PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF

1 ) A method of treating, preventing, protecting against, reducing the risk of, delaying the occurrence of and/or delaying the progression of chronic kidney disease in a patient, said method comprising administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient.

2 ) The method according to claim 1 , wherein the progression of said chronic kidney disease is the progression to end stage renal disease/kidney failure, or renal death in the patient.

3 ) The method according to claim 1 , wherein said patient is at risk for renal disease.

4 ) The method according to claim 1 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

5 ) The method according to claim 1 , wherein the patient has or is at risk of a cardiovascular disease.

6 ) The method according to claim 1 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus and with or at risk of a cardiovascular disease.

7 ) A method of treating, preventing, protecting against or delaying new onset of albuminuria in a patient, said method comprising administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient.

8 ) The method according to claim 7 , wherein said patient is at risk for renal disease.

9 ) The method according to claim 7 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

10 ) The method according to claim 7 , wherein the patient has or is at risk of a cardiovascular disease.

11 ) The method according to claim 7 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus and with or at risk of a cardiovascular disease.

12 ) A method of treating, preventing, protecting against or delaying the progression from no albuminuria to micro- or macroalbuminuria in a patient at risk for renal disease, said method comprising administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient.

13 ) The method according to claim 12 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

14 ) A method of treating, preventing, protecting against or delaying the progression from microalbuminuria to macroalbuminuria in a patient with chronic kidney disease, said method comprising administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient.

15 ) The method according to claim 14 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

16 ) A method for treating, preventing, protecting against or delaying the progression of chronic kidney disease in a patient, said method administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient.

17 ) The method according to claim 16 , comprising preventing, protecting against or delaying loss of eGFR, for example sustained eGFR loss of ≧50%, in said patient.

18 ) The method according to claim 16 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

19 ) A method of treating, preventing, protecting against or delaying the occurrence of:

new onset of albuminuria,

doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≦45 mL/min/1.73 m 2 ,

need for continuous renal replacement therapy, or

death due to renal disease,

in a patient, said method comprising administering empagliflozin, optionally in combination with one or more other therapeutic substances, to the patient.

20 ) The method according to claim 19 , wherein the patient has chronic kidney disease.

21 ) The method according to claim 19 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

22 ) The method according to claim 19 , wherein the patient has or is at risk of a cardiovascular disease.

23 ) The method according to claim 19 , wherein the patient is a patient with prediabetes, type 1 or type 2 diabetes and with or at risk of a cardiovascular disease.

24 ) The method according to claim 19 , wherein the patient has chronic kidney disease and is a patient with prediabetes, type 1 or type 2 diabetes mellitus.

25 ) The method according to claim 1 , wherein the patient is a patient with one or more cardiovascular risk factors selected from A), B), C) and D):

A) previous or existing vascular disease selected from myocardial infarction, coronary artery disease, percutaneous coronary intervention, coronary artery by-pass grafting, ischemic or hemorrhagic stroke, congestive heart failure, and peripheral occlusive arterial disease,

B) advanced age>/=60-70 years, and

C) one or more cardiovascular risk factors selected from

advanced type 1 or type 2 diabetes mellitus >10 years duration,

hypertension,

current daily cigarette smoking,

dyslipidemia,

obesity,

age>/=40,

metabolic syndrome, hyperinsulinemia or insulin resistance, and

hyperuricemia, erectile dysfunction, polycystic ovary syndrome, sleep apnea, or family history of vascular disease or cardiomyopathy in first-degree relative;

D) one or more of the following:

confirmed history of myocardial infarction,

unstable angina with documented multivessel coronary disease or positive stress test,

multivessel Percutaneous Coronary Intervention,

multivessel Coronary Artery By-pass Grafting (CABG),

history of ischemic or hemorrhagic stroke,

peripheral occlusive arterial disease.

26 ) The method according to claim 1 , wherein the one or more other therapeutic substances are selected from other antidiabetic substances.

27 ) The method according to claim 1 , comprising administering empagliflozin in combination with metformin, with linagliptin or with metformin and linagliptin.

28 ) The method according to claim 1 , wherein the one or more other therapeutic substances is a RAAS inhibitor.

29 ) The method according to claim 1 , wherein the one or more other therapeutic substances is a direct renin inhibitor, an Angiotensin-Converting Enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB).

30 ) The method according to claim 1 , comprising administering empagliflozin in combination with a RAAS inhibitor.

31 ) The method according to claim 1 , comprising administering empagliflozin in combination with a direct renin inhibitor, an Angiotensin-Converting Enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB).

32 ) The method according to claim 1 , wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg.

33 ) The method according to claim 1 , wherein empagliflozin is administered as a pharmaceutical composition comprising 10 mg or 25 mg of empagliflozin.