Biomarkers for sensitive detection of statin-induced muscle toxicity

A method for determining whether a subject undergoing treatment with a lipid lowering drug is at risk to develop, or is suffering from muscle toxicity induced by the lipid lowering drug and/or one or more of its complications, wherein the one or more complications are selected from myalgia, myositis, myopathy, and rhabdomyolysis, the method comprising:

• (a) determining in a sample from said subject undergoing treatment with the lipid lowering drug the concentration(s) of one or more lipid(s), wherein the sample is whole blood, blood plasma, blood serum, muscle biopsy tissue, or urine, and wherein the one or more lipid(s) is (are) an eicosanoid selected from:
• 12-hydroxyeicosatetraenoic acid (HETE), 15-HETE, arachidonic acid (AA), 12-HEPE (hydroxyeicosapentaenoic acid), 14_15-DHET (dihydroxyeicosatrienoic acid) and 813 9-DHET;
• (b) comparing the concentration of the one or more lipid(s) to a control;
• and
• (c) determining whether the subject is at risk to develop, or is suffering from muscle toxicity induced by the lipid lowering drug and/or one or more of its complications, wherein (an) increased concentration(s) of one or more of 12-HETE, 15-HETE, AA, or 12-HEPE in said sample or decreased concentration(s) of one or more of 1413 15-DHET or 8139-DHET in said sample, when compared to the control, is (are) indicative of said subject suffering from said muscle toxicity induced by the lipid lowering drug and/or said complication(s), wherein the lipid concentration(s) is (are) determined by using mass spectrometry, and
• wherein if the concentration of the one or more of 12-HETE, 15-HETE, AA, or 12-HEPE is increased or the concentration of the one or more of 14_15-DHET or 8_9-DHET is decreased, as compared to the control, the method further comprises after step (c), a step of:
• i) reducing a statin dose;
• ii) stopping a statin treatment
• iii) changing to a different statin drug;
• or
• iv) changing to a different lipid lowering drug.