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Details for Patent: 6,040,147

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Details for Patent: 6,040,147

Title: Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Abstract:The invention involves methods for characterizing an individual's risk profile of developing a future cardiovascular disorder by obtaining a level of the marker of systemic inflammation in the individual. The invention also involves methods for evaluating the likelihood that an individual will benefit from treatment with an agent for reducing the risk of future cardiovascular disorder.
Inventor(s): Ridker; Paul (Chestnut Hill, MA), Hennekens; Charles H. (South Natick, MA)
Assignee: The Brigham and Women's Hospital, Inc. (Boston, MA)
Filing Date:Apr 02, 1998
Application Number:09/054,212
Claims:1. A method for characterizing an apparently healthy, nonsmoking individual's risk profile of developing a future myocardial infarction, comprising obtaining a level of a marker of systemic inflammation in the individual,

comparing the level of the marker to a predetermined value, and

characterizing the individual's risk profile of developing a future myocardial infarction based upon the level of the marker in comparison to the predetermined value.

2. The method of claim 1, wherein the predetermined value is a plurality of predetermined marker level ranges and said comparing step comprises determining in which of said predetermined marker level ranges said individuals level falls.

3. The method of claim 1, wherein the marker of systemic inflammation is selected from the group consisting of C-reactive protein, a cytokine and a cellular adhesion molecule.

4. The method of claim 1, wherein the marker of systemic inflammation is C-reactive protein.

5. The method of claim 4, wherein the predetermined value is about 13/4 mg/l of blood or higher.

6. The method of claim 4, wherein the predetermined value is about 2.0 mg/l of blood.

7. The method of claim 4, wherein the predetermined marker level is a plurality of predetermined marker level ranges, one of said plurality being below about 1.75 mg/l blood and another of said ranges being about 1.75 mg/l blood, and wherein said comparing step comprises determining in which of said plurality of predetermined marker level ranges said individual's level falls.

8. The method of claim 1, wherein the marker of systemic inflammation is soluble intercellular adhesion molecule (sICAM-1).

9. The method of claim 8, wherein the predetermined value is about 250 ng/ml of blood or higher.

10. A method for characterizing an individual's risk profile of developing a future cardiovascular disorder associated with atherosclerotic disease, other than fatal myocardial infarction, comprising

obtaining a level of a marker of systemic inflammation in the individual,

comparing the level of the marker to a predetermined value, and

characterizing the individual's risk profile of developing said future cardiovascular disorder associated with atherosclerotic diseases other than fatal myocardial infarction, based upon the level of the marker in comparison to the predetermined level.

11. The method of claim 10, wherein the predetermined value is a plurality of predetermined marker level ranges and said comparing step comprises determining in which of said predetermined marker level ranges said individuals level falls.

12. The method of claim 10, wherein said individual is an apparently healthy, non-smoking individual.

13. The method of claim 10, wherein the marker of systemic inflammation is selected from the group consisting of C-reactive protein, a cytokine and a cellular adhesion molecule.

14. The method of claim 10, wherein the marker of systemic inflammation is C-reactive protein.

15. The method of claim 14, wherein the predetermined value is about 13/4 mg/l of blood.

16. The method of claim 14, wherein the predetermined value is about 2.0 mg/l of blood.

17. The method of claim 14, wherein the predetermined marker level is a plurality of predetermined marker level ranges, one of said plurality being below about 1.75 mg/l blood and another of said ranges being about 1.75 mg/l blood, and wherein said comparing step comprises determining in which of said plurality of predetermined marker level ranges said individual's level falls.

18. The method of claim 10, wherein the marker of systemic inflammation is soluble intercellular adhesion molecule (sICAM-1).

19. The method of claim 18, wherein the predetermined value is about 250 ng/ml of blood or higher.

20. The method of any one of claim 10-19, wherein the cardiovascular disorder is stroke.

21. The method of any one of claims 10-19, wherein the cardiovascular disorder is nonfatal myocardial infarction.

22. A method for characterizing an individual's risk profile of developing a future cardiovascular disorder associated with atherosclerotic disease, comprising

obtaining a level of a marker of systemic inflammation in the individual,

comparing the level of the marker to a first predetermined value to establish a first risk value,

obtaining a level of a cholesterol in the individual,

comparing the level of the cholesterol to a second predetermined value to establish a second risk value, and

characterizing the individual's risk profile of developing the cardiovascular disorder based upon the combination of the first risk value and the second risk value, wherein the combination of the first risk value and second risk value establishes a third risk value different from said first and second risk values.

23. The method of claim 22, wherein the first predetermined value is a first plurality of predetermined marker level ranges and said comparing step comprises determining in which of said predetermined marker level ranges said individuals level falls.

24. The method of claim 22, wherein said individual is an apparently healthy, non-smoking individual.

25. The method of claim 22, wherein the marker of systemic inflammation is selected from the group consisting of C-reactive protein, a cytokine and a cellular adhesion molecule.

26. The method of claim 22, wherein the marker of systemic inflammation is C-reactive protein.

27. The method of claim 26, wherein the first predetermined value is about 13/4 mg/l of blood.

28. The method of claim 26, wherein the first predetermined value is about 2.0 mg/l of blood.

29. The method of claim 26, wherein the first predetermined marker level is a plurality of predetermined marker level ranges, one of said plurality being below about 1.75 mg/l blood and another of said ranges being about 1.75 mg/l blood, and wherein said comparing step comprises determining in which of said plurality of predetermined marker level ranges said individual's level falls.

30. The method of claim 22, wherein the marker of systemic inflammation is soluble intercellular adhesion molecule (sICAM-1).

31. The method of claim 30, wherein the first predetermined value is about 250 ng/ml of blood or higher.

32. The method of any one of claims 22-31, wherein the cardiovascular disorder is stroke.

33. The method of any one of claims 22-31, wherein the cardiovascular disorder is nonfatal myocardial infarction.

34. The method of any one of claims 22-31, wherein the third risk value is greater than either of the first and second risk values.

35. A method for evaluating the likelihood that an individual will benefit from treatment with an agent for reducing the risk of an cardiovascular disorder associated with atherosclerotic disease, the agent selected from the group consisting of anti-inflammatory agents, anti-thrombotic agents, anti-platelet agents, fibrinolytic agents, lipid reducing agents, direct thrombin inhibitors, and glycoprotein II b/IIIa receptor inhibitors comprising:

obtaining a level of a marker of systemic inflammation in the individual, and

comparing the level of the marker to a predetermined value, wherein the level of the marker of systemic inflammation in comparison to the predetermined value is indicative of whether the individual will benefit from treatment with said agents.

36. The method of claim 35, wherein the predetermined value is a plurality of predetermined marker level ranges and said comparing step comprises determining in which of said predetermined marker level ranges said individuals level falls.

37. The method of claim 35, wherein said individual is an apparently healthy, non-smoking individual.

38. The method of claim 35, wherein the marker of systemic inflammation is selected from the group consisting of C-reactive protein, a cytokine and a cellular adhesion molecule.

39. The method of claim 35, wherein the marker of systemic inflammation is C-reactive protein.

40. The method of claim 39, wherein the predetermined value is about 13/4 mg/l of blood or higher.

41. The method of claim 39, wherein the predetermined value is about 2.0 mg/l of blood or higher.

42. The method of claim 39, wherein the predetermined marker level is a plurality of predetermined marker level ranges, one of said plurality being below about 1.75 mg/l blood and another of said ranges being about 1.75 mg/l blood, and wherein said comparing step comprises determining in which of said plurality of predetermined marker level ranges said individual's level falls.

43. The method of claim 35, wherein the marker of systemic inflammation is soluble intercellular adhesion molecule (sICAM-1).

44. The method of claim 43, wherein the predetermined value is about 250 ng/ml blood or higher.

45. The method of any one of claims 35-44, wherein the cardiovascular disorder is stroke.

46. The method of any one of claims 35-44, wherein the cardiovascular disorder is myocardial infarction.

47. The method of any one of claims 35-44, wherein the agent is aspirin.
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