The Medical Letter on Drugs and Therapeutics
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New Simvastatin Dosing Recommendations

The FDA has announced changes in the labeling of simvastatin to reduce the risk of myopathy. These changes include limiting the use of the 80-mg maximum dose to patients who have been taking it for 12 months or more without evidence of myopathy and new recommendations for use of simvastatin with other drugs.1 Simvastatin is available alone (Zocor, and others) and in combination with ezetimibe (Vytorin) and with niacin (Simcor).

MYOPATHY — The risk of myopathy with simvastatin is closely related to the dose of the drug and even more closely to its concentration in serum.2 In a 7-year randomized trial (SEARCH) in 12,064 patients, the incidence of myopathy (unexplained muscle pain or weakness and a CK >10 times the upper limit of normal) was 0.9% in patients taking 80 mg of simvastatin daily and 0.03% in those taking 20 ... more      

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