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Comment and Response |

Why Physicians Favored Lipitor Over Simvastatin

David L. Keller, MD1
[+] Author Affiliations
1Providence Medical Group, Torrance, California
JAMA Intern Med. 2013;173(15):1473. doi:10.1001/jamainternmed.2013.7747.
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To the Editor In their commentary on generic drug use, Alldredge and Kayser1(p233) state the following:That statement is an unfair criticism of physicians and conflicts with the expressed views of the Food and Drug Administration (FDA). On June 8, 2011, the FDA issued a safety warning concerning simvastatin2 in which physicians were advised to discontinue the use of simvastatin, 80 mg (except in patients who had already been taking it safely for over 1 year). For patients taking amlodipine, the FDA warned against prescribing more than 20 mg of simvastatin, and for patients taking diltiazem or verapamil, the dose of simvastatin was limited to 10 mg. These safety warnings were based on reports of adverse events including serious myopathy caused by simvastatin, 80 mg, and by lower doses of simvastatin when combined with widely prescribed calcium channel blockers. As a result, physicians were left with a maximum safe simvastatin dose of 40 mg, which lowers low-density lipoprotein cholesterol level by approximately 40%, whereas atorvastatin, 80 mg, lowers low-density lipoprotein cholesterol level by approximately 55%.3 The FDA has not deemed it necessary to issue similar safety restrictions on the use of atorvastatin, which may explain why physicians favored Lipitor over generic simvastatin in 2011.

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August 12, 2013
Brian K. Alldredge, PharmD; Steven R. Kayser, PharmD
1Department of Clinical Pharmacy, School of Pharmacy, University of California, San Francisco
JAMA Intern Med. 2013;173(15):1473. doi:10.1001/jamainternmed.2013.7701.
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Begging the question
Posted on August 14, 2013
David Louis Keller
PMG
Conflict of Interest: None Declared
Your reply to my letter implies that physicians could not have been aware of any problems with simvastatin before the first FDA warning in 2010. In fact, many physicians were well aware of the theoretical potential for problems with hepatic excretion of this drug due to multiple severe interactions, and patients themselves complained of myalgias which went away when they were switched to Lipitor. In my mind, there was little doubt of these facts long before the FDA finally acted, which is why this physician, for one, prescribed Lipitor for those patients who could obtain it and might benefit by switching to it from simvastatin. Less is more when discussing LDL levels, but not when it comes to CPK levels and the risk of rhabdomyolysis.
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