Personalized medicine management software

• US 8,380,539 B2
• Filed: 05/08/2007
• Issued: 02/19/2013
• Est. Priority Date: 05/09/2006
• Status: Active Grant

• Current Assignee: University of Louisville
• Original Assignee: University of Louisville
• Inventors: Linder, Mark W., Valdes, Roland Jr.
• Primary Examiner(s): O'Connor, Gerald J.
• Assistant Examiner(s): Ng, Jonathan K
• Application Number:
  US12/300,104
• Publication Number:
  US 20090138286A1
• Time in Patent Office: 2,114 Days
• Field of Search: 705/2, 705/3, 600/300, 435/6
• US Class Current: 705/3
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

The invention provides personalized medicine management software for determining a series of recommended doses of a medication for a patient. The software contains code to receive information regarding a combination of at least one genetic factor and personal attributes for the patient that are predictive of the patient'"'"'s reaction to a series of doses of the medication. Using a predictive mathematical model specific to the medication, the code calculates the series of recommended doses specific to the patient'"'"'s genetic factor and personal attributes and specific to the medication. The series of recommended doses is outputted. In preferred embodiments, the output is the form of an interactive display. The interactive display permits a user, typically a health care professional, to input actual doses and actual patient responses. The subsequent series of recommended doses is preferably then adjusted, in real time, to account for the actual doses and actual patient responses.

Claims

1. Personalized medicine management software stored on a non-transitory computer medium for causing a computer to determine a series of a recommended doses of an anticoagulant medication for a patient, the software containing code for causing a computer to conduct the following steps:

receiving information regarding a combination of the genotypes of VKORC1 and CYP2C9 and personal attributes for the patient that are predictive of the patient'"'"'s reaction to a series of doses of the anticoagulant medication;

with a predictive mathematical model specific to the medication, calculating a series of recommended doses specific to the patient'"'"'s at least one genetic factor and personal attributes specific to the medication, wherein the model predicts maintenance dose series based upon the patient'"'"'s VKORC1 and CYP2C9 and a calculated clearance of the anticoagulant medication;

receiving actual dose and measured patient response data and adjusting the patient'"'"'s calculated clearance of the medication based on CYP2C9 genotype and a target blood concentration required for optimal therapeutic response that is adjusted based on the VKORC1;

graphically displaying a representation of dosing and concentration, wherein the representation graphically represents time for blood concentrations of the anticoagulant medication to achieve or transition to a steady-state for a given dosing, and wherein the graphic dosing rate is changed in response to said step of receiving and wherein the graphical representation of anticoagulant medication concentrations in blood are plotted in conjunction with measured medication response to add temporal dimension to the interpretation of the medication response parameter; and

wherein the representation that is graphically displayed includes overlays of anticoagulant medication concentration, measured medication response, and dosing over time and wherein the representation is updated in real time after said step of receiving.

2. The software of claim 1, wherein the measured medication response is INR.

3. The software of claim 2, further comprising a step of recording and storing, separately for each patient and for each anticoagulant medication, data concerning the anticoagulant medication concentration, INR and dosing over time.

4. The software of claim 1, wherein said step of calculating comprises applying a mathematical regression model to determine the patient'"'"'s optimal series of recommended doses.

5. The software of claim 1, wherein the personal attributes of the patient are selected from the group consisting of gender, height, weight, age, race, co-medications, and ingested materials.

6. The software of claim 1, wherein the anticoagulant medication comprises warfarin.

7. The software of claim 1, wherein the mathematical model further estimates a target plasma concentration required during therapy.

8. The software of claim 7, wherein the plasma concentration is determined by the mathematical model based on the VKORC1 genotype.