Methods and preparations for curing clinically ill patients

• US 7,446,091 B2
• Filed: 05/11/2001
• Issued: 11/04/2008
• Est. Priority Date: 05/05/2000
• Status: Expired due to Term

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Van Den Berghe, Greta
• Primary Examiner(s): KAM, CHIH MIN
• Application Number:
  US09/853,193
• Publication Number:
  US 20020107178A1
• Time in Patent Office: 2,734 Days
• Field of Search: 514/3, 514/2, 514/12, 530/303, 424/9.1
• US Class Current: 514/1.1
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 39/02 Antidotes
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/06 Antianaemics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

This invention relates to a life saving medicament for critically ill patients and a method of treatment. The composition is a pharmaceutically effective amount of a blood glucose regulator which is used to control the blood glucose level.

Claims

1. A method of treating a critically ill patient or a critically ill polyneuropathy (CIPNP) patient having a blood glucose level of greater than 130 mg/dL, said method comprising administering to said critically ill patient or CIPNP patient a blood glucose regulator selected from the group consisting of insulin, an insulin analogue, an active derivative of insulin or an insulin analogue, and a physiologically acceptable salt of said derivative in an amount effective to reduce blood glucose levels in said patient to within a range of from about 60 mg/dL to about 130 mg/dL, wherein said blood glucose regulator is administered intravenously and continuously infused to said patient as needed for at least 24 hours and the blood glucose level is maintained within a range of from about 60 mg/dL to about 130 mg/dL for 24 hours or more and wherein said treatment reduces the incidence of mortality in critically ill patients or CIPNP patients.

2. The method of claim 1 wherein the critically ill patient or CIPNP patient is a patient who has been diagnosed as having diabetes.

3. The method of claim 2, wherein the blood glucose regulator administered to said patient is Asp^B28 human insulin.

4. A method of treating a critically ill patient or a critically ill polyneuropathy (CIPNP) patient having a blood glucose level of greater than 130 mg/dL, said method comprising administering to said critically ill patient or CIPNP patient a blood glucose regulator selected from the group consisting of insulin, an insulin analogue, an active derivative of insulin or an insulin analogue, and a physiologically acceptable salt of said derivative in an amount effective to reduce blood glucose levels in said patient to within a range of from about 60 mg/dL to about 130 mg/dL, wherein said blood glucose regulator is administered intravenously and continuously infused to said patient as needed for at least 24 hours and the blood glucose level is maintained within a range of from about 60 mg/dL to about 130 mg/dL for 24 hours or more and wherein said treatment reduces the incidence of critical illness polyneuropathy in critically ill patients or CIPNP patients.

5. The method of claim 4 wherein the critically ill patient or CIPNP patient is a patient who has been diagnosed as having diabetes.

6. The method of claim 5, wherein the blood glucose regulator administered to said patient is Asp^B28 human insulin.

7. A method of treating a critically ill patient or a critically ill polyneuropathy (CIPNP) patient having a blood glucose level of greater than 130 mg/dL, said method comprising administering to said critically ill patient or CIPNP patient a blood glucose regulator selected from the group consisting of insulin, an insulin analogue, an active derivative of insulin or an insulin analogue, and a physiologically acceptable salt of said derivative in an amount effective to reduce blood glucose levels in said patient to within a range of from about 60 mg/dL to about 130 mg/dL, wherein said blood glucose regulator is administered intravenously and continuously infused to said patient as needed for at least 24 hours and the blood glucose level is maintained within a range of from about 60 mg/dL to about 130 mg/dL for 24 hours or more and wherein said treatment reduces the incidence of sepsis in critically ill patients or CIPNP patients.

8. The method of claim 7 wherein the critically ill patient or CIPNP patient is a patient who has been diagnosed as having diabetes.

9. The method of claim 8, wherein the blood glucose regulator administered to said patient is Asp^B28 human insulin.

10. A method of treating a critically ill patient or a critically ill polyneuropathy (CIPNP) patient having a blood glucose level of greater than 130 mg/dL, said method comprising administeringto said critically ill patient or CIPNP patient a blood glucose regulator selected from the group consisting of insulin, an insulin analogue, an active derivative of insulin or an insulin analogue, and a physiologically acceptable salt of said derivative in an amount effective to reduce blood glucose levels in said patient to within a range of from about 60 mg/dL to about 130 mg/dL, wherein said blood glucose regulator is administered intravenously and continuously infused to said patient as needed for at least 24 hours and the blood glucose level is maintained within a range of from about 60 mg/dL to about 130 mg/dL for 24 hours or more and wherein said treatment reduces the incidence of renal failure in critically ill patients or CIPNP patients.

11. The method of claim 10 wherein the critically ill patient or CIPNP patient is a patient who has been diagnosed as having diabetes.

12. The method of claim 11, wherein the blood glucose regulator administered to said patient is Asp^B28 human insulin.

13. A method of treating a critically ill patient or a critically ill polyneuropathy (CIPNP) patient having a blood glucose level of greater than 130 mg/dL, said method comprising administering to said critically ill patient or CIPNP patient a blood glucose regulator selected from the group consisting of insulin, an insulin analogue, an active derivative of insulin or an insulin analogue, and a physiologically acceptable salt of said derivative in an amount effective to reduce blood glucose levels in said patient to within a range of from about 60 mg/dL to about 130 mg/dL, wherein said blood glucose regulator is administered intravenously and continuously infused to said patient as needed for at least 24 hours and the blood glucose level is maintained within a range of from about 60 mg/dL to about 130 mg/dL for 24 hours or more and wherein said treatment reduces the incidence of multiple organ failure in critically ill patients or CIPNP patients.

14. The method of claim 13 wherein the critically ill patient or CIPNP patient is a patient who has been diagnosed as having diabetes.

15. The method of claim 14, wherein the blood glucose regulator administered to said patient is Asp^B28 human insulin.