Chemistry: analytical and immunological testing – Heterocyclic carbon compound – Hetero-n
Reexamination Certificate
2001-11-09
2004-04-13
Wallenhorst, Maureen M. (Department: 1743)
Chemistry: analytical and immunological testing
Heterocyclic carbon compound
Hetero-n
Reexamination Certificate
active
06720189
ABSTRACT:
RIGHTS OF THE GOVERNMENT
The invention described herein may be manufactured and used by or for the Government of the United States for all governmental purposes without the payment of any royalty.
BACKGROUND OF THE INVENTION
The present invention relates generally to predictive tests for determining the risk of future onset of various diseases and, in one example of the invention, a related test for determining a reduced probability for the future onset of various diseases and early all-cause mortality, and more particularly to the use of serum bilirubin tests and the serum concentration levels of serum bilirubin as risk predictors.
This invention builds on the teachings of U.S. Pat. No. 5,380,667, issued Jan. 10, 1995, to Harvey A. Schwertner, a co-inventor of the present invention, titled Serum Bilirubin and Liver Function Tests as Risk Predictors for Coronary Artery Disease, the invention description of which is incorporated by reference into this description.
U.S. Pat. No. 5,380,667 showed new non-lipid risk factors for predicting coronary heart disease, most specifically that subacute levels of serum total bilirubin are a significant independent risk predictor for coronary artery disease (CAD). The patent also showed that the ratio of total cholesterol to bilirubin may be used in place of HDL-cholesterol or the ratio of total cholesterol to HDL-cholesterol as a predictor for CAD.
The present invention is the result of additional studies involving bilirubin concentrations that reveal other predictive abilities for various diseases.
There is always a need for new risk factors and other predictive tests for disease and even, as demonstrated by one example of the present invention, for tests that may predict a lowered risk for various diseases and even a lowered risk for early onset of all-cause mortality.
It is, therefore, a principal object of the present invention to provide new risk factors and other predictive tests for disease utilizing tests for bilirubin.
It is a feature of the present invention that it uses information generally already available from tests already routinely performed.
It is another feature of the present invention that it can be used to diagnose health or the absence of disease.
It is an advantage of the present invention that it improves specificity, sensitivity and accuracy of predictive tests for various diseases.
It is another advantage of the present invention that its use will result in fewer false predictions.
It is yet another advantage of the present invention that its use will result in treatment for individuals with various diseases to begin at an earlier age.
It is a further advantage of the present invention that tests for bilirubin concentrations are easier and cheaper to perform than many other predictive tests for the same diseases.
These and other objects, features and advantages of the present invention will become apparent as the description of certain representative embodiments proceeds.
SUMMARY OF THE INVENTION
The present invention provides new risk factors for predicting the risk of various diseases. The unique discovery of the present invention is that subacute levels of serum total bilirubin is a significant independent risk predictor for various diseases.
Accordingly, the present invention is directed to a method for characterizing the risk of future cancer mortality for an individual, comprising the steps of obtaining the level of the patient's serum total bilirubin; comparing the obtained level to a predetermined level for serum total bilirubin; and, characterizing from the comparison the risk of future cancer mortality for the individual. The predetermined level of serum total bilirubin may be 0.66 mg/dl, wherein levels near or below 0.66 mg/dl indicate that the individual has a higher than normal risk of future cancer mortality.
The present invention is also directed to a method for characterizing the risk of rheumatoid arthritis for an individual, comprising the steps of obtaining the level of the individual's serum total bilirubin; comparing the obtained level to a threshold level for serum total bilirubin; and, characterizing from the comparison the risk of rheumatoid arthritis for the individual.
The present invention is further directed to a method for characterizing the reduced probability of future cardiovascular disease, future cardiovascular mortality, future cancer mortality and future all-cause mortality for an individual, comprising the steps of obtaining the level of the individual's serum total bilirubin; comparing the obtained level to a predetermined level for serum total bilirubin; and, characterizing from the comparison a reduced probability for future cardiovascular disease, future cardiovascular mortality, future cancer mortality and future all-cause mortality for the individual.
REFERENCES:
patent: 5380667 (1995-01-01), Schwertner
Lakatos et al. “Serum Total, HDL, LDL CHolesterol, and Triglyceride Levels in Patients with Rheumatoid Arthritis”, Clinical Biochemistry, vol. 21, pp. 93-96, Apr. 1988.
Fischer, Jr. Joseph R.
Schwertner Harvey A.
Kundert Thomas L.
Sinder Frederic L.
The United States of America as represented by the Secretary of
Wallenhorst Maureen M.
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