Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2001-05-17
2003-07-22
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
C600S483000, C600S300000, C424S009100, C424S009200
Reexamination Certificate
active
06595926
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to new and useful methods for the evaluation and treatment of hypertension.
BACKGROUND INFORMATION
Hypertension is a sustained elevation of blood pressure that can lead to heart attack, heart or kidney failure, stroke, and other cardiovascular diseases. Hypertension affects about 20% of the population worldwide. A major problem is that the current methods that are widely used for the detection and treatment of hypertension are inadequate and result in enormous personal suffering and economic costs.
The Economic Costs of Hypertension
The 1999 Annual Report of the American Heart Association estimates the direct cost of hypertension in the United States to be $26.1 billion annually, plus an additional $11.1 billion in indirect costs arising from lost productivity due to morbidity and mortality (Table 1). Moreover, the link between hypertension and other cardiovascular diseases has become increasingly evident.
TABLE 1
Economic Costs of Hypertension in the U.S. ($ Billion)
Conges-
Total
Coronary
tive
Cardio-
Heart
Artery
Hyper-
Heart
Vascular
Disease
Disease
Stroke
tension
Failure
Disease
Direct Costs
Hospital/Nursing
$78.9
$42.0
$25.0
$7.4
$15.5
$128.4
Home
Physicians/Other
14.4
8.1
2.3
8.1
1.5
28.2
Professionals
Drugs
7.3
3.5
0.4
9.0
1.1
17.7
Home Health/Other
5.2
1.6
2.9
1.6
2.2
11.5
Medical Durables
Total
$105.9
$55.2
$30.6
$26.1
$20.3
$185.8
Indirect Costs
Lost
17.2
7.2
5.6
5.2
NA
27.6
Productivity/Morbidity
Lost
91.6
55.8
15.1
5.9
2.2
113.2
Productivity/Mortality
Grand Total
$214.7
$118.2
$51.3
$37.2
$22.5
$326.6
Source: American Heart Association 1999 Annual Report
Number Affected and the Low Rate of Treatment Success
It is estimated that in the United States alone there are about 50 million hypertensives, of whom only about 68% have had their hypertension diagnosed (Table 2). Among the estimated 34.2 million identified hypertensives receiving medical treatment, only 27% have their blood pressure adequately controlled. A more conservative estimate suggests that this rate may be as low as 12%, and in other countries, the treatment success rates may be even lower: 12% in France, and 9% in Britain. Moreover, the available data indicate that the success rate of treatment has actually fallen during the past several years, despite the availability of new and powerful antihypertensive medications.
Poor success rates in the management of hypertensive patients have resulted from empirical approaches to selecting antihypertensive drugs. This empirical approach is recommended by.authorities, and followed by many Physicians. For example, in the United States, the Joint National Committee (JNC) on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure periodically surveys the literature and current knowledge on hypertension. The current recommendation of the JNC (JNC VI) is to use a diuretic or a &bgr;-blocker—among the oldest classes of antihypertensive drugs—as a first line treatment.
The recommendations of the JNC VI are based on a traditional epidemiological model in their evaluation of hypertension treatment. In this model, hypertension is assumed to be a single process disease in which all patients have a common pathophysiological mechanism. When blood pressure does not decrease in response to empirical treatments with either diuretics or &bgr;-blockers or both, several different drug types are added until blood pressure is subdued. This empirical approach to treatment is referred to as “stepped care”. Stepped care results in many patients being treated with at least two different antihypertensive drug types. This approach tends to increase the long term expense of treatment and to promote more adverse side effects. Perhaps consequently, only a small proportion of patients complies with their antihypertensive drug regimen, which further reduces the possibility of achieving blood pressure control. For example, a recent study in California showed that only 6% of the hypertensive Medicaid population adhere to their drug treatment regimens.
TABLE 2
Detection and Treatment of Hypertension in the US
1988-1991
1991-1994
Awareness
73%
68%
Treatment
55%
54%
Control
29%
27%
Source: Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI)
Therefore, a great need exists for methods to successfully evaluate and treat hypertensive patients in order to reduce both the enormous cost associated with hypertension, and consequential costs of cardiovascular diseases, which is estimated at about 15% of the $1.2 trillion annual US Health Care bill.
SUMMARY OF THE INVENTION
The present invention discussed herein provides novel methods or systems—the Laragh Method—for evaluating and treating hypertensive patients. The Laragh Method provides a systematic approach that allows physicians and other health care providers to select the appropriate treatment, tailored to suit each individual hypertensive patient. The Laragh Method greatly improves the therapeutic success rate among hypertensive patients and uses more rational drug selection as compared to the traditional, empirical “stepped care” approach.
The stepped care approach is conceptually flawed because it fails to recognize the heterogeneity of biochemical mechanisms involved among different hypertensive patients. The Laragh Method incorporates the concept that high blood pressure, like fever, is a physical sign that has several identifiable causes and underlying abnormal mechanisms. Just as fever cannot be appropriately treated with a single recipe, neither should hypertension.
Unlike the recommendations of the JNC, which are based partly on the preconception of a single process and other epidemiological considerations, the Laragh Method evaluates and treats the identifiable pathogenic mechanisms that caused blood pressure to rise in the individual patient in the first place.
The Laragh Method can be used to evaluate and treat previously untreated hypertensive patients as well as patients who have undergone or are receiving unsuccessful treatments. In addition, the Laragh Method may be used to evaluate and treat hypertensive crises.
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Blumenfeld, Jon D., et al. “Plasma Renin Activity in the Emergency Department and Its Independent Association With Acute Myocardial Infarction,” American Journal of Hypertension, Ltd. 2000, 855-863, Elsevier Science.
Laragh, John H., “The Role of Biochemical Markers in the Assessment and Management of Hypertension,” 1994, Planned and Produced in accordance with the ACCME Essentials on Enduring Materials.
Blumenfeld, Jon D., et al. “Renin System Analysis: A Rational Method for the Diagnosis and Treatment of the Individual Patient With Hypertension,” American Journal of Hypertension, 1998, Elsevier Science.
Trilling, Jeffrey S., et al, “The Urgent Need to Improve Hypertension Care,” Archives of Family Medicine, 2000, 794-801, vol. 9 No. 9.
Hindenburg Max F.
Kramer Levin Naftalis & Frankel LLP
Natnithithadha Navin
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