Relevance of achieved levels of markers of systemic inflammation following treatment
First Claim
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1. A method for diagnosing a human subject, comprising:
- (i) obtaining a level of a marker of systemic inflammation in a human subject undergoing therapy with a statin to reduce the risk of a future cardiovascular event, wherein the marker is selected from the group consisting of;
C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM-1), ICAM 3, BL-CAM, LFA-2, VCAM-1, NCAM, PECAM, fibrinogen, serum amyloid A (SAA), lipoprotein associated phospholipase A2 (LpPlA2), sCD40 ligand, myeloperoxidase, Interleukin-6 (IL-6), and Interleukin-8 (IL-8), (ii) obtaining a level of low density lipoprotein cholesterol (LDLC) in the human subject, (iii) comparing the level of the marker obtained in (i) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, and (iv) determining whether the level of the marker obtained in (i) is above a predetermined level, said determination being indicative of whether the patient would benefit from continued therapy with the statin or would benefit from a change in therapy with the statin, when the level of LDLC obtained in (ii) is below 70 mg/dL or is above 100 mg/dL.
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Abstract
The invention involves, inter alia, the use of markers of systemic inflammation to determine whether or not an individual undergoing treatment with a cardiovascular agent to reduce the risk of a future cardiovascular event will benefit from continued treatment with the cardiovascular agent. Further, this invention describes the use of markers of systemic inflammation to evaluate the efficacy of treatment and to assist physicians in deciding on the course of a treatment in an individual at risk of future cardiovascular events.
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Citations
57 Claims
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1. A method for diagnosing a human subject, comprising:
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(i) obtaining a level of a marker of systemic inflammation in a human subject undergoing therapy with a statin to reduce the risk of a future cardiovascular event, wherein the marker is selected from the group consisting of;
C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM-1), ICAM 3, BL-CAM, LFA-2, VCAM-1, NCAM, PECAM, fibrinogen, serum amyloid A (SAA), lipoprotein associated phospholipase A2 (LpPlA2), sCD40 ligand, myeloperoxidase, Interleukin-6 (IL-6), and Interleukin-8 (IL-8),(ii) obtaining a level of low density lipoprotein cholesterol (LDLC) in the human subject, (iii) comparing the level of the marker obtained in (i) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, and (iv) determining whether the level of the marker obtained in (i) is above a predetermined level, said determination being indicative of whether the patient would benefit from continued therapy with the statin or would benefit from a change in therapy with the statin, when the level of LDLC obtained in (ii) is below 70 mg/dL or is above 100 mg/dL. - View Dependent Claims (2, 7)
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3-6. -6. (canceled)
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8-10. -10. (canceled)
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11. A method for evaluating the efficacy of a therapy for reducing the risk of a future cardiovascular event comprising:
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(i) obtaining a level of a marker of systemic inflammation in a human subject undergoing therapy with a statin to reduce the risk of a future cardiovascular event, wherein the marker is selected from the group consisting of;
C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM-1), ICAM 3, BL-CAM, LFA-2, VCAM-1, NCAM, PECAM, fibrinogen, serum amyloid A (SAA), lipoprotein associated phospholipase A2 (LpPlA2), sCD40 ligand, myeloperoxidase, Interleukin-6 (IL-6), and Interleukin-8 (IL-8),(ii) obtaining a level of LDLC in said human subject, (iii) comparing the level of the marker obtained in (i) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, and (iv) determining whether the level of the marker obtained in (i) is above a predetermined level said determination being indicative of whether the therapy is efficacious, when the level of LDLC obtained in (ii) is below 70 mg/dL or above 100 mg/dL. - View Dependent Claims (17)
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12. The method of claim II wherein step (i) and step (ii) are repeated so as to monitor the human subject'"'"'s levels of the marker of systemic inflammation and LDLC over time.
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13-16. -16. (canceled)
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18-20. -20. (canceled)
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21. A method for diagnosing a patient, comprising:
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(i) obtaining a level of a marker of systemic inflammation in a human subject undergoing therapy with a therapeutic agent other than a statin to reduce the risk of a future cardiovascular event, wherein the marker is selected from the group consisting of;
C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM-1), ICAM 3, BL-CAM, LFA-2, VCAM-1, NCAM, PECAM, fibrinogen, serum amyloid A (SAA), lipoprotein associated phospholipase A2 (LpPlA2), sCD40 ligand, myeloperoxidase, Interleukin-6 (IL-6), and Interleukin-8 (IL-8),(ii) comparing the level of the marker obtained in (i) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, and (iii) determining whether the level of the marker obtained in (i) is above the predetermined level, said determination being indicative of whether the patient would benefit from continued therapy with the agent or would benefit from a change in therapy with the agent. - View Dependent Claims (22, 27)
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23-26. -26. (canceled)
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28-31. -31. (canceled)
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32. A method for evaluating the efficacy of a therapy with a therapeutic agent other than a statin for reducing the risk of a future cardiovascular event comprising:
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(i) obtaining a level of a marker of systemic inflammation in a human subject undergoing the therapy to reduce the risk of a future adverse cardiovascular event, wherein the marker is selected from the group consisting of;
C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM-1), ICAM 3, BL-CAM, LFA-2, VCAM-1, NCAM, PECAM, fibrinogen, serum amyloid A (SAA), lipoprotein associated phospholipase A2 (LpPlA2), sCD40 ligand, myeloperoxidase, Interleukin-6 (IL-6), and Interleukin-8 (IL-8),(ii) comparing the level of the marker obtained in (i) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, and (iii) determining whether the level of the marker obtained in (i) is above the predetermined level, said determination being indicative of whether the therapy is efficacious. - View Dependent Claims (33, 38, 42)
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34-37. -37. (canceled)
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39-41. -41. (canceled)
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43. A method for deciding on the course of a therapy in a human subject, comprising:
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(i) obtaining a level of a marker of systemic inflammation in a human subject undergoing a therapy to reduce the risk of a future adverse cardiovascular event, wherein the marker of systemic inflammation is selected from the group consisting of;
C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM-1), ICAM 3, BL-CAM, LFA-2, VCAM-1, NCAM, PECAM, fibrinogen, serum amyloid A (SAA), lipoprotein associated phospholipase A2 (LpPlA2), sCD40 ligand, myeloperoxidase, Interleukin-6 (IL-6), and Interleukin-8 (IL-8),(ii) comparing the level of the marker obtained in (i) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, (iii) determining whether the level of the marker obtained in (i) is above the predetermined level, and (iv) deciding on the course of the therapy based on such determination. - View Dependent Claims (44, 49, 53)
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45-48. -48. (canceled)
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50-52. -52. (canceled)
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54. A method for treating a human subject with an elevated level of a marker of systemic inflammation comprising:
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(i) treating the human subject with a first therapy for reducing the risk of a cardiovascular event, (ii) obtaining a level of the marker of systemic inflammation in the human subject, (iii) comparing the level of the marker obtained in (ii) to a predetermined value corresponding to a level of the marker in an apparently healthy control population, and, if the predetermined level of the marker is not reached, (iv) treating the human subject with a second therapy for reducing the risk of a cardiovascular event, and repeating (ii) and (iii) until the predetermined level of the marker is reached. - View Dependent Claims (55, 56)
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57-59. -59. (canceled)
Specification