Method for the Diagnosis and Treatment of Conditions Involving Aberrant Erythrocyte Potassium Levels

• US 20090274776A1
• Filed: 04/30/2007
• Published: 11/05/2009
• Est. Priority Date: 04/28/2006
• Status: Abandoned Application

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Almeida, Antonio Delgado, Delgado, Maria Carolina
• Application Number:
  US12/297,840
• Publication Number:
  US 20090274776A1
• Time in Patent Office: Days
• US Class Current: 424/722
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: G01N 2800/321 Arterial hypertension
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/80 involving blood groups or blood types or red blood cells white blood cells G01N33/56972
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

The present invention provides a systematic approach that allows health care providers (e.g., physicians) to use erythrocyte potassium measurements as an indicator of hypertension or risk of developing hypertension. In particular, the present invention provides systems and methods for treating conditions involving aberrant erythrocyte potassium levels (e.g., hypertension), preventing the onset of conditions involving aberrant erythrocyte potassium levels, identifying individuals at risk for developing hypertension, and evaluating the effectiveness of treatments for conditions involving aberrant erythrocyte potassium levels (e.g., hypertension).

Claims

1. A method of evaluating the effectiveness of a hypertension treatment for an individual, comprising:

a) administering said hypertension treatment to said individual,

b) obtaining erythrocyte potassium levels for said individual, and

c) evaluating the effectiveness of said hypertension treatment based upon said obtained erythrocyte potassium levels.

2. The method of claim 1, further comprising the step of obtaining a baseline erythrocyte potassium level for said individual prior to said administering of said hypertension treatment.

3. The method of claim 1, wherein said obtaining erythrocyte potassium levels occurs during the course of said hypertension treatment.

4. The method of claim 1, further comprising the step of obtaining a post-treatment erythrocyte potassium level.

5. The method of claim 1, further comprising the step of adjusting or monitoring said treatment so as to maintain said erythrocyte potassium level at or above a desired erythrocyte potassium level.

6. The method of claim 5, wherein said individual is a human being over 20 years of age.

7. The method of claim 6, wherein said desired erythrocyte potassium level is approximately 90 mmol/L per cell.

8. The method of claim 6, wherein said approximately 90 mmol/L per cell is 90 mmol/L per cell.

9. The method of claim 5, wherein said individual is a human being under 21 years of age.

10. The method of claim 9, wherein said desired erythrocyte potassium level is approximately 94 mmol/L per cell.

11. The method of claim 10, wherein said approximately 94 mmol/L per cell is 94 mmol/L per cell.

12. The method of claim 6, wherein an increase in said individual'"'"'s erythrocyte potassium levels above approximately 90 mmol/L per cell during said hypertension treatment administration indicates said hypertension treatment is effective.

13. The method of claim 6, wherein a decrease in said individual'"'"'s erythrocyte potassium levels below approximately 90 mmol/L per cell during said hypertension treatment administration indicates said hypertension treatment is ineffective.

14. The method of claim 9, wherein an increase in said individual'"'"'s erythrocyte potassium levels above approximately 94 mmol/L per cell during said hypertension treatment administration indicates said hypertension treatment is effective.

15. The method of claim 9, wherein a decrease in said individual'"'"'s erythrocyte potassium levels below approximately 94 mmol/L per cell during said hypertension treatment administration indicates said hypertension treatment is ineffective.

16. The method of claim 1, wherein said obtaining erythrocyte potassium levels comprises a collection of a blood sample from said individual and analysis of said blood sample.

17. The method of claim 16, wherein said analysis of said blood sample comprises measurement of said erythrocyte potassium levels.

18. The method of claim 16, wherein said measurement is accomplished with a hand-held device.

19. The method of claim 1, wherein said hypertension treatment comprises life-style modification.

20. The method of claim 1, wherein said hypertension treatment comprises a pharmacological treatment.

21. The method of claim 1, wherein said hypertension treatment comprises an experimental treatment.

22. The method of claim 19, wherein said life-style modification comprises one or more life-style modifications selected from the group consisting of a dietary change, a reduction in alcohol intake, an increase in aerobic activity, a reduction or elimination of nicotine intake, an adequate intake of dietary calcium and magnesium, and a reduction of sodium intake.

23. The method of claim 20, wherein said pharmacological treatment comprises one or more pharmacological treatments selected from the group consisting of administration of one or more potassium sparing drugs, administration of one or more aldosterone blocking drugs, administration of one or more potassium oral supplements, and administration of one or more anti-hypertensive drugs.

24. A method of diagnosing risk for hypertension, comprising:

a) obtaining an adult individual'"'"'s erythrocyte potassium level, and

b) diagnosing said individual as being;

i) at low risk for hypertension if said erythrocyte potassium level is above approximately 90 mmol/L per cell, or

ii) at high risk for hypertension if said erythrocyte potassium level is at or below approximately 90 mmol/L per cell.

25. The method of claim 24, wherein said approximately 90 mmol/L per cell is 90 mmol/L per cell.

26. The method of diagnosing of claim 24, further comprising the step of administering a hypertension treatment to said individual if said adult individual is diagnosed as being at high risk for hypertension.

27. The method of claim 26, wherein said hypertension treatment comprises a life-style modification.

28. The method of claim 26, wherein said hypertension treatment comprises a pharmacological treatment.

29. The method of claim 27, wherein said life-style modification comprises one or more life-style modifications selected from the group consisting of a dietary change, a reduction in alcohol intake, an increase in aerobic activity, a reduction or elimination of nicotine intake, an adequate intake of dietary calcium and magnesium, and a reduction of sodium intake.

30. The method of claim 28, wherein said pharmacological treatment comprises one or more pharmacological treatments selected from the group consisting of administration of one or more potassium sparing drugs, administration of one or more aldosterone blocking drugs, administration of one or more potassium oral supplements, and administration of one or more anti-hypertensive drugs.

31. The method of claim 24, wherein said adult individual is a human being over 20 years old.

32. A method of diagnosing risk for hypertension, comprising:

a) obtaining an child individual'"'"'s erythrocyte potassium level, and

b) diagnosing said individual as being;

i) at low risk for hypertension if said erythrocyte potassium level is above approximately 94 mmol/L per cell, or

ii) at high risk for hypertension if said erythrocyte potassium level is at or below approximately 94 mmol/L per cell.

33. The method of claim 32, wherein said approximately 94 mmol/L per cell is 94 mmol/L per cell.

34. The method of diagnosing of claim 32, further comprising the step of administering a hypertension treatment to said individual if said adult individual is diagnosed as being at high risk for hypertension.

35. The method of claim 34, wherein said hypertension treatment comprises a life-style modification.

36. The method of claim 34, wherein said hypertension treatment comprises a pharmacological treatment.

37. The method of claim 35, wherein said life-style modification comprises one or more life-style modifications selected from the group consisting of a dietary change, a reduction in alcohol intake, an increase in aerobic activity, a reduction or elimination of nicotine intake, an adequate intake of dietary calcium and magnesium, and a reduction of sodium intake.

38. The method of claim 36, wherein said pharmacological treatment comprises one or more pharmacological treatments selected from the group consisting of administration of one or more potassium sparing drugs, administration of one or more aldosterone blocking drugs, administration of one or more potassium oral supplements, and administration of one or more anti-hypertensive drugs.

39. The method of claim 32, wherein said adult individual is a human being under 21 years old.

40. A method of treating hypertension, comprising

administering to an individual diagnosed as having hypertension a treatment configured to increase said individual'"'"'s erythrocyte potassium level above a predetermined erythrocyte potassium level threshold,

obtaining at least one measurement of said individual'"'"'s erythrocyte potassium levels during the course of said treatment, and

monitoring the effectiveness of said treatment through comparison of said measured erythrocyte potassium levels with said predetermined erythrocyte potassium level threshold.

41. The method of claim 40, wherein said individual is a human being over 20 years of age.

42. The method of claim 41, wherein said predetermined erythrocyte potassium level threshold is approximately 90 mmol/L per cell.

43. The method of claim 42, wherein said approximately 90 mmol/L per cell is 90 mmol/L per cell.

44. The method of claim 40, wherein said individual is a human being under 21 years of age.

45. The method of claim 44, wherein said predetermined erythrocyte potassium level threshold is approximately 94 mmol/L per cell.

46. The method of claim 45, wherein said approximately 94 mmol/L per cell is 94 mmol/L per cell.

47. The method of claim 40, wherein said treatment comprises a life-style modification.

48. The method of claim 40, wherein said treatment comprises a pharmacological treatment.

49. The method of claim 47, wherein said life-style modification comprises one or more life-style modifications selected from the group consisting of a dietary change, a reduction in alcohol intake, an increase in aerobic activity, a reduction or elimination of nicotine intake, an adequate intake of dietary calcium and magnesium, and a reduction of sodium intake.

50. The method of claim 48, wherein said pharmacological treatment comprises one or more pharmacological treatments selected from the group consisting of administration of one or more potassium sparing drugs, administration of one or more aldosterone blocking drugs, administration of one or more potassium oral supplements, and administration of one or more anti-hypertensive drugs.

51. A method of preventing the onset of hypertension, comprising

administering to an individual at risk for developing hypertension a treatment configured to increase said individual'"'"'s erythrocyte potassium level above a predetermined erythrocyte potassium level threshold,

obtaining at least one measurement of said individual'"'"'s erythrocyte potassium levels during the course of said treatment, and

monitoring the effectiveness of said treatment through comparison of said measured erythrocyte potassium levels with said predetermined erythrocyte potassium level threshold.

52. The method of claim 51, wherein said individual is a human being over 20 years of age.

53. The method of claim 52, wherein said predetermined erythrocyte potassium level threshold is approximately 90 mmol/L per cell.

54. The method of claim 53, wherein said approximately 90 mmol/L per cell is 90 mmol/L per cell.

55. The method of claim 51, wherein said individual is a human being under 21 years of age.

56. The method of claim 55, wherein said predetermined erythrocyte potassium level threshold is approximately 94 μ

mmol/L per cell.

57. The method of claim 56, wherein said approximately 94 mmol/L per cell is 94 mmol/L per cell.

58. The method of claim 51, wherein said treatment comprises a life-style modification.

59. The method of claim 51, wherein said treatment comprises a pharmacological treatment.

60. The method of claim 58, wherein said life-style modification comprises one or more life-style modifications selected from the group consisting of a dietary change, a reduction in alcohol intake, an increase in aerobic activity, a reduction or elimination of nicotine intake, an adequate intake of dietary calcium and magnesium, and a reduction of sodium intake.

61. The method of claim 59, wherein said pharmacological treatment comprises one or more pharmacological treatments selected from the group consisting of administration of one or more potassium sparing drugs, administration of one or more aldosterone blocking drugs, administration of one or more potassium oral supplements, and administration of one or more anti-hypertensive drugs.

62. A device for monitoring an individual'"'"'s risk for hypertension, wherein said device is configured to:

a) receive a sample comprising erythrocytes from an individual;

b) measure the erythrocyte potassium level within said erythrocytes;

c) compare said measured erythrocyte potassium level with a predetermined erythrocyte potassium level threshold; and

d) report information pertaining to said comparison.

63. The device of claim 62, wherein said measured erythrocyte potassium levels above said predetermined erythrocyte potassium level threshold represent a low risk for hypertension, and wherein said measured erythrocyte potassium levels below said predetermined erythrocyte potassium level threshold represent a high risk for hypertension.

64. The device of claim 62, wherein said information is risk for hypertension.

65. The device of claim 62, wherein said information is an indication of whether said measured erythrocyte potassium level is above or below said predetermined erythrocyte potassium level threshold.

66. The device of claim 62, wherein said device is a hand-held device.

67. The device of claim 62, wherein said individual is a human being over 20 years of age.

68. The device of claim 67, wherein said predetermined erythrocyte potassium level threshold is approximately 90 mmol/L per cell.

69. The device of claim 68, wherein said approximately 90 mmol/L per cell is 90 mmol/L per cell.

70. The device of claim 62, wherein said individual is a human being under 21 years of age.

71. The device of claim 70, wherein said predetermined erythrocyte potassium level threshold is approximately 94 mmol/L per cell.

72. The device of claim 71, wherein said approximately 94 mmol/L per cell is 94 mmol/L per cell.

73. The device of claim 62, wherein said device is configured to utilize flame emission spectroscopy for purposes of measuring said individual'"'"'s erythrocyte potassium level.

74. The device of claim 62, wherein said device is configured to utilize potassium selective electrodes for purposes of measuring said individual'"'"'s erythrocyte potassium level.

75. The device of claim 62, the device has therein a processor that conducts said comparing.

76. The device of claim 75, wherein said processor is configured to interact with software configured to accomplish said comparing of said measured erythrocyte potassium level with said predetermined erythrocyte potassium level threshold.

77. The device of claim 62, wherein said reporting is wireless communication to the Internet.

78. The device of claim 62, wherein said reporting is wireless communication to a server.

79. The device of claim 62, wherein said reporting is a textually based message displayed on said device.

80. The device of claim 62, wherein said reporting is an audible message presented with said device.