IP Library Patent Application 12953687
Patent Application
App. No. 12/953,687

Uses of Lp-PLA2 in combination to assess coronary risk

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Patent No.
US None
App. No.
12/953,687
Abstract

This invention relates to a method for assessing risk of Coronary Vascular Disease (CVD). Specifically, it relates to utilizing risk assessment from both Lipoprotein Associated Phospholipase A2 (Lp-PLA2) and C-reactive protein (CRP) in combination. In addition the invention relates to a method for assessing risk of Coronary Vascular Disease (CVD) in a patient with low to normal Low Density Lipoprotein Cholesterol (LDL) levels utilizing both LDL and Lipoprotein Associated Phospholipase A2 (Lp-PLA2). Moreover, the invention relates to the use of risk associated with Lp-PLA2, CRP and LDL in combination and specific ranges thereof to predict Coronary Vascular Disease.

Claims (31)

1 . A method for assessing risk of Coronary Vascular Disease (CVD) in a patient which comprises measuring levels of both Lipoprotein Associated Phospholipase A2 (Lp-PLA2) and C-reactive protein (CRP) or Low Density Lipoprotein Cholesterol (LDL) in the patient, analyzing a risk of CVD associated with the level of CRP or LDL and a risk of CVD associated with the level of Lp-PLA2, and using a combined risk to assess the risk of CVD in the patient.

2 . The method of claim 1 wherein the Coronary Vascular Disease (CVD) is Coronary Heart Disease (CHD).

3 . The method of claim 1 wherein levels of all three markers, LDL, CRP and Lp-PLA2, are analyzed so as to use a combined risk of all three markers to assess the risk of CVD in the patient.

4 . The method of claim 1 wherein the measuring of CRP or LDL and Lp-PLA2 levels are done simultaneously.

5 . The method of claim 1 wherein the measuring of CRP or LDL and Lp-PLA2 are done sequentially.

6 . The method of claim 1 wherein levels of CRP and Lp-PLA2 are analyzed and the respective levels of CRP and Lp-PLA2 are based on dividing a patient population dataset into high and low levels of each CRP and Lp-PLA2 and a patient having both high CRP and high Lp-PLA2 levels is indicative of heightened risk of CVD.

7 . The method of claim 1 wherein levels of CRP and LP-PLA2 are analyzed and the respective levels of CRP and Lp-PLA2 are based on dividing a patient population dataset into high, medium and low levels of each CRP and Lp-PLA2 and a patient having both high CRP and high Lp-PLA2 levels is indicative of heightened risk of CVD.

8 . The method of claim 3 wherein

(a) the respective levels of CRP, LDL and Lp-PLA2 are based on dividing a patient population dataset into high and low levels of each CRP, LDL and Lp-PLA2; and

(b) a patient having low LDL levels but having both high CRP and high Lp-PLA2 levels is indicative of heightened risk of CVD for the patient.

9 . The method of claim 3 wherein

(a) the respective levels of CRP and Lp-PLA2 are based on dividing a patient population dataset into high, medium and low levels of each CRP and Lp-PLA2;

(b) the respective level of LDL is based on dividing the patient population dataset into high and low levels of LDL; and

(c) a patient having low LDL levels but having both high CRP and high Lp-PLA2 levels is indicative of heightened risk of CVD for the patient.

10 . The method of claim 1 further comprising determining the patients risk of CVD using the Adult Treatment Panel III (ATP III) guidelines.

11 . The method claim 1 wherein the Lp-PLA2 levels are determined by measuring either Lp-PLA2 mass or Lp-PLA2 activity.

12 . The method of claim 1 wherein levels of LDL and Lp-PLA2 are analyzed and the respective levels of LDL and Lp-PLA2 are based on dividing a patient population dataset into high and low levels of each LDL and Lp-PLA2 and a patient having high Lp-PLA2 levels and low to normal LDL is indicative of heightened risk of CVD.

13 . The method of claim 1 wherein levels of LDL and LP-PLA2 are analyzed and wherein the levels of Lp-PLA2 are based on dividing a patient population dataset into high, medium and low levels of Lp-PLA2 and a patient having both high Lp-PLA2 levels and low to normal LDL is indicative of heightened risk of CVD.

14 . The method of claim 1 wherein the patient suffers from a metabolic disorder.

15 . The method of claim 14 where in the metabolic disorder is selected from the group consisting of, obesity, overweight, diabetes, insulin resistance, anorexia, and cachexia.

16 . The method of claim 15 wherein the patient is both diabetic and hypertensive.

17 . The method of claim 15 wherein the patient is diabetic, hypertensive and smokes.

18 . The method of claim 1 wherein Coronary Vascular Disease (CVD) is selected from the group comprising Coronary Heart Disease (CHD), stroke, myocardial infarction, coronary revascularization and congestive heart failure.

19 . The method of claim 1 wherein Coronary Vascular Disease (CVD) is stroke.

20 . The method of claim 1 wherein Coronary Vascular Disease (CVD) is myocardial infarction.

21 . The method of claim 1 wherein measuring levels of both Lp-PLA2 and CRP or LDL in the patient comprises measuring levels of both Lp-PLA2 and CRP or LDL in a sample from said patient.

22 . A method for treating a subject to reduce the risk of a Coronary Vascular Disease (CVD), comprising: selecting and administering to a subject who has above-normal levels of both C-reactive protein (CRP) and Lipoprotein Associated Phospholipase A2 (Lp-PLA2) or both above-normal levels of Lp-PLA2 and low to normal levels of Low Density Lipoprotein Cholesterol (LDL), a therapeutic molecule selected from the group consisting of statins, Lp-PLA2 inhibitors or cholesterol reuptake inhibitors in an amount effective to lower the risk of the subject developing a future CVD.

23 . The method of claim 22 wherein the Coronary Vascular Disease (CVD) is Coronary Heart Disease (CHD).

24 . A kit for diagnosing a patient's susceptibility to Coronary Vascular Disease (CVD) comprising both a suitable assay for measuring Lipoprotein Associated Phospholipase A2 (Lp-PLA2) levels and a suitable assay for measuring C-reactive protein (CRP) levels or Low Density Lipoprotein Cholesterol (LDL) levels wherein the levels of both CRP and Lp-PLA2 or both LDL and Lp-PLA2 are determined.

25 . The kit of claim 24 wherein the Coronary Vascular Disease (CVD) is Coronary Heart Disease (CHD).

26 . The kit of claim 24 wherein the suitable assay for measuring Lp-PLA2 levels measures either Lp-PLA2 mass or Lp-PLA2 activity assay.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 7, 2017
From: GENERAL ATOMICS
To: DIAZYME LABORATORIES, INC.
Reel/Frame 041651/0661 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 4, 2017
From: DIADEXUS, INC.
To: GENERAL ATOMICS
Reel/Frame 041245/0899 →
CHANGE OF NAME Recorded Dec 28, 2016
From: DIADEXUS, INC.
To: DIADEXUS, INC.
Reel/Frame 040791/0732 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 24, 2010
From: WOLFERT, ROBERT L.; MAGUIRE, YU PING; LI, YU PING; SARNO, MARK JOSEPH
To: DIADEXUS, INC.
Reel/Frame 025419/0365 →