METHODS OF TREATING HEPATIC ENCEPHALOPATHY

• US 20110071103A1
• Filed: 12/10/2010
• Published: 03/24/2011
• Est. Priority Date: 10/02/2008
• Status: Abandoned Application

• Current Assignee: Salix Pharmaceuticals Limited (Bausch Health Cos., Inc.)
• Original Assignee: Salix Pharmaceuticals Limited (Bausch Health Cos., Inc.)
• Inventors: Bortey, Enoch, Shaw, Audrey, Forbes, William, Merchant, Kunal
• Application Number:
  US12/964,847
• Publication Number:
  US 20110071103A1
• Time in Patent Office: Days
• US Class Current: 514/53
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/7016 Disaccharides, e.g. lactose, lactulose lactobionic acid A61K31/7032
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin. The instant application also provides methods for determining if a subject has a neurological condition or hepatic encephalopathy by determining the critical flicker frequency and/or the venous ammonia level of the subject at two or more time points. The invention further provides methods for treating these subjects.

Claims

1. A method of reducing the risk of hepatic encephalopathy (HE) recurrence in a subject comprising:

administering to the subject an effective amount of rifaximin, thereby reducing the risk of hepatic encephalopathy (HE) recurrence.

2. The method of claim 1, wherein the rifaximin reduces the risk of recurrence within 28 days of beginning treatment.

3. The method of claim 1, wherein the HE comprises one or more of minimal, overt, episodic, and/or persistent hepatic encephalopathy.

4. The method of claim 2, wherein the subject is diagnosed with minimal, overt, episodic, and/or persistent hepatic encephalopathy (HE).

5. The method of claim 1, further comprising administering the subject lactulose.

6. The method of claim 5, wherein the lactulose is administered prior to the rifaximin, with the rifaximin or after the rifaximin.

7. The method of claim 1, wherein the subject is administered about 1100 mg of rifaximin per day.

8. The method of claim 7, wherein the about 1100 mg of rifaximin is administered as 550 mg twice daily.

9. The method of claim 8, wherein the 550 mg of rifaximin is administered as one or more tablets or capsules.

10. The method of claim 1, wherein the subject is 18 years old or older.

11. The method of claim 1, wherein the rifaximin is administered with or without food.

12. The method of claim 1, wherein the subject has a Model for End-Stage Liver Disease (MELD) score of greater than 19.

13. The method of claim 12, wherein the MELD score is <

25.

14. The method of claim 1, wherein the method decreases the HE-related hospitalizations for the subject.

15. The method of claim 4, wherein the subject has increased exposure to rifaximin as compared to healthy subjects having been administered rifaximin.

16. The method of claim 15, wherein the subject has at least a 9.6 fold increase in rifaximin exposure.

17. The method of claim 15, wherein the subject has at least a 13.1 fold increase in rifaximin exposure.