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Dronedarone-digoxin interaction in PALLAS: A foxglove connection?

ElMaghawry M, Farouk M - Glob Cardiol Sci Pract (2015)

Bottom Line: In the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, dronedarone use was associated with an excess risk of stroke, cardiovascular death and hospitalizations.However, an increased level in the serum digoxin level was observed in the dronedarone arm, as it is a potent inhibitor of the P-glycoprotein transport system.The PALLAS subanalysis suggests that digoxin-dronedarone interaction was responsible for the higher arrhythmic death rate observed in the trial.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Aswan Heart Centre, Kasr ElHajjar, Aswan, Egypt.

ABSTRACT
In the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, dronedarone use was associated with an excess risk of stroke, cardiovascular death and hospitalizations. However, an increased level in the serum digoxin level was observed in the dronedarone arm, as it is a potent inhibitor of the P-glycoprotein transport system. The PALLAS subanalysis suggests that digoxin-dronedarone interaction was responsible for the higher arrhythmic death rate observed in the trial. These data are consistent with several other studies that demonstrate the potential hazard of the use of digoxin in heart failure and/or atrial fibrillation. One must consider other safer alternatives before prescribing digoxin in atrial fibrillation patients.

No MeSH data available.


Related in: MedlinePlus

Dronedarone molecular structure in comparison to amiodarone. Note there are no iodine moieties in dronedarone.
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Related In: Results  -  Collection


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fig1: Dronedarone molecular structure in comparison to amiodarone. Note there are no iodine moieties in dronedarone.

Mentions: Antiarrhythmic drug therapy remains the cornerstone for the management of atrial fibrillation (AF). Despite being not FDA approved for the use in atrial fibrillation, amiodarone is the most commonly used medication to maintain sinus rhythm in patients with AF. Dronedarone is the first of a group of drugs that have been designed to resemble amiodarone with fewer non-cardiovascular side effects. It is similar in structure to amiodarone with the addition of a methylsufonamide group and absence of iodine moieties (Figure 1).1 In the trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients with Atrial Fibrillation/Atrial Flutter (ATHENA), dronedarone use in patients with non-permanent AF was associated with significant reduction in the rate of composite end point of death from cardiovascular causes and hospitalization due to cardiovascular events.2 The positive results of ATHENA incited investigators to further test the effect of dronedarone on permanent AF patients. In the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS), dronedarone use was associated with an excess risk of stroke, cardiovascular death and hospitalizations.3 However, an increased level in the serum digoxin level was observed in the dronedarone arm. A recent analysis, published in Circulation Arrhythmia and Electrophysiology Journal examined whether the dronedarone–digoxin interaction might explain these adverse outcomes.4


Dronedarone-digoxin interaction in PALLAS: A foxglove connection?

ElMaghawry M, Farouk M - Glob Cardiol Sci Pract (2015)

Dronedarone molecular structure in comparison to amiodarone. Note there are no iodine moieties in dronedarone.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4374098&req=5

fig1: Dronedarone molecular structure in comparison to amiodarone. Note there are no iodine moieties in dronedarone.
Mentions: Antiarrhythmic drug therapy remains the cornerstone for the management of atrial fibrillation (AF). Despite being not FDA approved for the use in atrial fibrillation, amiodarone is the most commonly used medication to maintain sinus rhythm in patients with AF. Dronedarone is the first of a group of drugs that have been designed to resemble amiodarone with fewer non-cardiovascular side effects. It is similar in structure to amiodarone with the addition of a methylsufonamide group and absence of iodine moieties (Figure 1).1 In the trial to Assess the Efficacy of Dronedarone 400 mg BID for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients with Atrial Fibrillation/Atrial Flutter (ATHENA), dronedarone use in patients with non-permanent AF was associated with significant reduction in the rate of composite end point of death from cardiovascular causes and hospitalization due to cardiovascular events.2 The positive results of ATHENA incited investigators to further test the effect of dronedarone on permanent AF patients. In the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS), dronedarone use was associated with an excess risk of stroke, cardiovascular death and hospitalizations.3 However, an increased level in the serum digoxin level was observed in the dronedarone arm. A recent analysis, published in Circulation Arrhythmia and Electrophysiology Journal examined whether the dronedarone–digoxin interaction might explain these adverse outcomes.4

Bottom Line: In the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, dronedarone use was associated with an excess risk of stroke, cardiovascular death and hospitalizations.However, an increased level in the serum digoxin level was observed in the dronedarone arm, as it is a potent inhibitor of the P-glycoprotein transport system.The PALLAS subanalysis suggests that digoxin-dronedarone interaction was responsible for the higher arrhythmic death rate observed in the trial.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Aswan Heart Centre, Kasr ElHajjar, Aswan, Egypt.

ABSTRACT
In the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) study, dronedarone use was associated with an excess risk of stroke, cardiovascular death and hospitalizations. However, an increased level in the serum digoxin level was observed in the dronedarone arm, as it is a potent inhibitor of the P-glycoprotein transport system. The PALLAS subanalysis suggests that digoxin-dronedarone interaction was responsible for the higher arrhythmic death rate observed in the trial. These data are consistent with several other studies that demonstrate the potential hazard of the use of digoxin in heart failure and/or atrial fibrillation. One must consider other safer alternatives before prescribing digoxin in atrial fibrillation patients.

No MeSH data available.


Related in: MedlinePlus