Treating chronic uremic patients undergoing periodical dialysis

• US 6,914,076 B2
• Filed: 12/01/2003
• Issued: 07/05/2005
• Est. Priority Date: 01/19/2000
• Status: Expired due to Term

• Current Assignee: Alfasigma S.p.A.
• Original Assignee: Sigma-Tau Industrie Farmaceutiche Riunite SPA (Alfasigma S.p.A.)
• Inventors: Cavazza, Claudio
• Primary Examiner(s): Henley, III, Raymond J.
• Application Number:
  US10/724,175
• Publication Number:
  US 20040110836A1
• Time in Patent Office: 582 Days
• Field of Search: 514/556
• US Class Current: 514/556
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine

Abstract

The method for the treatment of chronic uremic patients undergoing periodical dialysis is useful for preventing and/or treating carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. The method according to the present invention comprises administering an effective dose of carnitine intravenously into the venous return line after each dialysis session.

Claims

1. A method of preventing or treating carnitine deficiency in chronic uremic patients undergoing periodic dialysis comprising administering to the patient at the conclusion of the dialysis into a venous return line after a dialysis session from about 10 to about 20 mg/kg body weight of carnitine, calculated as L-carnitine or a pharmaceutically acceptable salt thereof wherein the treatment is repeated twice a week every 44 hours, then after 68 hours.

2. The method of claim 1, wherein the treatment is continued for 3-4 weeks, monitoring pre-dialytic levels of carnitine.

3. The method of claim 2, wherein pre-dialytic levels of carnitine are equal to lower than 40-50 μ

M.

4. The method of claim 1, wherein a maintenance dosage is provided, administering a dose of 5 mg/kg of carnitine.

5. The method of claim 1, wherein carnitine fumarate is the pharmaceutically acceptable salt.

6. The method of claim 5, wherein the patient is affected by hypervolemic heart.

7. The method of claim 5, wherein the patient is affected by diabetes.

8. A method of preventing or treating carnitine deficiency in chronic uremic patients undergoing periodic dialysis comprising administering to the patient at the conclusion of the dialysis into a venous return line after a dialysis session an amount of L-carnitine or of a pharmaceutically acceptable salt thereof effective to restore a level of carnitine in the patient to a pre-dialytic level, and thereafter reducing the amount of carnitine administered to a level sufficient to maintain carnitine levels to the pre-dialytic level.

12. The method of claim 8 or 9, wherein pre-dialytic levels of carnitine are equal or lower than 40-50 μ

M.

13. The method of claim 8 of 9, wherein a maintenance dosage of about 5 mg/kg of carnitine is administered.

9. A method of preventing or treating carnitine deficiency in chronic uremic patients undergoing periodic dialysis comprising administering to the patient at the conclusion of the dialysis into a venous return line after a dialysis session from about 10 to about 20 mg/kg body weight of carnitine, calculated as L-carnitine, or of a pharmaceutically acceptable salt thereof to restore a level of carnitine in the patient to a pre-dialytic level, and thereafter reducing the amount of carnitine administered to a level sufficient to maintain carnitine levels to the pre-dialytic level.

10. The method of claim 9 wherein the treatment to achieve pre-dialytic levels is on a weekly basis repeated twice a week every 44 hours, then after 68 hours.

11. The method of claim 10, wherein the treatment is continued for 3-4 weeks.