SINM PhyzioType^TM System: Statin-Induced Neuro-Myopathy

DIABETES + CVD, Reduction of Cardio-metabolic Risk by Lipid-lowering: Statins

The SINM PhyzioType System provides the physician with DNA-guided efficacy predictions for aggressive lipid lowering and risk profiles for neuromuscular side effects of atorvastatin, simvastatin, and rosuvastatin. The information can be employed prognostically before prescribing statin therapy or diagnostically to categorize neuro-myopathy in those statin patients already evidencing neurological or muscular symptoms and seeking remedial treatment. The SINM PhyzioType System consists of 4 tests predicting LDL lowering and HDL raising efficacy, and innate side-effect risk for myalgia and CK activity elevation (mopathy), in response to statins on a class-wide and drug-specific basis. A patent on the SINM PhyzioType product is pending as an application.

Statin Induction + Neuro-Myopathy (SINM), the balance of potency and safety, is the main clinical management challenge of these drugs, particularly in diabetes where treatment targets are aggressive requiring LDL cholesterol levels below 100 mg/dl. In medical practice, Neuro-myopathy presents as a constellation of neuromuscular side effects. Clinical symptoms include myalgia (muscle aches, cramps, weakness) and myopathy (muscular injury monitored by serum elevation of muscle enzymes). Neuro-myopathy is more frequent at the higher doses required for treating advanced cardiovascular disease and varies in extent between individual statins and from patient to patient. Therefore, prescribing the most potent statin on an individual basis is critical as well to avoid maximal doses. Statin usage is ultimately limited by toxicity. Neuro-myopathy is disabling to 10-20% of patients on statins, requires alteration of therapy, burdens healthcare with management costs, and reduces compliance. Only 50% of patients remain on statins 6 months after initiation of therapy.

Statins are the most prescribed drugs in the world. Statins are the most effective medications for managing elevated concentrations of low-density lipoprotein cholesterol (LDLc). These drugs offer effective strategies to reduce cardiovascular disease and have been documented to reduce morbidity in both coronary heart disease patients and in previously healthy subjects. There are more than 40 million Americans with high cholesterol of which 17 million are currently prescribed the statin class of cholesterol lowering drugs, a market currently exceeding $14 Billion in the U.S. alone with 190 million prescriptions written in 2008, up from 98 million in 2002.

All statin labels bear clear warnings of muscle injury and motor disability as a consequence of treatment. For example the atorvastatin label states: “Myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CK) values…should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CK…Atorvastatin therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected.”