Drug Target and Molecular Test for Statin Efficacy

Case Number CH-059

Inventors: Ronauld Krauss, MD

Patent No. Title Issue Date Country
Pending Drug Target and Molecular Test for Statin Efficacy   United States

Abstract
This invention provides methods for assessing a subject's responsiveness to a 3-hydroxy-3-3methylglutaryl coenzyme A reductase (HMGCR) inhibitor therapy, and selection of a HMGCR inhibitor therapy based upon such methods, as well as methods for identifying agents that modulate HMGCR activity, while avoiding elevation of the statin-resistant isoform of HMGCR.

Elevated cholesterol levels are an important risk factor for cardiovascular disease, which is a leading cause of death in the industrialized world. Controlling the risk factors for cardiovascular disease is a key preventative and therapeutic target in reducing this high mortality rate. Well-established risk factors for cardiovascular disease include elevated plasma levels of cholesterol (hypercholesterolemia), triglycerides, homocysteine, and certain lipoproteins, such as low-density lipoprotein (LDL) cholesterol.

Because of its role in cholesterol synthesis, HMGCR inhibitors have been of particular interest in controlling cholesterol levels. Statins, one of the most widely prescribed classes of drugs in the US, directly inhibit HMGCR activity, and the resulting reductions of blood levels of LDL cholesterol have been shown to substantially reduce risk for coronary heart disease.

The wide range of inter-individual efficacy of HMGCR inhibitor drugs (statins) is a major issue in the treatment of patients in need of cholesterol-lowering therapy. Thus there is a need for a test to evaluate an individual's sensitivity to HMGCR inhibitors, such as statins.

Advantage
This invention provides for such a test to evaluate an individual's sensitivity to HMGCR inhibitors, such as statins. It also provides methods for identifying agents that modulate HMGCR activity, while avoiding elevation of the statin-resistant isoform of HMGCR.

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