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Claims for Patent: 7,368,469

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Claims for Patent: 7,368,469

Title:Use of inhibitors of the renin-angiotensin system in the prevention of cardiovascular events
Abstract:Use of an inhibitor of the renin-angiotensin system or a pharmaceutically acceptable derivative thereof, optionally together with another antihypertensive, a cholesterol lowering agent, a diuretic or aspirin, in the manufacture of a medicament for the prevention of cardiovascular events; a method of preventing cardiovascular events comprising administering to a patient in need of such prevention an effective amount of an inhibitor of the renin angiotensin system or a pharmaceutically acceptable derivative thereof, optionally together with another antihypertensive, a cholesterol lowering agent, a diuretic or aspirin; and a combination product containing an an inhibitor of the renin-angiotensin system or a pharmaceutically acceptable derivative thereof and a cholesterol lowering agent.
Inventor(s): Scholkens; Bernward (Kelkheim, DE), Bender; Norbert (Hofheim, DE), Rangoonwala; Badrudin (Hofheim, DE), Dagenais; Gilles (St.-Nicholas, CA), Gerstein; Hertzel (Hamilton, CA), Yusuf; Salim (Carlisle, CA)
Assignee: Sanofi-Aventis Deutschland GmbH (Frankfurt, DE)
Application Number:11/490,061
Patent Claims: 1. A method for reducing the risk of a cardiovascular event in a patient with an increased cardiovascular risk and no evidence of left ventricular dysfunction, which comprises administering to the patient an effective amount of at least one ACE inhibitor chosen from ramipril, ramiprilat, pharmaceutically acceptable salts of ramipril, and pharmaceutically acceptable salts of ramiprilat, wherein the cardiovascular event is stroke, cardiovascular death or myocardial infarction.

2. A method according to claim 1, where the patient has an increased cardiovascular risk due to a manifest coronary heart disease, a history of transient ischaemic attacks or stroke or a history of peripheral vascular disease.

3. A method according to claim 1, where the patient is diabetic.

4. A method according to claim 3, where the patient has at least one other risk factor.

5. A method according to claim 4, where the other risk factor is chosen from current or previous hypertension, elevated total cholesterol, low HDL cholesterol, current cigarette smoking, known microalbuminuria and previous vascular disease.

6. A method according to claim 1, where the patient is non-hypertensive.

7. A method according to claim 1, where the patient is older than 55 years.

8. A method according to claim 1, which further comprises administering a cholesterol lowering agent to the patient.

9. A method according to claim 8, where the cholesterol lowering agent is a statin.

10. A method according to claim 9, where the statin is lovastatin, pravastatin, simvastatin, fluvastatin or mixtures thereof.

11. A method according to claim 10, where the statin is pravastatin.

12. A method according to claim 10, where the statin is simvastatin.

13. A method according to claim 1, which further comprises administering a calcium channel blocker or a beta blocker to the patient.

14. A method according to claim 1, which further comprises administering, an antihypertensive, a diuretic or aspirin to the patient.

15. A method according to claim 1, wherein the ACE inhibitor is ramipril.

16. A method according to claim 1, wherein the ACE inhibitor is ramiprilat.

17. A method according to claim 1, wherein the cardiovascular event is stroke.

18. A method according to claim 1, wherein the cardiovascular event is cardiovascular death.

19. A method according to claim 1, wherein the cardiovascular event is myocardial infarction.

20. A method for reducing the risk of a cardiovascular event in a patient with an increased cardiovascular risk and no evidence of left ventricular dysfunction, which comprises administering to the patient an effective amount of at least one ACE inhibitor chosen from ramipril, ramiprilat, pharmaceutically acceptable salts of ramipril, and pharmaceutically acceptable salts of ramiprilat, wherein the cardiovascular event is congestive heart failure, worsening of angina, cardiac arrest or a revascularization procedure.

21. A method according to claim 20, where the revascularization procedure is coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, peripheral angioplasty surgery, amputation or carotid endarterectomy.

22. A method according to claim 20, where the patient has an increased cardiovascular risk due to a manifest coronary heart disease, a history of transient ischaemic attacks or stroke or a history of peripheral vascular disease.

23. A method according to claim 20, where the patient is diabetic.

24. A method according to claim 23, where the patient has at least one other risk factor.

25. A method according to claim 24, where the other risk factor is chosen from current or previous hypertension, elevated total cholesterol, low HDL cholesterol, current cigarette smoking, known microalbuminuria and previous vascular disease.

26. A method according to claim 20, where the patient is non-hypertensive.

27. A method according to claim 20, where the patient is older than 55 years.

28. A method according to claim 20, which further comprises administering a cholesterol lowering agent to the patient.

29. A method according to claim 28, where the cholesterol lowering agent is a statin.

30. A method according to claim 29, where the statin is lovastatin, pravastatin, simvastatin, fluvastatin or mixtures thereof.

31. A method according to claim 30, where the statin is pravastatin.

32. A method according to claim 30, where the statin is simvastatin.

33. A method according to claim 20, which further comprises administering a calcium channel blocker or a beta blocker to the patient.

34. A method according to claim 20, which further comprises administering an antihypertensive, a diuretic or aspirin to the patient.

35. A method according to claim 20, wherein the ACE inhibitor is ramipril.

36. A method according to claim 20, wherein the ACE inhibitor is ramiprilat.

37. A method according to claim 1, wherein the ACE inhibitor is administered in an amount from about 0.01 mg/kg/day to about 1 mg/kg/day.

38. A method according to claim 15, wherein the ramipril is administered in an amount of 2.5 mg/day.

39. A method according to claim 15, wherein the ramipril is administered in an amount of 5 mg/day.

40. A method according to claim 15, wherein the ramipril is administered in an amount of 10 mg/day.

41. A method according to claim 1, wherein the ACE inhibitor is administered in a tablet.

42. A method according to claim 1, wherein the ACE inhibitor is administered in a capsule.

43. A method according to claim 20, wherein the ACE inhibitor is administered in an amount from about 0.01 mg/kg/day to about 1 mg/kg/day.

44. A method according to claim 35, wherein the ramipril is administered in an amount of 2.5 mg/day.

45. A method according to claim 35, wherein the ramipril is administered in an amount of 5 mg/day.

46. A method according to claim 35, wherein the ramipril is administered in an amount of 10 mg/day.

47. A method according to claim 20, wherein the ACE inhibitor is administered in a tablet.

48. A method according to claim 20, wherein the ACE inhibitor is administered in a capsule.

49. A method for reducing the risk of a cardiovascular event in a patient who exhibits no left ventricular dysfunction, which comprises administering to the patient an effective amount of at least one ACE inhibitor chosen from ramipril, ramiprilat, pharmaceutically acceptable salts of ramipril, and pharmaceutically acceptable salts of ramiprilat, wherein the patient has an increased cardiovascular risk due to at least two risk factors chosen from a history of coronary heart disease, a history of transient ischaemic attacks, a history of stroke, and a history of peripheral vascular disease; and wherein the cardiovascular event is stroke, cardiovascular death or myocardial infarction.

50. A method according to claim 49, where the patient is diabetic.

51. A method according to claim 50, where the patient has at least one other risk factor.

52. A method according to claim 51, where the other risk factor is chosen from current or previous hypertension, elevated total cholesterol, low HDL cholesterol, current cigarette smoking, known microalbuminuria and previous vascular disease.

53. A method according to claim 49, where the patient is non-hypertensive.

54. A method according to claim 49, where the patient is older than 55 years.

55. A method according to claim 49, which further comprises administering a cholesterol lowering agent to the patient.

56. A method according to claim 55, where the cholesterol lowering agent is a statin.

57. A method according to claim 56, where the statin is lovastatin, pravastatin, simvastatin, fluvastatin or mixtures thereof.

58. A method according to claim 57, where the statin is pravastatin.

59. A method according to claim 57, where the statin is simvastatin.

60. A method according to claim 49, which further comprises administering a calcium channel blocker or a beta blocker to the patient.

61. A method according to claim 49, which further comprises administering an antihypertensive, a diuretic or aspirin to the patient.

62. A method according to claim 49, wherein the ACE inhibitor is ramipril.

63. A method according to claim 62, wherein the ramipril is administered in an amount of 2.5 mg/day.

64. A method according to claim 62, wherein the ramipril is administered in an amount of 5 mg/day.

65. A method according to claim 62, wherein the ramipril is administered in an amount of 10 mg/day.

66. A method according to claim 49, wherein the ACE inhibitor is ramiprilat.

67. A method according to claim 49, wherein the cardiovascular event is stroke.

68. A method according to claim 49, wherein the cardiovascular event is cardiovascular death.

69. A method according to claim 49, wherein the cardiovascular event is myocardial infarction.

70. A method according to claim 49, wherein the ACE inhibitor is administered in an amount from about 0.01 mg/kg/day to about 1 mg/kg/day.

71. A method according to claim 49, wherein the ACE inhibitor is administered in a tablet.

72. A method according to claim 49, wherein the ACE inhibitor is administered in a capsule.

73. A method for reducing the risk of a cardiovascular event in a patient who exhibits no left ventricular dysfunction, which comprises administering to the patient an effective amount of at least one ACE inhibitor chosen from ramipril, ramiprilat, pharmaceutically acceptable salts of ramipril, and pharmaceutically acceptable salts of ramiprilat, wherein the patient has an increased cardiovascular risk due to at least two risk factors chosen from a history of coronary disease, a history of transient ischaemic attacks, a history of stroke, and a history of peripheral vascular disease; and wherein the cardiovascular event is congestive heart failure, worsening of angina, cardiac arrest or a revascularization procedure.

74. A method according to claim 73, where the revascularization procedure is coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, peripheral angioplasty surgery, amputation or carotid endarterectomy.

75. A method according to claim 74, where the patient is diabetic.

76. A method according to claim 75, where the patient has at least one other risk factor.

77. A method according to claim 76, where the other risk factor is chosen from current or previous hypertension, elevated total cholesterol, low HDL cholesterol, current cigarette smoking, known microalbuminuria and previous vascular disease.

78. A method according to claim 73, where the patient is non-hypertensive.

79. A method according to claim 73, where the patient is older than 55 years.

80. A method according to claim 73, which further comprises administering a cholesterol lowering agent to the patient.

81. A method according to claim 80, where the cholesterol lowering agent is a statin.

82. A method according to claim 81, where the statin is lovastatin, pravastatin, simvastatin, fluvastatin or mixtures thereof.

83. A method according to claim 82, where the statin is pravastatin.

84. A method according to claim 82, where the statin is simvastatin.

85. A method according to claim 73, which further comprises administering a calcium channel blocker or a beta blocker to the patient.

86. A method according to claim 73, which further comprises administering an antihypertensive, a diuretic or aspirin to the patient.

87. A method according to claim 73, wherein the ACE inhibitor is ramipril.

88. A method according to claim 87, wherein the ramipril is administered in an amount of 2.5 mg/day.

89. A method according to claim 87, wherein the ramipril is administered in an amount of 5 mg/day.

90. A method according to claim 87, wherein the ramipril is administered in an amount of 10 mg/day.

91. A method according to claim 73, wherein the ACE inhibitor is ramiprilat.

92. A method according to claim 73, wherein the ACE inhibitor is administered in an amount from about 0.01 mg/kg/day to about 1 mg/kg/day.

93. A method according to claim 73, wherein the ACE inhibitor is administered in a tablet.

94. A method according to claim 73, wherein the ACE inhibitor is administered in a capsule.
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