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Published on: February 28, 2012
Amiodarone for the prevention of sudden cardiac death: a meta-analysis of randomized controlled trials
Jonathan P Piccini1, Jeffrey S Berger, Christopher M O'Connor
1Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center #31115, Durham, NC 27710, USA. jonathan.piccini@duke.edu
Insights
Amiodarone significantly reduces sudden cardiac death (SCD) and cardiovascular death in at-risk patients. While not improving overall mortality, it offers an alternative to implantable cardioverter defibrillators (ICDs) but carries risks of pulmonary and thyroid toxicity.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Not all patients at risk for sudden cardiac death (SCD) are candidates for or can access implantable cardioverter defibrillator (ICD) implantation.
- Conflicting data exist regarding amiodarone's efficacy and safety for SCD prevention.
Purpose of the Study:
- To conduct a meta-analysis of randomized controlled trials (RCTs) evaluating amiodarone versus placebo/control for SCD prevention.
- To assess the efficacy and safety of amiodarone in reducing SCD and cardiovascular death.
Main Methods:
- Meta-analysis of 15 randomized controlled trials.
- Inclusion of 8522 patients randomized to amiodarone or placebo/control.
- Statistical analysis of incidence rates and odds ratios for SCD, cardiovascular death, all-cause mortality, and specific toxicities.
Main Results:
- Amiodarone significantly decreased the incidence of SCD (7.1% vs. 9.7%; OR 0.71) and cardiovascular death (14.0% vs. 16.3%; OR 0.82).
- Absolute risk reduction in all-cause mortality was 1.5% but did not reach statistical significance (P = 0.093).
- Amiodarone therapy increased the risk of pulmonary (OR 1.97) and thyroid (OR 5.68) toxicity.
Conclusions:
- Amiodarone is a viable alternative to ICDs for SCD prevention, reducing SCD risk by 29% and cardiovascular death by 18%.
- Amiodarone therapy is neutral regarding all-cause mortality.
- Increased risks of pulmonary and thyroid toxicity necessitate careful patient monitoring.
Aims:
Not all patients at risk for sudden cardiac death (SCD) are eligible for, or have access to implantable cardioverter defibrillator (ICD) implantation. There are conflicting data regarding the efficacy and safety of amiodarone for the prevention of SCD.
Methods And Results:
We conducted a meta-analysis of all randomized controlled trials examining the use of amiodarone vs. placebo/control for the prevention of SCD. We identified 15 trials, which randomized 8522 patients to amiodarone or placebo/control. Amiodarone decreased the incidence of SCD [7.1 vs. 9.7%; OR 0.71 (0.61-0.84), P < 0.001] and cardiovascular death (CVD) [14.0 vs. 16.3%; OR 0.82 (0.71-0.94), P = 0.004]. There was a 1.5% absolute risk reduction in all-cause mortality which did not meet statistical significance (P = 0.093). Amiodarone therapy increased the risk of pulmonary [2.9 vs. 1.5%; OR 1.97, (1.27-3.04), P = 0.002], and thyroid [3.6 vs. 0.4%; OR 5.68, (2.94-10.98), P < 0.001] toxicity.
Conclusion:
Amiodarone reduces the risk of SCD by 29% and CVD by 18%, and therefore, represents a viable alternative in patients who are not eligible for or who do not have access to ICD therapy for the prevention of SCD. However, amiodarone therapy is neutral with respect to all-cause mortality and is associated with a two- and five-fold increased risk of pulmonary and thyroid toxicity.
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