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What Would You Do?

Dosing Simvastatin: New 2011 FDA Recommendation

Click here for this case study, which was
emailed to you on March 8, 2012.

Author Answer

In early June 2011, the FDA issued a safety warning on simvastatin 80-mg dosing, stating that the 80-mg dose was associated with higher rates of myopathy and rhabdomyolysis compared with other statins. The 2011 FDA update lists several changes on drug-drug interaction with simvastatin, and lists maximum recommended doses when these agents are used simultaneously. Our patient, FR, is not on any of these interacting medications. The FDA update also states that the simvastatin 80-mg dose should be restricted to patients who have been taking this dose for 12 months or more, without signs/symptoms of muscle toxicity. Although our patient denies any complaints of muscle toxicity, he has been on the higher dose for less then 12 months, and the medication should be discontinued to avoid future issues. The recommendations also state that patients who do not achieve their LDL goal with simvastatin 40 mg should be changed to an alternative, more potent statin. A good example would be switching the patient to rosuvastatin 20 mg daily. Additionally, to achieve optimal triglyceride lowering, the PharmD could advise that a fibric acid, such as fenofibrate 48 mg daily, be added to the medication regimen. The fasting lipid panel will need to be rechecked 4 to 8 weeks after the medication changes are made.

Anna Markel Vaysman, PharmD, BCPS
Clinical Pharmacist, Clinical Assistant Professor
College of Pharmacy
University of Illinois at Chicago
Chicago, Illinois

Reader Response

My recommendation would be to replace the simvastatin 80 mg with atorvastatin 80 mg or rosuvastatin 40 mg. Patient is not at goal (LDL <100) with max dose of simvastatin, and the simvastatin 80-mg dose is risky for adverse effects.

C Simon, BS Pharm
Columbia, MO

Reader Response

For this patient, there are a couple of choices. Continue simvastatin 80 mg along with starting Niaspan and Zetia. Use a combination of Zetia and simvastatin (Vytorin 10/80) and Niaspan 500 mg per day. As always, diet and exercise control are key in managing hypercholesterolemia. Or, use Niaspan along with Tricor and discontinue simvastatin. Simvastatin along with fibrates is not recommended.

Romil Shah, PharmD
Pharmacy Manager
Rite Aid Pharmacy

Reader Response

Since Lipitor is also now available generically, I would recommend switching him to Lipitor 40 mg daily and rechecking labs in 3 months or so. I think his "numbers" could still use a little improvement, and although he has no complaints, he is at max dose of simvastatin.
Time for a change.

J Bullis, BS Pharm
Salisbury, MD

Reader Response

This patient is diabetic, so we need to target LDL <100 (preferably <70) as well as non-HDL since his TG are >200. I suggest changing simvastatin to rosuvastatin 20 mg plus ezetimibe 10 mg plus niacin.

Amer Hussien Saleh, BPharm, PharmD, BCNSP, BCPS