Pharmacotherapy Newsletter

Volume 1, Issue 46, 11/30/2009

Question

How do you identify and classify statin (HMG-CoA reductase inhibitor) associated muscle aches and pains?

Answer

There hasbeen some confusion over the years on how to identify or label muscle relatedproblems while taking statins or HMG Co-A reductase inhibitors.  A review of the literature would show ahigh degree of variability in the definitions for myopathy, thus making it verydifficult to determine the true incidence across multiple statins and clinicalsituations.(1-3)  This variabilityin definition/categorization also extends to the more severe form of myopathy,rhabdomyolysis.  For example, theFood and Drug Administration (FDA) defines rhabdomyolysis as a creatinephosphokinase (CPK or CK) greater than 50 times normal (or greater than 10,000IU/L) with organ damage, usually renal compromise.  Whereas, the National Cholesterol Education Program (NCEP)Advisory Panel defines it as a CK greater than 10 times the upper limit ofnormal (ULN) with renal compromise.(3-5) Recognizing this inconsistency in the literature, the National LipidAssociation's (NLA) Statin Safety Task Force put forth the followingdefinitions to better guide clinicians as well as to help establish consistencyamong clinical trials. 

The complete answer tothis question comes with an algorithm for determining the type ofstatin-induced muscle complication.

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