Biomarker For Improving Statin Therapy - Isis Project No 3542

Oxford researchers have identified a biomarker predictive of myopathy risk, which helps to improve the efficacy and safety of statin therapy for individual patients.

Marketing Opportunity

The World Health Organization states that about 200 million individuals have heart disease, stroke or diabetes worldwide. Currently, there are 25 million patients prescribed statins, accounting for a market of $25 billion (http://www.medicalnewstoday.com/articles/117071.php). Though the rare side effect of myopathy typically occurs in one in 10,000 patients of treatment per year, the risk increases about ten-fold with higher statin doses (e.g. when increasing dose from 40 mg to 80 mg simvastatin daily). Costs of treatment for myopathy are estimated at between $20,000 and $50,000 per patient, making mass screening highly desirable to avoid both treatment expense and potential lawsuits. This invention will be of great interest, therefore, to diagnostic testing companies, statin manufacturers and health insurers.

The Oxford Invention

Statins are widely used cholesterol-lowering drugs that substantially reduce the risk of cardiovascular events. Some patients, however, suffer the serious side effect of myopathy (muscle pain, deterioration and weakness), which can progress to rhabdomyolysis (severe muscle breakdown and kidney damage or failure). This myopathy risk varies between statins and increases with higher statin doses or concomitant use of certain drugs. The safety of statin therapy has become a concern for clinicians and patients in two respects – the safety of using higher doses to achieve lower levels of low-density lipoprotein (LDL) cholesterol, and the safety of available statins at different doses for specific individuals (Lancet Vol 370, 24th Nov 2007).

The Clinical Trial Service Unit (CTSU), Oxford has identified genetic markers that allow patients at higher risk of myopathy to be identified before treatment regimens are chosen. Thus effective screening assays can be made to enable safer clinical practice and better healthcare decisions.

Figure 1. Results of tests for a trend in the association between myopathy and each SNP Measured in the Genome-wide Association Study.

NEJM Vol 359, No 8, 21st Aug 2008. The SEARCH group used 300,000 markers (and additional fine-mapping) in trials involving 12,000 and 20,000 participants, and found that the rs4364657 SNP in the SLCO1B1 gene is highly associated with myopathy (P=4x10-9). This is correlated with the non-synonymous (amino acid altering) rs4149056 SNP: more than 60% of the myopathy cases could be attributed to the rs4149056 SNP C allele (prevalence of 15% in the population).

Patent Status

This work is the subject of a patent application, and Isis is keen to talk to companies interested in developing the large commercial opportunity. Please contact the Isis Project Manager.

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