the corresponding dose of warfarin will need to be chronically adjusted and the INR will require continual monitoring in order to maintain a therapeutic level of anticoagulation.

Because of the observational nature of this study, not all patients received each possible dose of amiodarone; each patient did not contribute equally to the correlation. Nonetheless, analysis of the data demonstrated a strong inverse relationship between the mean dose of warfarin and the dose of amiodarone. This relationship could be used to assist clinicians with the selection of appropriate doses of warfarin for patients who are concurrently receiving different doses of amiodarone. For those patients in whom amiodarone is added to a stable warfarin regimen, we recommend an initial, empiric reduction in the dose of warfarin of about one third. Subsequently on a long-term basis, one can anticipate the need to reduce the dose of warfarin by approximately 40% when using a maintenance amiodarone dosage of 400 mg/d. Thereafter, as the dosage of amiodarone is decreased in 100 mg/d increments, an additional 5% reduction (relative to baseline) in the dose of warfarin necessary to achieve on INR of 2 to 3 will be necessary.

In conclusion, the magnitude of the interaction between amiodarone and warfarin appears to be highly dependent on the maintenance dose of amiodarone. Because of the inverse correlation observed between the doses of these commonly utilized agents, warfarin dosing guidelines can be developed based on the maintenance dose of amiodarone. By incorporating these guidelines into clinical practice, the initiation and maintenance of therapeutic warfarin therapy can be facilitated in patients receiving amiodarone therapy, and adverse sequelae of this significant interaction may be minimized.


   Footnotes
 
Abbreviations: INR = international normalized ratio; PT = prothrombin time

Presented in part at the American College of Cardiology 47th Annual Scientific Session, Atlanta, GA, March 29 to April 1, 1998.

Received for publication March 14, 2001. Accepted for publication May 29, 2001.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

  1. Roy, D, Talajic, M, Dorian, P, et al (2000) Amiodarone to prevent recurrences of atrial fibrillation. N Engl J Med 342,913-920[Abstract/Free Full Text]
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  3. Herre, JM, Sauve, MJ, Malone, P, et al (1989) Long-term results of amiodarone therapy in patients with recurrent sustained ventricular tachycardia or ventricular fibrillation. J Am Coll Cardiol 13,442-449[Abstract]
  4. Roberts, SA, Viana, MA, Nazari, J, et al (1994) Invasive and noninvasive methods to predict the long-term efficacy of amiodarone: a compilation of clinical observations using meta-analysis. Pacing Clin Electrophysiol 17,1590-1602[CrossRef][Medline]
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  6. Hohnloser, SH, Klingenheben, T, Singh, BN (1994) Amiodarone-associated proarrhythmic effects: a review with special reference to torsades de pointes tachycardia. Ann Intern Med 121,529-535[Abstract/Free Full Text]
  7. . for the Grupo de Estudio de la Sobrevida en la Insufficiency Cardiaca en Argentina (GESICA)Doval, HC, Nul, DR, Grancelli, HO, et al (1994) Randomized trial of low-dose amiodarone in severe congestive heart failure. Lancet 344,493-498[CrossRef][ISI][Medline]
  8. . for the Survival Trial of Antiarrhythmic Therapy in Congestive Heart FailureSingh, SN, Fletcher, RD, Fisher, SG, et al (1995) Amiodarone in patients with congestive heart failure with asymptomatic ventricular arrhythmias. N Engl J Med 333,77-82[Abstract/Free Full Text]
  9. . for the European Myocardial Infarct Amiodarone Trial (EMIAT) InvestigatorsJulian, DG, Camm, AJ, Frangin, G, et al (1997) Randomized trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. Lancet 349,667-674[CrossRef][ISI][Medline]
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