IP Library › Granted Patent US 12,263,153
Granted Patent B2
US 12,263,153 · App. 17/831,460 · Granted Apr 1, 2025

Pharmaceutical composition, methods for treating and uses thereof

Inventors: Maximilian von Eynatten (Wiesbaden, DE); Uli Christian Broedl (Oakville, CA); Hans-Juergen Woerle (Grandvaux VD, CH)
Assignee: Boehringer Ingelheim International GmbH
A61K31/351A61K9/2018A61K31/7048A61K45/06A61P13/12
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Quick Facts
Patent No.
US 12,263,153
App. No.
17/831,460
Granted
Apr 1, 2025
Kind
B2
Abstract

The present invention relates to methods for treating or preventing chronic kidney disease and cardiovascular disease in patients with chronic kidney disease comprising administering empagliflozin to the patient.

Claims (31)

1. A method for reducing the risk of cardiovascular death in a patient with chronic kidney disease, the method comprising administering a pharmaceutically effective amount of empagliflozin to the patient.

2. A method for treating, reducing the risk of or slowing the progression of chronic kidney disease and reducing the risk of cardiovascular death in a patient with chronic kidney disease, the method comprising administering a pharmaceutically effective amount of empagliflozin to the patient.

3. The method according to claim 1 , wherein the cardiovascular death is due to fatal myocardial infarction or fatal stroke.

4. The method according to claim 1 , wherein the cardiovascular death is due to sudden death or heart failure death.

5. The method of claim 1 , wherein the patient has moderately to severely decreased renal function.

6. The method of claim 1 , wherein the patient has elevated albuminuria levels ≥200 mg/g.

7. The method of claim 1 , wherein the patient has an estimated glomerular filtration rate (eGFR)≥20 to <45 mL/min/1.73 m2.

8. The method of claim 1 , wherein the patient has an estimated glomerular filtration rate (eGFR)≥20 mL/min/1.73 m2 and a urinary albumin-to-creatinine ratio (UACR) ≥200 mg/g.

9. The method of claim 1 , wherein the patient has an eGFR≥45 and <90 ml/min/1.73m2 and a urinary albumin-to-creatinine ratio (UACR)≥200 mg/g.

10. The method of claim 1 , wherein the patient is treated with a renin-angiotensin-aldosterone system (RAAS) inhibitor.

11. The method of claim 1 , wherein the patient is treated with an Angiotensin-Converting Enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB).

12. The method of claim 1 , wherein the patient is a non-diabetic patient.

13. The method of claim 1 , wherein the patient is a non-diabetic and non-prediabetic patient.

14. The method of claim 1 , wherein the patient is a patient with pre-diabetes or a patient with type 2 or type 1 diabetes mellitus.

15. The method of claim 1 , wherein empagliflozin is administered at a dose in a range from 1 mg to 25 mg.

16. The method of claim 1 , wherein empagliflozin is administered at a dose of

10 mg or 25 mg.

17. The method of claim 1 , wherein empagliflozin is administered once daily to the patient.

18. The method of claim 2 , wherein the patient has moderately to severely decreased renal function.

19. The method of claim 2 , wherein the patient has elevated albuminuria levels ≥200 mg/g.

20. The method of claim 2 , wherein the patient has an estimated glomerular filtration rate (eGFR)≥20 to <45 mL/min/1.73 m2.

21. The method of claim 2 , wherein the patient has an estimated glomerular filtration rate (eGFR)≥20 mL/min/1.73 m2 and a urinary albumin-to-creatinine ratio (UACR)≥200 mg/g.

22. The method of claim 2 , wherein the patient has an estimated glomerular filtration rate (eGFR)≥45 and <90 ml/min/1.73m2 and a urinary albumin-to-creatinine ratio (UACR)≥200 mg/g.

23. The method of claim 2 , wherein the patient is treated with a renin-angiotensin-aldosterone system (RAAS) inhibitor.

24. The method of claim 2 , wherein the patient is treated with an Angiotensin-Converting Enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB).

25. The method of claim 2 , wherein the patient is a non-diabetic patient.

26. The method of claim 2 , wherein the patient is a non-diabetic and non-prediabetic patient.

27. The method of claim 2 , wherein the patient is a patient with pre-diabetes or a patient with type 2 or type 1 diabetes mellitus.

28. The method of claim 2 , wherein empagliflozin is administered at a dose in a range from 1 mg to 25 mg.

29. The method of claim 2 , wherein empagliflozin is administered at a dose of 10 mg or 25 mg.

30. The method of claim 2 , wherein empagliflozin is administered once daily to the patient.

Continuity (6)
Continuation 17094045 · Nov 10, 2020
Continuation 16738116 · Jan 9, 2020
Continuation 15806389 · Nov 8, 2017
Provisional Application 62514249 · Jun 2, 2017
Provisional Application 62420062 · Nov 10, 2016
Related Publication 20220288012A1 · Sep 15, 2022
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