Dronedarone Brand Name– Multaq
What is Dronedarone
Dronedarone is an antiarrhythmic agent developed to have similar efficacy to amiodarone with an improved safety and tolerability profile.
However, dronedarone carries a boxed warning contraindicating its use in patients with NYHA Class IV heart failure, patients with symptomatic heart failure with recent decompensation, and in patients in atrial fibrillation who cannot be cardioverted into normal sinus rhythm; dronedarone use doubles mortality risk and/or serious adverse events in these populations.
In an unpublished trial comparing dronedarone to amiodarone, amiodarone had greater control of cardiac rhythm than dronedarone.
Data from this trial also indicate that dronedarone therapy results in a greater incidence of diarrhea while amiodarone therapy results in a higher incidence of thyroid dysfunction, significant bradycardia, and more pronounced QTc interval prolongation. Unlike other dronedarone trials, the ANDROMEDA trial enrolled high-risk patients with symptomatic heart failure and severe left ventricular systolic dysfunction. Interim safety analysis revealed an excess risk of death in the dronedarone group compared to placebo.
The increased mortality was predominately due to worsening heart failure.
Because of structural modifications made to dronedarone (removal of iodine moiety and addition of methane-sulfonamyl group), dronedarone has decreased lipophilicity, resulting in a shorter half-life (13—19 hours compared to 58 days for amiodarone), and lower tissue accumulation compared to amiodarone.
These characteristics of the dronedarone molecule are postulated to account for the improved safety profile seen with dronedarone; however, trials lasting longer than 12 months have not been conducted.
Dronedarone is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation. It should not be used in patients with permanent atrial fibrillation as this use is associated with an increased risk of death, stroke, and heart failure.
Dronedarone (Multaq) was approved by the FDA in July 2009.
Indications
- atrial fibrillation
For reduction in the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation
Side Effects
- abdominal pain
- anaphylactoid reactions
- angioedema
- arrhythmia exacerbation
- asthenia
- atrial flutter
- azotemia
- bradycardia
- coagulopathy
- diarrhea
- dysgeusia
- dyspepsia
- elevated hepatic enzymes
- heart failure
- hepatic encephalopathy
- hepatic failure
- hepatic necrosis
- hyperbilirubinemia
- hypokalemia
- hypomagnesemia
- hypothyroidism
- jaundice
- maculopapular rash
- nausea
- photosensitivity
- pneumonitis
- pruritus
- pulmonary fibrosis
- QT prolongation
- rash
- renal failure (unspecified)
- stroke
- torsade de pointes
- vasculitis
- vomiting
- weakness
Monitoring Parameters
- ECG
- serum creatinine
- serum magnesium
- serum potassium
Contraindications
- amiodarone-induced liver toxicity
- Amiodarone-induced lung toxicity
- apheresis
- Asian patients
- atrial fibrillation
- AV block
- bradycardia
- breast-feeding
- cardiomyopathy
- celiac disease
- children
- electrolyte imbalance
- females
- fever
- geriatric
- heart failure
- hepatic disease
- human immunodeficiency virus (HIV) infection
- hyperparathyroidism
- hypocalcemia
- hypokalemia
- hypomagnesemia
- hypothermia
- hypothyroidism
- hypovolemia
- infants
- long QT syndrome
- myocardial infarction
- neonates
- pheochromocytoma
- pregnancy
- QT prolongation
- rheumatoid arthritis
- sick sinus syndrome
- sickle cell disease
- sleep deprivation
- stroke
- systemic lupus erythematosus (SLE)
- torsade de pointes
Interactions
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