Methods for determining LDL cholesterol treatment

• US 9,817,001 B2
• Filed: 07/18/2013
• Issued: 11/14/2017
• Est. Priority Date: 05/27/2008
• Status: Active Grant

• Current Assignee: Boston Heart Diagnostics Corporation (Eurofins Scientific SE)
• Original Assignee: Boston Heart Diagnostics Corporation (Eurofins Scientific SE)
• Inventors: Asztalos, Bela F., Schaefer, Ernst J.
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US13/945,436
• Publication Number:
  US 20140088072A1
• Time in Patent Office: 1,580 Days
• Field of Search: 435 11
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743

Abstract

Disclosed is a personalized diagnostic and treatment solution for cardiovascular disease. The invention comprises methods for devising a personalized treatment plan for a patient via the use of an extended CVD risk assessment panel measuring markers of cholesterol absorption and production and HDL subfractions. This solution provides a more complete risk assessment of an individual than merely measuring traditional CVD risk markers alone, and enables the healthcare practitioner to optimize therapy for patients with or without established CVD. This solution presents the advantages of greater accuracy, savings in time and cost over existing testing and treatment methods.

Claims

1. A method for determining a cardiovascular disease (CVD) diagnosis and a personalized treatment for a patient, the method comprising

obtaining one or more samples from a patient;

measuring the one or more samples for levels of a plurality of HDL subfractions selected from the group consisting of α

-1, α

-2, α

-3, α

-4, and preβ

-1 to create an HDL fingerprint, and when the HDL fingerprint indicates that the patient should be treated, then measuring the one or more samples for levels of;

at least one marker of cholesterol absorption and at least one marker of cholesterol production, wherein the marker of cholesterol absorption is selected from the group consisting of beta-sitosterol and campesterol, and the marker of cholesterol production is lathosterol;

comparing the levels of the marker of cholesterol absorption and the marker of cholesterol production to corresponding reference levels;

classifying based on the comparison if the patient is a hypo-absorber, a hyper-absorber, an over-producer, a normal-producer of cholesterol or a combination thereof, wherein a level of lathosterol greater than the reference level indicates that the patient is an over-producer and a level of beta-sitosterol or campesterol higher than a corresponding reference level indicates that the patient is a hyper-absorber;

determining a CVD diagnosis and a personalized therapy in response to the patient'"'"'s classification when the patient'"'"'s HDL fingerprint indicates that the patient should be treated.

2. The method of claim 1, wherein the personalized therapy comprises administering an ezetimibe.

3. The method of claim 1, wherein the sample is a blood sample.

4. The method of claim 1, wherein a level of lathosterol greater than a reference level indicates that the patient should be administered a statin therapy.

5. The method of claim 1, wherein a high level of beta-sitosterol indicates that the patient is a hyper-absorber, wherein the high level of beta-sitosterol is greater than 160 mmol×

10²/mol of cholesterol.

6. The method of claim 1, wherein a high level of campesterol indicates that the patient is a hyper-absorber, wherein the high level of campesterol is greater than 300 mmol×

10²/mol of cholesterol.