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To the Editor: Dr Nissen’s statements regarding the safety of an 80-mg dose of simvastatin in his editorial¹ warrant comment. More than 50 000 patients have been studied in clinical trials with simvastatin, and the drug has been shown to reduce the risk of cardiovascular morbidity and mortality in high-risk patients.² Based on evidence that greater LDL-C level lowering is associated with improved cardiovascular outcomes, Merck (Whitehouse Station, NJ) extended the maximal dose of simvastatin from 40 mg to 80 mg. Nissen correctly states that Merck has previously published data indicating that the risk of myopathy with an 80-mg dose of simvastatin is higher than that with a 40-mg dose.³ This information has been available in the "Warning" section of the product circular since the introduction of the 80-mg dose in 1998. The incidence of myopathy in the A to Z trial⁴ is entirely consistent with these data.

Merck attempted to . . . [Full Text of this Article]

Yale B. Mitchel, MD
yale_mitchel@merck.com
Merck Research Laboratories
Rahway, NJ

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