PHARMACEUTICAL COMPOSITION, METHODS FOR TREATING AND USES THEREOF

1 . A method for preventing, protecting against or delaying loss of eGFR and/or for delaying the progression to end stage renal disease/kidney failure, or renal death 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.

2 . The method according to claim 1 for delaying loss of eGFR and/or for delaying the progression to end stage renal disease 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.

3 . The method according to claim 1 , wherein the patient with chronic kidney disease is a patient with albuminuria.

4 . The method according to claim 3 , wherein the patient with chronic kidney disease is a patient with microalbuminuria or with macroalbuminuria.

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

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

7 . 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.

8 . The method according to claim 1 , wherein the patient is a patient with stage 1 chronic kidney disease, stage 2 chronic kidney disease, stage 3 chronic kidney disease, stage 4 chronic kidney disease, or stage 5 chronic kidney disease.

9 . The method according to claim 8 , wherein the patient is a patient with stage 2 chronic kidney disease, stage 3 chronic kidney disease or stage 4 chronic kidney disease.

10 . 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 >1=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.

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

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

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

14 . 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).

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

16 . 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).

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

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