Driving patient compliance with therapy

• US 9,828,624 B2
• Filed: 07/24/2013
• Issued: 11/28/2017
• Est. Priority Date: 07/24/2013
• Status: Active Grant

• Current Assignee: Boston Heart Diagnostics Corporation (Eurofins Scientific SE)
• Original Assignee: Boston Heart Diagnostics Corporation (Eurofins Scientific SE)
• Inventors: Schaefer, Ernst J.
• Primary Examiner(s): McDonald, Jennifer
• Assistant Examiner(s): Xu, Qing
• Application Number:
  US13/949,847
• Publication Number:
  US 20150031058A1
• Time in Patent Office: 1,588 Days
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 31/397 having four-membered rings, e.g. azetidine
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: C12Q 1/60 involving cholesterol
• CPC Class Codes: G01N 33/5008 for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743

Abstract

Methods of the invention involve determining a patient'"'"'s compliance with a cholesterol lowering therapy. In certain aspects, the invention provides methods that involve conducting a first assay to determine a cholesterol biomarker level in a first sample from a patient prior to the patient undergoing a cholesterol lowering therapy. The methods may also involve conducting a second assay to determine a cholesterol level in a second sample obtained from the patient after the patient has started undergoing a cholesterol lowering therapy. Additionally, the methods involve associating the cholesterol level and the cholesterol biomarker level in which the association allows for the determination of the patient'"'"'s compliance with the cholesterol lowering therapy.

Claims

1. A method for determining a patient'"'"'s compliance with a cholesterol lowering therapy and treating the patient, the method comprising:

conducting a first assay to determine a level of a cholesterol absorption sterol and a level of a cholesterol production sterol in a first sample obtained from a patient prior to undergoing a cholesterol lowering therapy;

comparing the level of the cholesterol absorption sterol against the level of the cholesterol production sterol to classify the patient as a balanced producer, an over producer, or an over-absorber of cholesterol;

conducting a second assay to determine a cholesterol level in a second sample obtained from the patient after the patient has started undergoing the cholesterol lowering therapy;

identifying the patient as non-compliant with the cholesterol lowering therapy when the patient'"'"'s cholesterol level has not decreased as expected compared to a prior cholesterol level taken from the patent before undergoing the cholesterol lowering therapy and given the patient'"'"'s classification; and

administering an alternative therapy to the patient in response to identifying the patient as non-compliant with the cholesterol lowering therapy.

2. The method of claim 1, wherein the first and second samples are blood samples.

3. The method of claim 1, wherein the cholesterol absorption sterol is selected from the group consisting of campesterol, beta-sitosterol, and a combination thereof.

4. The method of claim 1, wherein the cholesterol production sterol is selected from the group consisting of lathosterol, desmosterol, and a combination thereof.

5. The method of claim 1, wherein a drug administered in the cholesterol lowering therapy comprises a drug that inhibits cholesterol production.

6. The method of claim 5, wherein the drug that inhibits cholesterol production is a statin.

7. The method of claim 1, wherein a drug administered in the cholesterol lowering therapy comprises a drug that inhibits cholesterol absorption.

8. The method of claim 7, wherein the drug that inhibits cholesterol absorption is an ezetimibe.

9. The method of claim 1, wherein the cholesterol level is a level of LDL cholesterol.