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Adverse events with concomitant amiodarone and statin therapy
Alawi A Alsheikh-Ali1, Richard H Karas
1Department of Medicine, Division of Cardiology, Preventive Cardiology Center, Tufts-New England Medical Center, Boston, MA 02111, USA.
Preventive Cardiology
|April 30, 2005
Summary
Concurrent amiodarone use with statins like simvastatin, atorvastatin, and pravastatin was reviewed. Muscle toxicity was the most frequent adverse event (AE), particularly in elderly patients on multiple medications.
Area of Science:
- Pharmacology
- Drug Safety
- Clinical Therapeutics
Background:
- Statins are widely prescribed for hyperlipidemia.
- Amiodarone is an antiarrhythmic drug with known drug interaction potential.
- Concurrent use of statins and amiodarone may increase the risk of adverse events.
Purpose of the Study:
- To determine the percentage of statin-associated adverse event (AE) reports involving concurrent amiodarone use.
- To analyze specific organ systems affected by these drug combinations.
- To identify risk factors associated with these adverse events.
Main Methods:
- Review of adverse event reports submitted to the United States Food and Drug Administration (FDA).
- Analysis focused on simvastatin, atorvastatin, and pravastatin in conjunction with amiodarone.
- Evaluation of AEs in muscle, liver, pancreas, and bone marrow.
Main Results:
- Simvastatin showed a 1.0% AE rate with amiodarone, compared to 0.7% for atorvastatin (not significant).
- Pravastatin had a lower AE rate of 0.4% (p < 0.05 vs. simvastatin).
- Muscle toxicity was the most common AE (77%), occurring in elderly males (mean age 76) on multiple medications (mean 5).
Conclusions:
- Clinicians must monitor for muscle-related complaints in patients taking amiodarone and statins concurrently.
- Elderly patients on multiple medications are at higher risk.
- Consider statins not metabolized via cytochrome P450-3A4 in this patient population.