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Concurrent use of statins and amiodarone
1Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Epidemiology, Silver Spring, Maryland 20903, USA.
Insights
Nearly half of patients on amiodarone also received a statin, increasing myopathy risk. Clinicians should monitor patients on concurrent amiodarone and statin therapy, especially avoiding simvastatin doses over 20 mg daily.
Area of Science:
- Pharmacology
- Drug Interactions
- Cardiovascular Medicine
Background:
- Concurrent use of statins and amiodarone is a clinical concern due to potential drug interactions.
- Published case reports highlight the risk of rhabdomyolysis associated with this drug combination.
Observation:
- A retrospective analysis of a 2006 prescription claims database was conducted.
- The study examined concurrent prescriptions of statins (HMG CoA reductase inhibitors) and amiodarone.
Findings:
- A significant proportion (44%) of amiodarone patients also received a statin concurrently.
- Atorvastatin (23.5%) and simvastatin (13.3%) showed the highest concurrency rates with amiodarone.
- Higher simvastatin doses (20 mg and 40 mg) were more frequently prescribed concurrently with amiodarone.
Implications:
- Clinicians must vigilantly monitor patients on combined amiodarone and statin therapy for myopathy.
- Addition of amiodarone or statin dose adjustments necessitate a drug regimen review.
- Avoid prescribing simvastatin doses exceeding 20 mg/day to patients concurrently taking amiodarone.
Objective:
To estimate the concurrent use between statins and amiodarone in context with published case reports of drug-interaction-induced rhabdomyolysis.
Design:
Retrospective analysis of a longitudinal prescription claims database for concurrent prescriptions of statins and amiodarone dispensed during 2006.
Patients, Participants:
The study population includes an unprojected annual number of patients who filled a prescription for an HMG CoA reductase inhibitor or simvastatin-containing products or lovastatin-containing products or Lipitor (atorvastatin) or Caduet (amlodipine/atorvastatin) concurrently with brand and generic forms of amiodarone during 2006. The concurrency analysis was used to provide context for published case reports of rhabdomyolysis/myopathy related to simvastatin and amiodarone concurrent use.
Main Outcome Measure:
Episodes of concurrent use between statins and amiodarone.
Results:
Findings from this analysis indicate noteworthy amiodarone and statin concurrency (44%) when based on amiodarone patient volume. Atorvastatin had the greatest level of concurrency (23.5%) with amiodarone followed by simvastatin (13.3%). Proportionality based on amiodarone patient volume shows a greater level of concurrency with 20 mg (6%) and 40 mg (5.5%) simvastatin strengths compared with other simvastatin strengths.
Conclusion:
Clinicians should be vigilant in monitoring the regimens of patients prescribed a statin with drugs that may increase the risk of myopathy. In particular, since nearly half of the patients prescribed amiodarone may also be prescribed a statin, then addition of amiodarone or changes in statin dose should trigger a drug regimen review and patient level monitoring. Clinicians should avoid simvastatin doses greater than 20 mg per day in patients taking amiodarone.
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