Medication Management for Patients on Simvastatin (Zocor®)
Practitioner Newsletter - Issue 4, 2011
In June, the FDA released new recommendations regarding the use of simvastatin due to an increased risk of muscle damage with high doses (80 mg). These recommendations are a result of the FDA’s review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial, as well as ongoing safety reviews. The SEARCH trial was conducted over seven years and compared simvastatin 80 mg to 20 mg in a randomized, double-blind trial. There was no significant difference in the incidence of major vascular events between simvastatin 80 mg group (24.5%) and 20 mg group (25.7%) (p=0.10), but a higher percentage of patients in the 80 mg group developed myopathy compared to the 20 mg group (0.9% vs. 0.02%). Older age, female sex, and certain genetic variations were associated with higher risks for myopathy and rhabdomyolysis. Additionally, the incidence of myopathy and rhabdomyolysis were highest in the first 12 months of treatment.
Major Takeaways
- Patients should continue simvastatin 80 mg daily only if they have been taking this dose for at least 12 months and have not experienced signs or symptoms of muscle toxicity.
- Do not start new patients on simvastatin 80 mg.
- If a patient does not meet his or her LDL-C goal on simvastatin 40 mg, further LDL-C lowering should be attempted with alternative treatment(s) that provides greater LDL-C lowering.
- Atorvastatin (Lipitor) is anticipated to be available as a generic (and a Tier 1 copay) in late 2011 or early 2012.
- Use Table B for converting between simvastatin and other statins at equi-potent doses.
- Follow the dose limitations for simvastatin-containing products as noted in Table A. If a patient requires a medication that interacts with simvastatin, switch them to a medication that has less potential for interaction.
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