METHODS FOR DETERMINING HOW TO TREAT CONGESTIVE HEART FAILURE

• US 20080077025A1
• Filed: 07/11/2006
• Published: 03/27/2008
• Est. Priority Date: 07/11/2005
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Padley, Robert J., Salon, Jeffrey E., Thakkar, Roopal B., Huang, Bidan, Delgado-Herrera, Leticia
• Application Number:
  US11/456,741
• Publication Number:
  US 20080077025A1
• Time in Patent Office: Days
• US Class Current: 600/508
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61K 31/50 Pyridazines; Hydrogenated pyridazines
• CPC Class Codes: G06Q 30/0217 involving input on products or services in exchange for incentives or rewards
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention relates to methods for determining how to treat congestive heart failure.

Claims

1. A method of predicting an improved clinical outcome in a patient diagnosed with congestive heart failure, the method comprising the steps of:

(a) obtaining a systolic blood pressure, diastolic blood pressure or mean arterial pressure from a patient;

(b) determining whether the systolic blood pressure, diastolic blood pressure or mean arterial pressure of said patient fits at least one predetermined criterion showing a likelihood of an improved clinical outcome; and

(e) predicting said improved clinical outcome based upon the determination in step (b).

2. The method of claim 1 wherein the predetermined criterion showing a likelihood of improved clinical outcome is a systolic blood pressure less than, equal to or greater, than about 100 mmHg.

3. The method of claim 1 wherein the predetermined criterion showing a likelihood of improved clinical outcome is a diastolic blood pressure less than, equal to or greater than about 60 mmHg.

4. The method of claim 1 wherein the predetermined criterion showing a likelihood of improved clinical outcome is a mean arterial pressure less than, equal to or greater than about 75 mmHg.

5. The method of claim 1 wherein the patient is suffering from acutely decompensated congestive heart failure.

6. The method of claim 1 wherein a systolic blood pressure equal to or greater than about 100 mmHg indicates an increased likelihood of an improved clinical outcome.

7. The method of claim 1 wherein a systolic blood pressure less than about 100 mmHg indicates a decreased likelihood of an improved clinical outcome.

59. A pharmaceutical drug product comprising:

(a) a pharmaceutical drug for the treatment of congestive heart failure in a pharmaceutically-acceptable form for administration to a human, and

(b) printed media or labeling accompanying said pharmaceutical drug in said pharmaceutically acceptable form, wherein said printed media or labeling discloses the method as in any one of claims 1, 8, 19, 30, 39 or 48.

60. A pharmaceutical drug product comprising:

(a) levosimendan in a pharmaceutically-acceptable form for administration to a human, and

(b) printed media or labeling accompanying said levosimendan, wherein said printed media or labeling discloses the method as in any one of claims 1, 8, 19, 30 39 or 48.

61. A business method comprising, providing a drug for the treatment of congestive heart failure in a pharmaceutically-acceptable form for administration to a human, and

encouraging a decision maker to refer to printed or electronic media disclosing a method as in any one of claims 1, 8, 19, 30, 39 or 48.

62. A business method comprising, providing levosimendan in a pharmaceutically-acceptable form for administration to a human, and encouraging a decision maker to refer to printed or electronic media disclosing a method as in any one of claims 1, 8, 19, 30, 39 or 48.

63. A method of promoting the sale or use of a drug for the treatment of congestive heart failure, the method comprising:

(a) providing said drug in a pharmaceutically-acceptable form for administration to a human, and

(b) providing a customer with printed, graphic, or electronic media disclosing a method as in any one of claims 1, 8, 19, 30, 39 or 48.

64. A method of promoting the sale or use of levosimendan, the method comprising:

(a) providing said levosimendan in a pharmaceutically-acceptable form for administration to a human, and

(b) providing a customer with printed, graphic, or electronic media disclosing a method as in any one of claims 1, 8, 19, 30, 39 or 48.

8. A method for determining whether or not to begin a course of monotherapy with an inotropic drug or a vasodilator in a patient diagnosed with congestive heart failure, the method comprising the steps of:

(a) obtaining a systolic blood pressure, diastolic blood pressure or mean arterial pressure from a patient;

(b) analyzing the systolic blood pressure, diastolic blood pressure or mean arterial pressure of said patient to determine whether said blood pressure, diastolic blood pressure or mean diastolic blood pressure fits at least one predetermined criterion; and

(c) determining whether to begin a course of monotherapy in the patient based upon the analysis in step (b).

9. The method of claim 8 wherein the predetermined criterion is a systolic blood pressure less than, equal to or greater than about 100 mmHg.

10. The method of claim 8 wherein the predetermined criterion is a diastolic blood pressure less than, equal to or greater than about 60 mmHg.

11. The method of claim 8 wherein the predetermined criterion is a mean arterial pressure less than, equal to or greater than about 75 mmHg.

12. The method of claim 8 wherein in step (c), a determination is made not to begin a course of monotherapy with an inotropic drug or a vasodilator because the patient was determined to have a systolic blood pressure less than about 100 mmHg in step (b).

13. The method of claim 8 wherein in step (c), a determination is made to begin a course of monotherapy with an inotropic drug or a vasodilator because the patient was determined to have a systolic blood pressure about equal to or greater than about 100 mmHg in step (b).

14. The method of claims 8 or 13 further comprising the step of administering an effective amount of an inotropic drug or a vasodilator to the patient based upon the determination in step (c).

15. The method of claim 14 wherein the inotropic drug or vasodilator is administered to the patient orally, buccally, intravenously, intramuscularly, subcutaneously or by inhalation.

16. The method of claim 14 wherein the inotropic drug is levosimendan, dopamine, dobutamine, inamrinone, milrinone, dopexamine or digoxin.

17. The method of claim 14 wherein the vasodilator is hydralazine, hydralazine hydrochloride, nicorandil, fenoldopam, natriuretic peptides, natrecor, nesiritide, nitroprusside, nitroprusside sodium, nipride, milrinone, primacor, nitroglycerin, glyceryl trinitrate, isosorbide dinitrate or isosorbide mononitrate.

18. The method of claim 8 wherein the patient is suffering from acutely decompensated congestive heart failure.

19. A method for determining whether or not to begin a course of combination therapy with at least one inotropic drug, at least one vasodilator or combinations thereof in a patient diagnosed with congestive heart failure, the method comprising the steps of:

(a) obtaining a systolic blood pressure, diastolic blood pressure or mean arterial pressure from a patient;

(b) analyzing the systolic blood pressure, diastolic blood pressure or mean arterial pressure of said patient to determine whether said blood pressure, diastolic blood pressure or mean diastolic blood pressure fits at least one predetermined criterion; and

(c) determining whether to begin a course of combination therapy with at least one inotropic drug, at least one vasodilator or combinations thereof in the patient based upon the analysis in step (b).

20. The method of claim 19 wherein the predetermined criterion is a systolic blood pressure less than, equal to or greater than about 100 mmHg.

21. The method of claim 19 wherein the predetermined criterion is a diastolic blood pressure less than, equal to or greater than about 60 mmHg.

22. The method of claim 19 wherein the predetermined criterion is a mean arterial pressure less than, equal to or greater than about 75 mmHg.

23. The method of claim 19 wherein in step (c), a determination is made not to begin a course of combination therapy with at least one inotropic drug, at least one vasodilator or combinations thereof because the patient was determined to have a systolic blood pressure less than about 100 mmHg in step (b).

24. The method of claim 19 wherein in step (c), a determination is made to begin a course of combination therapy with at least one inotropic drug, at least one a vasodilator or combinations thereof because the patient was determined to have a systolic blood pressure equal to or greater than about 100 mmHg in step (b).

25. The method of claims 19 or 24 further comprising the step of administering an effective amount at least one inotropic drug, at least one vasodilator or combinations thereof to the patient based upon the determination in step (c).

26. The method of claim 25 wherein the at least one inotropic drug, at least one vasodilator or combinations thereof is administered to the patient orally, buccally, intravenously, intramuscularly, subcutaneously or by inhalation.

27. The method of claim 25 wherein the inotropic drug is levosimendan, dopamine, dobutamine, inamrinone, milrinone, dopexamine or digoxin.

28. The method of claim 25 wherein the vasodilator is hydralazine, hydralazine hydrochloride, nicorandil, fenoldopam, natriuretic peptides, natrecor, nesiritide, nitroprusside, nitroprusside sodium, nipride, milrinone, primacor, nitroglycerin, glyceryl trinitrate, isosorbide dinitrate or isosorbide mononitrate.

29. The method of claim 19 wherein the patient is suffering from acutely decompensated congestive heart failure.

30. A method for determining whether to continue or discontinue a course of monotherapy in a patient diagnosed with congestive heart failure wherein said patient is currently being treated with an inotropic drug or a vasodilator, the method comprising the steps of:

(a) obtaining a systolic blood pressure, diastolic blood pressure or mean arterial pressure from a patient;

(b) analyzing the systolic blood pressure, diastolic blood pressure or mean arterial pressure of said patient to determine whether said systolic blood pressure, diastolic blood pressure or mean diastolic blood pressure fits at least one predetermined criterion; and

(c) determining whether to continue or discontinue the course of monotherapy with the inotropic drug or vasodilator in said patient based upon the analysis in step (b).

31. The method of claim 30 wherein the predetermined criterion is a systolic blood pressure less than, equal to or greater than about 100 mmHg.

32. The method of claim 30 wherein the predetermined criterion is a diastolic blood pressure less than, equal to or greater than about 60 mmHg.

33. The method of claim 30 wherein the predetermined criterion is a mean arterial pressure less than, equal to or greater than about 75 mmHg.

34. The method of claim 30 wherein in step (c), a determination is made not to continue a course of monotherapy because the patient was determined to have a systolic blood pressure less than about 100 mmHg in step (b).

35. The method of claim 30 wherein in step (c), a determination is made to continue a course of monotherapy because the patient was determined to have a systolic blood pressure equal to or greater than about 100 mmHg in step (b).

36. The method of claim 30 wherein the inotropic drug is levosimendan, dopamine, dobutamine, inamrinone, milrinone, dopexamine or digoxin.

37. The method of claim 30 wherein the vasodilator is hydralazine, hydralazine hydrochloride, nicorandil, fenoldopam, natriuretic peptides, natrecor, nesiritide, nitroprusside, nitroprusside sodium, nipride, milrinone, primacor, nitroglycerin, glyceryl trinitrate, isosorbide dinitrate or isosorbide mononitrate.

38. The method of claim 30 wherein the patient is suffering from acutely decompensated congestive heart failure.

39. A method for determining whether to continue or discontinue a course of combination therapy in a patient diagnosed with congestive heart failure wherein said patient is currently being treated with a combination of at least one inotropic drug, at least one vasodilator or combinations thereof the method comprising the steps of:

(a) obtaining a systolic blood pressure, diastolic blood pressure or a mean arterial pressure from a patient;

(b) analyzing the systolic blood pressure, diastolic blood pressure or mean arterial pressure of said patient to determine whether said systolic blood pressure, diastolic blood pressure or mean diastolic blood pressure fits at least one predetermined criterion; and

(c) determining whether to continue or discontinue the course of combination therapy with the at least one inotropic drug, at least one vasodilator or combinations thereof in said patient based upon the analysis in step (b).

40. The method of claim 39 wherein the predetermined criterion is a systolic blood pressure less than, equal to or greater than about 100 mmHg.

41. The method of claim 39 wherein the predetermined criterion is a diastolic blood pressure less than, equal to or greater than about 60 mmHg.

42. The method of claim 39 wherein the predetermined criterion is a mean arterial pressure less than, equal to or greater than about 75 mmHg.

43. The method of claim 39 wherein in step (c), a determination is made not to continue a course of combination therapy because the patient was determined to have a systolic blood pressure less than about 100 nm mg in step (b).

44. The method of claim 39 wherein in step (c), a determination is made to continue a course of combination therapy because the patient was determined to have a systolic blood pressure equal to or greater than about 100 mmHg in step (b).

45. The method of claim 40 wherein the inotropic drug is levosimendan, dopamine, dobutamine, inamrinone, milrinone, dopexamine or digoxin.

46. The method of claim 40 wherein the vasodilator is hydralazine, hydralazine hydrochloride, nicorandil, fenoldopam, natriuretic peptides, natrecor, nesiritide, nitroprusside, nitroprusside sodium, nipride, milrinone, primacor, nitroglycerin, glyceryl trinitrate, isosorbide dinitrate or isosorbide mononitrate.

47. The method of claim 40 wherein the patient is suffering from acutely decompensated congestive heart failure.

48. A method of optimizing an existing drug treatment regimen in a patient diagnosed with congestive heart failure and receiving at least one inotropic drug, at least one vasodilator, at least one beta-blocker or combinations thereof, the method comprising the steps of:

(a) obtaining a systolic blood pressure, diastolic blood pressure or mean arterial pressure from a patient;

(b) analyzing the systolic blood pressure, diastolic blood pressure or mean arterial pressure of said patient to determine whether said systolic blood pressure, diastolic blood pressure or mean diastolic blood pressure fits at least one predetermined criterion; and

(c) optimizing the treatment regimen in the patient based upon the analysis in step (b).

49. The method of claim 48 wherein the predetermined criterion is a systolic blood pressure less than, equal to or greater than about 100 mmHg.

50. The method of claim 48 wherein the predetermined criterion is a diastolic blood pressure less than, equal to or greater than about 60 mmHg.

51. The method of claim 48 wherein the predetermined criterion is a mean arterial pressure less than, equal to or greater than about 75 mmHg.

52. The method of claim 48 wherein in step (c), a determination is made to optimize the treatment regimen by discontinuing the treatment of the patient with at least one inotropic drug, at least one vasodilator, at least one beta-blocker or combinations thereof based upon the determination in step (b) that the patient has a systolic blood pressure less than about 100 mmHg.

53. The method of claim 48 wherein in step (c), the treatment regimen is optimized by substituting an effective amount of at least one different inotropic drug, at least one different vasodilator, at least one different beta-blocker or different combinations thereof that are not currently being used in the existing treatment regimen for at least one inotropic drug, at least one vasodilator, at least one beta-blocker or combinations thereof that is currently being used in the existing treatment regimen based upon the determination in step (b) that the patient has a systolic blood pressure about equal to or greater than about 100 mmHg.

54. The method of claim 48 wherein in step (c), the treatment regimen is optimized by adding an effective amount of at least one inotropic drug, at least one vasodilator, at least one beta-blocker or combinations thereof that are not currently being used in the existing treatment regimen based upon the determination in step (b) that the patient has a systolic blood pressure about equal to or greater than about 100 mmHg.

55. The method of claims 52, 53 or 54 wherein the inotropic drug is levosimendan, dopamine, dobutamine, inamrinone, milrinone, dopexamine or digoxin.

56. The method of claims 52, 53 or 54 wherein the vasodilator is hydralazine, hydralazine hydrochloride, nicorandil, fenoldopam, natriuretic peptides, natrecor;

nesiritide, nitroprusside, nitroprusside sodium, nipride, milrinone, primacor, nitroglycerin, glyceryl trinitrate, isosorbide dinitrate or isosorbide mononitrate.

57. The methods of claims 52, 53 or 54 wherein the beta-blocker is labetalol, carvedilol, atenolol, esmolol, esmolol hydrochloride, metoprolol, metoprolol succinate, metoprolol tartrate, bisoprolol fumarate, bisoprolol, propranolol or propranolol hydrochloride.

58. The method of claim 48 wherein the patient is suffering from acutely decompensated congestive heart failure.