IP Library Granted Patent US 8,518,895
Granted Patent B2
US 8,518,895 · App. 12/993,766 · Granted Aug 27, 2013

Method for treating hyponatremia employing an SGLT2 inhibitor and composition containing same

Inventors: Bruce Robert Leslie (Princeton, NJ); Mitchell Halperin (Princeton, NJ)
Assignee: Bristol-Myers Squibb Company
A61K31/7034C07H7/04
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Quick Facts
Patent No.
US 8,518,895
App. No.
12/993,766
Granted
Aug 27, 2013
Kind
B2
Abstract

Methods are provided for treating hyponatremia, employing an SGLT2 inhibitor alone, or in combination with a supply of carbohydrate, and/or in combination with a diuretic agent. Additionally, compositions comprising an SGLT2 inhibitor, optionally with a supply of carbohydrate, and/or a combination of an SGLT2 inhibitor and a diuretic agent are provided in the instant invention and are provided for use in the inventive methods.

Claims (27)

1. A method for treating hyponatremia in a mammal, the hyponatremia being associated with reduced plasma osmolality, the method comprising administering to the mammal in need of such treatment a therapeutically effective amount of a sodium glucose transporter 2 (SGLT2) inhibitor, wherein the SGLT2 inhibitor is

or a prodrug ester thereof or a propylene glycol solvate thereof.

2. The method according to claim 1 , wherein the hyponatremia is chronic hyponatremia.

3. The method according to claim 1 , said method further comprising administering to the mammal a supply of carbohydrate, wherein the supply of carbohydrate is administered before, after, or concurrently with the SGLT2 inhibitor.

4. The method according to claim 1 , wherein plasma sodium concentration of the mammal is below 135 mmol/L.

5. A method for treating hyponatremia in a mammal suffering from water intoxication, the method comprising administering to the mammal in need of such treatment a therapeutically effective amount of a sodium glucose transporter 2 (SGLT2) inhibitor, wherein the SGLT2 inhibitor is

or a prodrug ester thereof or a propylene glycol solvate thereof.

6. The method according to claim 1 , wherein the mammal suffers from water retention.

7. The method according to claim 1 , further comprising administering to the mammal a diuretic agent wherein the diuretic agent is administered before, after, or concurrently with the SGLT2 inhibitor.

8. The method according to claim 1 , wherein the diuretic agent is an anti-diuresis hormone (ADH) antagonist.

9. The method according to claim 1 , wherein the SGLT2 inhibitor is administered in an amount sufficient to reduce hyponatremia without inducing hypoglycemia.

10. The method according to claim 1 wherein the SGLT2 inhibitor is

11. The method according to claim 1 , wherein the administration of the SGLT2 inhibitor treats the hyponatremia by increasing urine volume.

12. A method for treating hypervolemic hyponatremia in a mammal, the method comprising administering to the mammal in need of such treatment a therapeutically effective amount of a sodium glucose transporter 2 (SGLT2) inhibitor, wherein the SGLT2 inhibitor is

or a prodrug ester thereof or a propylene glycol solvate thereof, wherein the administration of the SGLT2 inhibitor treats the hyponatremia by increasing urine volume.

13. A method for treating hyponatremia in a mammal not suffering from hyperglycemia, the method comprising administering to the mammal in need of such treatment a therapeutically effective amount of a sodium glucose transporter 2 (SGLT2) inhibitor, wherein the SGLT2 inhibitor is

or a prodrug ester thereof or a propylene glycol solvate thereof.

14. The method according to claim 3 , wherein the supply of carbohydrate is administered concurrently with the SGLT2 inhibitor at a rate in the range of about 30 to about 270 g concurrently-administered carbohydrate per day.

15. The method according to claim 5 wherein the SGLT2 inhibitor is

16. The method according to claim 5 , wherein plasma sodium concentration of the mammal is below 135 mmol/L.

17. The method according to claim 5 , wherein the SGLT2 inhibitor is administered in an amount sufficient to reduce hyponatremia without inducing hypoglycemia.

18. The method according to claim 12 wherein the SGLT2 inhibitor is

19. The method according to claim 12 , wherein plasma sodium concentration of the mammal is below 135 mmol/L.

20. The method according to claim 12 , wherein the SGLT2 inhibitor is administered in an amount sufficient to reduce hyponatremia without inducing hypoglycemia.

21. The method according to claim 13 wherein the SGLT2 inhibitor is

22. The method according to claim 13 , wherein plasma sodium concentration of the mammal is below 135 mmol/L.

23. The method according to claim 13 , wherein the SGLT2 inhibitor is administered in an amount sufficient to reduce hyponatremia without inducing hypoglycemia.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE ADDRESS PREVIOUSLY RECORDED ON REEL 032541 FRAME 0698. ASSIGNOR(S) HEREBY CONFIRMS THE ADDRESS OF THE ASSIGNEE SHOULD BE SE-151 85, SODERTALJE, SWEDEN. Recorded May 9, 2014
From: BRISTOL-MYERS SQUIBB COMPANY
To: ASTRAZENECA AB
Reel/Frame 032858/0978 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 27, 2014
From: BRISTOL-MYERS SQUIBB COMPANY
To: ASTRAZENECA AB
Reel/Frame 032541/0698 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 7, 2011
From: LESLIE, BRUCE ROBERT; HALPERIN, MITCHELL
To: BRISTOL-MYERS SQUIBB COMPANY
Reel/Frame 025599/0507 →
Continuity (2)
Provisional Application 61055448 · May 22, 2008
Related Publication 20110077214A1 · Mar 31, 2011