Biomarker Identified for Statin Induced Myopathy

A diagnostic test based on a biomarker would allow an individual's statin treatment to be personalized based on their genetic risk of myopathy.

Myopathy is a rare side effect of statin use that results in muscle pain and weakness. A genetic test could offer both potential cost- savings and healthcare benefits by identifying individuals who could safely benefit from low-cost generic statins versus individuals who could benefit from the newer more potent, but expensive, branded statins.

Two recent studies carried at Oxford University (Oxford, UK), have examined whether more intensive treatment using statin drugs to lower levels of bad cholesterol leads to even greater reductions in the risk of a heart attack or stroke than with regular statin doses. The biomarker, a variation in the DNA code of a gene called SLC01B1, was responsible for 60% of the myopathy cases in people taking high dose statin therapy. SLC01B1 regulates the uptake of statins into the liver and the genetic variant seems to affect its function, causing higher levels of the statin to be present in the blood. Isis Innovation, (Oxford, UK), a wholly-owned subsidiary of Oxford University, has filed a patent application based on this discovery and is looking for commercial partners to develop this test.

The studies demonstrated the potential healthcare benefits of intensive statin use in people at risk of heart disease. This treatment resulted in a 15% further reduction in cardiovascular events and deaths compared to standard statin therapy. However, raising blood concentrations with higher statin doses, particularly with generic statins also increases the rate of myopathy. The authors advise that it may be safer to use low doses of more potent statins rather than to increase the dose of less potent statins in individuals at risk of myopathy. The studies were published on November 9, 2010, in the Lancet.

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