October 1, 1994Annals of Internal Medicine
Amiodarone-associated Proarrhythmic Effects: A Review with Special Reference to Torsade de Pointes Tachycardia
Why the study?
Does amiodarone therapy increase the incidence of proarrhythmic events such as torsade de pointes in patients with cardiac disease?
Population
Patients with cardiac disease, including 2878 patients from 17 studies treated for at least 6 months, and 31…
Comparison
Amiodarone therapy vs Placebo or none
Design
Review
Follow-up
at least 6 months
Authors
Discussion
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Overview
Amiodarone shows low proarrhythmic incidence in reviewed data; leaves open prospective confirmation in contemporary high-risk cohorts.
Key Points
- To evaluate the incidence of amiodarone-mediated aggravation of ventricular tachyarrhythmias and new-onset arrhythmias, specifically torsade de pointes, in cardiac patients.
- Searched MEDLINE over a 20-year period for articles reporting amiodarone-associated proarrhythmic events.
- Categorized literature into case reports, uncontrolled retrospective studies, and prospective controlled trials, including studies of patients with prior drug-induced torsade de pointes.
- Across 17 studies with at least 50 patients treated for 6 months (N=2878), proarrhythmic events occurred in 57 patients (2.0%), with torsade de pointes occurring in 0.7% (n=19).
- Across seven placebo-controlled monotherapy trials, zero proarrhythmic events were observed among amiodarone-treated patients.
- In 31 patients with prior drug-induced torsade de pointes, zero experienced recurrence during amiodarone therapy despite equivalent QTc interval prolongation.
Structured PICO
Does amiodarone therapy increase the incidence of proarrhythmic events such as torsade de pointes in patients with cardiac disease?
P
Population
Patients with cardiac disease, including 2878 patients from 17 studies treated for at least 6 months, and 31 patients with previous drug-mediated torsade de pointes.
I
Intervention
Amiodarone therapy
C
Comparator
Placebo (in 7 controlled trials) or none (in uncontrolled studies)
O
Outcome
Incidence of amiodarone-mediated aggravation of ventricular tachyarrhythmias or development of new arrhythmias, such as torsade de pointessafety
Amiodarone is associated with a remarkably low frequency of proarrhythmic events and torsade de pointes (<1.0%), supporting its safety profile in high-risk patients prone to sudden cardiac death.
Cite This Study
Stefan H. Hohnloser (1994) studied this question.