# US 7,608,393 B2 · Methods of predicting a benefit of antioxidant therapy for prevention of cardiovascular disease in hyperglycemic patients

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- Number: US 7,608,393 B2
- Document ID: US7608393B2
- Status: Granted
- Kind: B2
- Application number: 10/748,177
- Filed: 2003-12-31
- Published: 2004-11-18
- Granted: 2009-10-27
- Earliest claimed: 2000-04-20
- Assignees: Rappaport Family Institute for Research in the Medical Sciences
- Inventors: Andrew P. Levy
- Web page: https://patentgrep.com/patent/US7608393B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- G01N 33/6893: {related to diseases not provided for elsewhere}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- G01N 2800/32: Cardiovascular disorders
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A method of determining a potential of a diabetic patient to benefit from anti oxidant therapy for treatment of a vascular complication, the method comprising determining a haptoglobin phenotype of the diabetic patient and thereby determining the potential of the diabetic patient to benefit from said anti oxidant therapy, whereby a patient having a haptoglobin 2-2 phenotype benefits from anti oxidant therapy more than a patient having a haptoglobin 1-2 phenotype or a patient having a haptoglobin 1-1 phenotype.

## Claims

### Claim 1

A method of determining a potential of a diabetic patient over 55 years of age to benefit from vitamin E therapy for prevention of myocardial infarction, the method comprising determining a haptoglobin phenotype of the diabetic patient and thereby determining the potential of the diabetic patient to benefit from said vitamin E therapy, wherein said benefit from said vitamin E therapy to a patient having a haptoglobin 2-2 phenotype is greater compared to patients having haptoglobin 1-2 phenotype or haptoglobin 1-1 phenotypes.

### Claim 2 (depends on 1)

The method of claim 1, wherein said determining said haptoglobin phenotype is effected by directly determining the haptoglobin phenotype of the diabetic patient.

### Claim 3 (depends on 2)

The method of claim 2, wherein step of determining said haptoglobin phenotype is effected by an immunological detection method.

### Claim 4 (depends on 3)

The method of claim 3, wherein said immunological detection method is selected from the group consisting of a radio-immunoassay (RIA), an enzyme linked immunosorbent assay (ELISA), a western blot, an immunohistochemical analysis, and fluorescence activated cell sorting (FACS).

### Claim 5 (depends on 1)

The method of claim 1, wherein said determining said haptoglobin phenotype is effected by determining a haptoglobin genotype of the diabetic patient.

### Claim 6 (depends on 5)

The method of claim 5, wherein said step of determining said haptoglobin genotype of the diabetic patient is effected by a method selected from the group consisting of a signal amplification method, a direct detection method and detection of at least one sequence change.

### Claim 7 (depends on 6)

The method of claim 6, wherein said signal amplification method is selected from the group consisting of PCR, LCR (LAR), Self-Sustained Synthetic Reaction (3R/NASBA) and Q-Beta (Qβ) Replicase reaction.

### Claim 8 (depends on 6)

The method of claim 6, wherein said direct detection method is selected from the group consisting of a cycling probe reaction (CPR) and a branched DNA analysis.

### Claim 9 (depends on 6)

The method of claim 6, wherein said detection of at least one sequence change employs a method selected from the group consisting of restriction fragment length polymorphism (RFLP analysis), allele specific oligonucleotide (ASO) analysis, Denaturing/Temperature Gradient Gel Electrophoresis (DGGE/TGGE), Single-Strand Conformation Polymorphism (SSCP) analysis and Dideoxy fingerprinting (ddF).

### Claim 10 (depends on 6)

The method of claim 6, wherein said signal amplification method amplifies a molecule selected from the group consisting of a DNA molecule and an RNA molecule.

### Claim 11

A method of determining the importance of reducing oxidative stress by administering vitamin E in a diabetic patient over 55 years of age so as to prevent myocardial infarction, the method comprising the step of determining a haptoglobin phenotype of the diabetic patient thereby determining the importance of reducing the oxidative stress by administering vitamin E in the specific diabetic patient, wherein said importance of reducing oxidative stress by administering vitamin E is greater in a patient having a haptoglobin 2-2 phenotype compared to patients having haptoglobin 1-2 phenotype or haptoglobin 1-1 phenotypes.

### Claim 12 (depends on 11)

The method of claim 11, wherein said step of determining said haptoglobin phenotype is effected by directly determining the haptoglobin phenotype of the diabetic patient.

### Claim 13 (depends on 12)

The method of claim 12, wherein said step of determining said haptoglobin phenotype is effected by an immunological detection method.

### Claim 14 (depends on 13)

The method of claim 13, wherein said an immunological detection method is selected from the group consisting of a radio-immunoassay (RIA), an enzyme linked immunosorbent assay (ELISA), a western blot, an immunohistochemical analysis, and fluorescence activated cell sorting (FACS).

### Claim 15 (depends on 11)

The method of claim 11, wherein said determining said haptoglobin phenotype is effected by determining a haptoglobin genotype of the diabetic patient.

### Claim 16 (depends on 15)

The method of claim 15, wherein said step of determining said haptoglobin genotype of the diabetic patient is effected by a method selected from the group consisting of a signal amplification method, a direct detection method and detection of at least one sequence change.

### Claim 17 (depends on 16)

The method of claim 16, wherein said signal amplification method is selected from the group consisting of PCR, LCR (LAR), Self-Sustained Synthetic Reaction (3R/NASBA) and Q-Beta (Qβ) Replicase reaction.

### Claim 18 (depends on 16)

The method of claim 16, wherein said direct detection method is selected from the group consisting of a cycling probe reaction (CPR) and a branched DNA analysis.

### Claim 19 (depends on 16)

The method of claim 16, wherein said detection of at least one sequence change employs a method selected from the group consisting of restriction fragment length polymorphism (RFLP analysis), allele specific oligonucleotide (ASO) analysis, Denaturing/Temperature Gradient Gel Electrophoresis (DGGE/TGGE), Single-Strand Conformation Polymorphism (SSCP) analysis and Dideoxy fingerprinting (ddF).

### Claim 20 (depends on 16)

The method of claim 16, wherein said signal amplification method amplifies a molecule selected from the group consisting of a DNA molecule and an RNA molecule.