Chemistry: analytical and immunological testing – Lipids – triglycerides – cholesterol – or lipoproteins
Reexamination Certificate
2001-11-14
2003-06-10
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Lipids, triglycerides, cholesterol, or lipoproteins
C436S013000, C436S016000, C436S173000
Reexamination Certificate
active
06576471
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to analysing and reporting patient specific medical information.
BACKGROUND OF THE INVENTION
Recently, a significant advance in measurement techniques used to analyze blood plasma lipoprotein samples was achieved. Lipoproteins are the spherical particles that transport cholesterol, triglycerides, and other lipids in the bloodstream. The advanced measurement technique employs NMR spectroscopy to provide additional (higher-order) patient-specific information over the types of information typically provided under routine conventional analysis methods. See U.S. Pat. No. 4,933,844 to Otvos, entitled “
Measurement of Blood Lipoprotein Constituents by Analysis of Data Acquired From an NMR Spectrometer
” and U.S. Pat. No. 5,343,389 to Otvos, entitled “
Method and Apparatus for Measuring Classes and Subclasses of Lipoproteins
.” The contents of these documents are hereby incorporated by reference as if recited in full herein. Unlike conventional “routine” laboratory lipoprotein blood tests, the lipoprotein analysis provided by the NMR spectral analysis now more easily provides lipoprotein subclass information, which had, until this advance, been generally inaccessible to clinicians. This subclass information can provide information corresponding to the sizes of the lipoprotein particles that make up a person's lipoprotein constituents.
Lipoprotein subclass information is not included in conventional commercially prepared lipid panels. The conventional panels typically only provided information concerning total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol (generally a calculated value), and high-density lipoprotein (HDL) cholesterol. In contrast, the NMR analysis can provide information about (a) the concentrations of six subclasses of very low density lipoprotein (VLDL), four subclasses of LDL (including intermediate-density IDL), and five subclasses of HDL, (b) average LDL particle size (which can be used to categorize individuals into LDL subclass pattern-determined risk), and (c) LDL particle concentration.
The subclass information now available with the NMR spectral analysis can be a more reliable indicator of a patient's risk to develop coronary heart disease. Indeed, recent scientific research has shown that various subclasses of lipoproteins may provide more reliable markers of the metabolic conditions that predispose individuals to a greater or lesser risk of heart disease. However, the NMR spectral analysis can also provide higher-order information about the levels of variously atherogenic or antiatherogenic subclasses that make up each of the major lipoprotein classes.
This subclass information can provide a clear indication about a patient's propensity to develop coronary heart disease. Unfortunately, this additional information can confuse a reviewer as to the meaning of the data, and further, the additional information can be difficult to analyze in a readily discernable manner. For example, a typical NMR lipoprotein analysis can include at least fifteen more values of lipoprotein concentration and size than is provided by standard lipoprotein panels. There is, therefore, a need to analyze and present the lipoprotein-based information in a manner or format which is visually easy to read and understand and which provides a useful coronary heart disease risk assessment.
OBJECTS AND SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a method to analyze patient-specific NMR based lipoprotein measurements in a manner which yields a reliable indicator of an associated risk of developing coronary heart disease.
It is an additional object of the present invention to provide a lipoprotein profile analysis with subclass information with an easily read display format.
It is also an object of the present invention to provide a lipoprotein-based risk assessment which analyzes a patient's measured major lipoprotein constituent values and/or selected subclass information and presents them in a format in which a patient's specific values are presented in a reader-friendly format.
It is a further object of the present invention to provide a method of generating a customized report at a commercial volume and which can analyze and/or report a patient's risk factors for coronary heart disease based on NMR-based measurements of lipoprotein constituents.
It is still another object of the invention to alert the patient or physician of a reduced lipoprotein constituent value for a secondary prevention goal for patients with underlying metabolic disorders.
It is an additional object of the present invention to provide a system for measuring lipoprotein constituents and analyzing the constituent values in a manner which determines CHD risk.
These and other objects of the present invention are provided by a method for identifying a patient with an increased risk of coronary heart disease by analyzing the patient's NMR lipoprotein constituent measurements. This analysis includes determining a risk for a specific constituent identified as having an independently predictive factor (in isolation of the other constituent values) and for a combination of certain of the constituent measurement values. Preferably, the combination method identifies whether the patient's results provide a positive match with two key NMR measured lipoprotein factors. The first factor is the determination of the presence of atherogenic dyslipidemia (i.e., a clustering of predetermined level moderate, borderline, or positive NMR subclass or constituent based risk values) and the second factor is the detection of an elevated number of NMR measured LDL particles. Advantageously, this type of risk analysis is typically more accurate than the plasma apo B level techniques used in the past, and can provide a more reliable indictor as it more closely corresponds to a patient's true lipoprotein composition.
In particular, a first aspect of the present invention is directed to a method for assessing a patient's risk of coronary heart disease based on personalized NMR measured lipoprotein-based information. The method includes generating NMR-based lipoprotein measurement values for a patient's blood plasma or serum sample, the NMR-based lipoprotein measurement values comprising a plurality of lipoprotein constituent values including a constituent value for LDL particle concentration. The LDL particle concentration is compared with predetermined test criteria for determining whether the LDL particle concentration is elevated and a plurality of NMR-based lipoprotein constituent values are compared to predetermined test criteria to determine the presence of atherogenic dyslipidemia. A patient's risk of coronary heart disease is assessed based on one or more of the LDL particle elevated concentration level and the presence (or absence) of atherogenic dyslipidemia.
In a preferred embodiment, the NMR-based lipoprotein constituent values include the major lipoprotein constituents of total cholesterol, LDL concentration in cholesterol equivalents, HDL concentration in cholesterol equivalents, and triglycerides, and the measured lipoprotein constituent values also include the values associated with LDL size, LDL particles, large HDL cholesterol, and large VLDL triglyceride. It is also preferred that the NMR based lipoprotein constituent values used to determine the presence of atherogenic dyslipidemia is independent to the LDL particle concentration value (i.e., does not include the isolated LDL particle concentration value as part of the subtest criteria for determining atherogenic dyslipidemia). Preferably, the predetermined test criteria for determining the presence of an elevated number of LDL particles is set at a value which is in about the upper 50% of the population (at least moderately elevated). Of course, the presence of atherogenic dyslipidemia when an elevated LDL particle concentration also exists is particularly indicative of the presence of a higher
Gakh Yelena
LipoScience, Inc.
Myers Bigel & Sibley Sajovec, PA
Warden Jill
LandOfFree
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