Pharmaceutical composition, methods for treating and uses thereof
The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 , wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m 2 .
2. The method according to claim 1 , wherein empagliflozin is administered in a total daily amount of 5 mg.
3. The method according to claim 1 , wherein empagliflozin is administered in a total daily amount of 10 mg.
4. The method according to claim 1 , wherein empagliflozin is administered in a total daily amount of 12.5 mg.
5. The method according to claim 1 , wherein empagliflozin is administered in a total daily amount of 25 mg.
6. The method according to claim 1 , further comprising administering metformin to the patient.
7. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising:
a) assessing the renal function of a patient;
b) administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 , wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg,
wherein the glycemic control in said patient is improved;
c) discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m 2 .
8. The method according to claim 7 , wherein empagliflozin is administered in a total daily amount of 5 mg.
9. The method according to claim 7 , wherein empagliflozin is administered in a total daily amount of 10 mg.
10. The method according to claim 7 , wherein empagliflozin is administered in a total daily amount of 12.5 mg.
11. The method according to claim 7 , wherein empagliflozin is administered in a total daily amount of 25 mg.
12. The method according to claim 7 , further comprising administering metformin to the patient.
13. A method of treating type 2 diabetes mellitus in a patient comprising administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 , wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m 2 .
14. The method according to claim 13 , wherein empagliflozin is administered in a total daily amount of 5 mg.
15. The method according to claim 13 , wherein empagliflozin is administered in a total daily amount of 10 mg.
16. The method according to claim 13 , wherein empagliflozin is administered in a total daily amount of 12.5 mg.
17. The method according to claim 13 , wherein empagliflozin is administered in a total daily amount of 25 mg.
18. The method according to claim 13 , further comprising administering metformin to the patient.
19. A method of treating type 2 diabetes mellitus comprising:
a) assessing the renal function of a patient with type 2 diabetes mellitus;
b) administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m 2 and <60 ml/min/1.73 m 2 , wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved;
c) discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m 2 .
20. The method according to claim 19 , wherein empagliflozin is administered in a total daily amount of 5 mg.
21. The method according to claim 19 , wherein empagliflozin is administered in a total daily amount of 10 mg.
22. The method according to claim 19 , wherein empagliflozin is administered in a total daily amount of 12.5 mg.
23. The method according to claim 19 , wherein empagliflozin is administered in a total daily amount of 25 mg.
24. The method according to claim 19 , further comprising administering metformin to the patient.