Method for evaluating and treating hypertension

• US 6,632,180 B1
• Filed: 09/07/2000
• Issued: 10/14/2003
• Est. Priority Date: 09/07/2000
• Status: Expired due to Fees

• Current Assignee: John H. Laragh
• Original Assignee: John H. Laragh
• Inventors: Laragh, John H.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/657,027
• Time in Patent Office: 1,132 Days
• Field of Search: 600/481, 600/483, 600/484, 600/485, 600/486, 600/490, 600/479, 600/480, 600/454, 600/300, 600/301, 424/9.1, 424/9.2
• US Class Current: 600/481
• CPC Class Codes: G01N 2800/321 Arterial hypertension
• CPC Class Codes: G01N 2800/324 Coronary artery diseases, e.g. angina pectoris, myocardial infarction
• 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 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The Laragh Method is a novel method useful for evaluating and treating hypertensive patients. The Laragh Method provides a systematic approach for the physician to use volume vasoconstriction information with entry and induced changes in blood pressure and in ambulatory plasma renin levels for the rational selection of treatment tailored to suit each individual hypertensive patient. The Laragh Method provides a systematic and rational approach to drug selection which greatly improves the therapeutic success rate among hypertensive patients and which for the large majority provides long-term blood pressure control with one drug instead of two or two instead of three with each drug rationally targeted to control the renin and/or volume elements in the blood pressure equation.

Claims

1. A method for treating patients with hypertension comprising:

A. measuring the plasma renin activity (PRA) of each patient;

B. if a patient'"'"'s PRA≧

0.65, then;

i. prescribing an R drug at a low dose;

ii. increasing the dose of the R drug if a patient'"'"'s blood pressure (BP) is not adequately controlled after B(i);

iii. prescribing a V drug at a low dose in addition to the R drug if a patient'"'"'s BP is not adequately controlled after B(ii);

iv. increasing the dose of the V drug if a patient'"'"'s BP is not adequately controlled after B(iii), and measuring the PRA;

v. if the BP is not adequately controlled after B(iv), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5; and

c. switching the V drug to a second R drug if PRA≧

6.5;

C. if a patient'"'"'s PRA<

0.65, then;

i. prescribing a V drug at a low dose;

ii. increasing the dose of the V drug if a patient'"'"'s blood pressure (BP) is not adequately controlled after C(i);

iii. prescribing an R drug at a low dose in addition to the V drug if a patient'"'"'s BP is not adequately controlled after C(ii);

iv. increasing the dose of the R drug if a patient'"'"'s BP is not adequately controlled after C(iii), and measuring the PRA;

v. if the BP is not adequately controlled after B(iv), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5; and

c. switching the V drug to a second R drug if PRA≧

6.5.

10. A computer program relating to the treatment of hypertension comprising a computer readable format that accepts patient information and processes it to make treatment recommendations according to the methods of any of claims 1-9.

11. An internet website relating to the treatment of hypertension comprising an interactive format that collects and processes patient information to make treatment recommendations according to the methods of any of claim 1-9.

12. A method of treating patients with hypertension according to any of claims 1-6, wherein the patient'"'"'s plasma renin activity is measured by the Sealey and Laragh PRA test.

2. A method for treating patients with hypertension who have a plasma renin activity (PRA) ≧

0.65, comprising;

A. prescribing an R drug at a low dose;

B. increasing the dose of the R drug if a patient'"'"'s blood pressure (BP) is not adequately controlled after A;

C. prescribing a V drug at a low dose in addition to the R drug if a patient'"'"'s BP is not adequately controlled after B;

D. increasing the dose of the V drug if a patient'"'"'s BP is not adequately controlled after C, and measuring the PRA;

E. if the BP is not adequately controlled after D, then;

i. switching the R drug to a second V drug if PRA<

0.65;

ii. prescribing a second R drug if 0.65≦

PRA<

6.5; and

iii. switching the V drug to a second R drug if PRA≧

6.5.

3. A method for treating patients with hypertension who have a plasma renin activity (PRA) of <

0.65, comprising;

A. prescribing a V drug at a low dose;

B. increasing the dose of the V drug if a patient'"'"'s blood pressure (BP) is not adequately controlled after A;

C. prescribing an R drug at a low dose in addition to the V drug if a patient'"'"'s BP is not adequately controlled after B;

D. increasing the dose of the R drug if a patient'"'"'s BP is not adequately controlled after C, and measuring the PRA;

E. if the BP is not adequately controlled after D, then;

i. switching the R drug to a second V drug if PRA<

0.65;

ii. prescribing a second R drug if 0.65≦

PRA<

6.5; and

iii. switching the V drug to a second R drug if PRA≧

6.5.

4. A method of treating and diagnosing curable forms of hypertension comprising:

A. measuring the plasma renin activity (PRA) of each patient;

B. if the PRA<

0.65 for a patient, then prescribing a test for hypokalemia;

i. if a patient is hypokalemic, then prescribing a 24 hr. urine aldosterone test;

a. if the urine aldersterone is high, then prescribing an adrenal CT scan and an adrenal vein sample, and if the adrenal CT scan and the adrenal vein sample are positive for aldosteronism, prescribing a unilateral adrenalectomy, otherwise go to B(ii);

b. if the urine aldosterone is not high, then go to B(ii);

ii. if a patient is not hypokalemic or B(i) refers the patient to this step, then prescribing a V drug at a low dose, measuring the blood pressure (BP) and if the BP is not adequately controlled, increasing the dose of the V drug;

iii. if the BP is not adequately controlled after B(ii), then prescribing an R drug at a low dose in addition to the V drug;

iv. if the BP is not adequately controlled after B(iii), then increasing the dose of the R drug and measuring the PRA;

v. if the BP is not adequately controlled after B(iv), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a.second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5;

C. if the PRA≧

1.6, then prescribing a captopril test;

i. if the captopril test is negative, go to D(i), otherwise prescribing renal vein sampling;

ii. if the renal vein sampling is negative, go to D(i), otherwise prescribing a renal angiogram;

iii. if the renal angiogram is negative, go to D(i), otherwise prescribing renal angioplasty or surgical revascularization;

D. if the 1.6>

PRA≧

0.65, then;

i. prescribing an R drug at a low dose, measuring the BP and if the BP is not adequately controlled, increasing the dose of the R drug;

ii. if the BP is not adequately controlled after D(i), then prescribing a V drug at a low dose in addition to the R drug;

iii. if the BP is not adequately controlled after D(ii), then increasing the dose of the V drug and measuring the PRA;

iv. if the BP is not adequately controlled after D(iii), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5.

5. A method of treating hypertensive patients who have not adequately responded to previous treatment using a V drug, R drug or a V and R drug together, comprising:

A. measuring the plasma renin activity (PRA) of each patient;

B. if the PRA<

0.65 and the patient was taking a V drug, then;

i. increasing the dose of the V drug if the dose was low, otherwise go to B(ii);

ii. if the BP is not adequately controlled after B(i), then prescribing an R drug at a low dose in addition to the V drug;

iii. if the BP is not adequately controlled after B(ii), then increasing the dose of the R drug and measuring the PRA;

iv. if the BP is not adequately controlled after B(iii), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5;

C. if the PRA<

0.65 and the patient was taking an R drug, then;

i. prescribing a V drug at a low dose instead of prescribing the R drug, measuring the BP and if the BP is not adequately controlled, increasing the dose of the V drug;

ii. if the BP is not adequately controlled after C(i), then prescribing an R drug at a low dose in addition to the V drug;

iii. if the BP is not adequately controlled after C(ii), then increasing the dose of the R drug and measuring the PRA;

iv. if the BP is not adequately controlled after C(iii), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5;

D. if PRA<

0.65 and the patient was taking a V drug and R drug, then

i. switching the R drug to a second V drug if PRA<

0.65;

ii. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

iii. switching the V drug to a second R drug if PRA≧

6.5;

E. if the 0.65≦

PRA<

6.5, and the patient was taking a V drug, then;

i. increasing the dose of the V drug if the dose was low, otherwise go to E(ii);

ii. if the BP is not adequately controlled after E(i), then prescribing an R drug at a low dose in addition to the V drug;

iii. if the BP is not adequately controlled after E(ii), then increasing the dose of the R drug and measuring the PRA;

iv. if the BP is not adequately controlled after E(iii), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V-drug to a second R drug if PRA≧

6.5;

F. if 0.65≦

PRA<

6.5, and the patient was taking an R drug, then;

i. increasing the dose of the R drug if the dose was low, otherwise go to F(ii);

ii. if the BP is not adequately controlled after F(i), then prescribing a V drug at a low dose in addition to the R drug;

iii. if the BP is not adequately controlled after F(ii), then increasing the dose of the V drug and measuring the PRA;

iv. if the BP is not adequately controlled after F(iii), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5;

G. if 0.65≦

PRA<

6.5, and the patient was taking a V drug and an R drug, then;

i. switching the R drug to a second V drug if PRA<

0.65;

ii. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

iii. switching the V drug to a second R drug if PRA≧

6.5;

H. if PRA≧

6.5, and the patient was taking a V drug, then;

i. prescribing an R drug at a low dose instead of prescribing the R drug, measuring the BP and if the BP is not adequately controlled, increasing the dose of the R drug;

ii. if the BP is not adequately controlled after H(i), then prescribing a V drug at a low dose in addition to the R drug;

iii. if the BP is not adequately controlled after H(ii), then increasing the dose of the V drug and measuring the PRA;

iv. if the BP is not adequately controlled after H(iii), then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5;

I. if PRA≧

6.5, and the patient was taking an R drug, then;

i. increasing the dose of the R drug if the dose was low, otherwise go to I(ii);

ii. if the BP is not adequately controlled after I(i), then prescribing a V drug at a low dose in addition to the R drug;

iii. if the BP is not adequately controlled after l(ii), then increasing the dose of the V drug and measuring the PRA;

iv. if the BP is not adequately controlled, then;

a. switching the R drug to a second V drug if PRA<

0.65;

b. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

c. switching the V drug to a second R drug if PRA≧

6.5;

J. if PRA≧

6.5, and the patient was taking a V drug and an R drug, then;

i. switching the R drug to a second V drug if PRA<

0.65;

ii. prescribing a second R drug if 0.65≦

PRA<

6.5;

or

iii. switching the V drug to a second R drug if PRA≧

6.5.

6. A method for treating patients with.hypertension when they visit a physician, clinic or hospital comprising:

on the first visit, drawing blood from each patient for a plasma renin activity (PRA) test;

on the second visit, prescribing a low dose R drug if a patient'"'"'s PRA≧

0.65 and a low dose V drug if a patient'"'"'s PRA<

0.65;

on the third visit, measuring the patient'"'"'s blood pressure (BP) and if the BP is not adequately controlled, increasing the dose of the R drug or V drug;

on the fourth visit, measuring the patient'"'"'s BP and if the BP is not adequately controlled, in addition to the R drug or V drug the patient is already taking, prescribe a low dose V drug to a patient who was receiving an R drug and a low dose R drug to a patient who was receiving a V drug;

on the fifth visit, measuring the patient'"'"'s BP and drawing blood for a plasma renin activity (PRA) test if the BP is not adequately controlled, then measure the PRA and increase the dose of the V drug of a patient that was taking a high dose R drug and a low dose V drug and increase the dose of the R drug of a patient that was taking a high dose V drug and a low dose R drug;

on the sixth visit, measuring the patient'"'"'s BP and if the BP is not adequately controlled, then;

switching the R drug to a second V drug if PRA<

0.65;

prescribing a second R drug if 0.65≦

PRA<

6.5; and

switching the V drug to a second R drug if PRA≧

6.5.

7. The method of claim 6, wherein before performing the method on patients with a PRA≧

1.6, on the second visit, ruling out renovascular hypertension by tests selected from the group consisting of a captopril test, a renal vein sampling and a renal angiogram or combinations thereof.

8. The method of claim 6, wherein before performing the method on patients with a PRA<

0.65, ruling out primary aldosteronism by tests selected from the group consisting of a hypokalemia test, a 24 hr. urine aldosterone test, an adrenal CT scan and adrenal vein sampling and combinations thereof.

9. A method of treating hypertensive patients who have not adequately responded to previous treatment using V drugs, R drugs or V and R drugs together when they visit a physician, clinic or hospital, comprising:

on the first visit, drawing blood from each patient for a plasma renin activity (PRA) test;

on the second visit;

if PRA<

0.65, then;

if a patient was taking a V drug, then follow a V treatment;

if a patient was taking an R drug, then switch to a V drug and if the BP is still not adequately controlled, then follow a V treatment;

if a patient was taking a V drug and an R drug, then follow a Secondary treatment;

if 0.65≦

PRA<

6.5, then;

if a patient was taking a V drug, then follow a V treatment;

if a patient was taking an R drug, then follow an R treatment;

if a patient was taking a V drug and an R drug, then follow a Secondary treatment;

if PRA≧

6.5, then;

if a patient was taking a V drug, then switch to a low dose R drug and if the BP is not adequately controlled, follow an R treatment;

if a patient was taking an R drug, then follow an R treatment;

if a patient was taking a V drug and an R drug, then follow a Secondary treatment;

wherein the V treatment comprises;

increasing the dose of the V drug if the V drug was being taken at a low dose, otherwise prescribing a low dose R drug in addition to the V drug;

measuring the BP and if the BP is still not adequately controlled, increasing the dose of the R drug-and following the Secondary treatment;

wherein the R treatment comprises;

increasing the dose of the R drug if the R drug was being taken at a low dose, otherwise prescribing a low dose V drug in addition to the R drug;

measuring the BP and if the BP is not adequately controlled, increasing the dose of the V drug and following the Secondary treatment;

wherein the Secondary treatment comprises measuring the BP and if the BP is not adequately controlled, then;

switching the R drug to a second V drug if the PRA<

0.65;

prescribing a second R drug if 0.65≦

PRA<

6.5;

or

switching the V drug to a second R drug if PRA≧

6.5.

13. A method of treating a hypertensive patient having a PRA less than about 0.65 ng/ml/hr comprising:

a. administering to the patient a low dose V drug;

b. after step (a) measuring the patient'"'"'s BP and if the patient'"'"'s BP is not controlled, administering to the patient an increased dose of the V drug;

c. after step (b) measuring the patient'"'"'s BP and if the patient'"'"'s BP is not controlled, administering to the patient an R drug in addition to the V drug.

14. The method of claim 13 further comprising:

after step (c) measuring the patient'"'"'s BP and if the patient'"'"'s BP is not controlled, administering to the patient an increased dose of the R drug in addition to the V drug.

15. The method of claim 14 further comprising measuring the patient'"'"'s PRA.

16. The method of claim 15 further comprising administering to the patient a second V drug and ceasing administration of the R drug if the patient'"'"'s PRA is less than about 0.65.

17. The method of claim 15 further comprising administering to the patient a second R drug if the patient'"'"'s PRA is between about 0.65 and about 6.5.

18. The method of claim 15 further comprising administering to the patient a second R drug and ceasing administration of the V drug if the PRA is greater than about 6.5.

19. A method of treating a hypertensive patient having a PRA greater than or equal to about 0.65 ng/ml/hr comprising:

a. administering to the patient a low dose R drug;

b. after step (a) measuring the patient'"'"'s BP and if the patient'"'"'s BP is not controlled, administering to the patient an increased dose of the R drug; and

c. after step (b) measuring the patient'"'"'s BP and if the patient'"'"'s BP is not controlled, administering to the patient a V drug in addition to the R drug.

20. The method of claim 19 comprising:

after step (c) measuring the patient'"'"'s BP and if the patient'"'"'s BP is not controlled, administering to the patient an increased dose of the V drug in addition to the R drug.

21. The method of claim 20 further comprising measuring the patient'"'"'s PRA.

22. The method of claim 21 further comprising administering to the patient a second V drug and ceasing administration of the R drug if the patient'"'"'s PRA is less than about 0.65.

23. The method of claim 21 further comprising administering to the patient a second R drug if the patient'"'"'s PRA is inclusively between about 0.65 and about 6.5.

24. The method of claim 21 further comprising administering to the patient a second R drug and ceasing administration of the V drug if the patient'"'"'s PRA is greater than about 6.5.

25. A method for treating patients with hypertension who have a medium to high level plasma renin activity (PRA), comprising:

A. prescribing an R drug at a low dose;

B. increasing the dose of the R drug if a patient'"'"'s blood pressure (BP) is not adequately controlled after A;

C. prescribing a V drug at a low dose in addition to the R drug if a patient'"'"'s BP is not adequately controlled after B;

D. increasing the dose of the V drug if a patient'"'"'s BP is not adequately controlled after C, and measuring the PRA;

E. if the BP is not adequately controlled after D, then;

i. switching the R drug to a second V drug if is at a low level;

ii. prescribing a second R drug if PRA is at a medium level; and

iii. switching the V drug to a second R drug if PRA is at a high level.

26. A method for treating patients with hypertension who have a low level plasma renin activity (PRA), comprising:

A. prescribing a V drug at a low dose;

B. increasing the dose of the V drug if a patient'"'"'s blood pressure (BP) is not adequately controlled after A;

C. prescribing an R drug at a low dose in addition to the V drug if a patient'"'"'s BP is not adequately controlled after B;

D. increasing the dose of the R drug if a patient'"'"'s BP is not adequately controlled after C, and measuring the PRA;

E. if the BP is not adequately controlled after D, then;

i. switching the R drug to a second V drug if PRA is at a low level;

ii. prescribing a second R drug if PRA is at a medium level; and

iii. switching the V drug to a second R drug if PRA at a high level.