Pharmacotherapy Newsletter

Volume 1, Issue 47, 12/07/2009

Question

What is the incidence of statin (HMG-CoA reductase inhibitor) associated myopathy (myalgia or muscle pain), myositis (muscle breakdown) and rhabdomyolysis?

Answer

Statin associated myopathy is a common complaint of many patients.(1-3)  Most clinicians have encountered this side effect in every day clinical practice.  Since this problem appears to be a common occurrence in clinical practice, what is the incidence of this side effect?  Unfortunately, the answer to this is not so straight forward.  This is due to the variability in the statin associated myopathy definitions used by regulatory agencies, guidelines and in clinical trials.  For example, the Food and Drug Administration (FDA) defines rhabdomyolysis as a creatine phosphokinase (CPK or CK) greater than 50 times normal (or greater than 10,000 IU/L) with organ damage, usually renal compromise.  Whereas, the National Cholesterol Education Program (NCEP) Advisory Panel defines it as a CK greater than 10 time the upper limit of normal (ULN) with renal compromise.  Recognizing this inconsistency in the literature, the National Lipid Association's Statin Safety Task Force put forth a set of definitions to better guide clinicians as well as to help establish consistency among clinical trials.(1) 

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