Pharmaceutical composition, methods for treating and uses thereof

Abstract

The present invention relates to certain SGLT-2 inhibitors for treating, preventing, protecting against and/or delaying the progression of chronic kidney disease in patients, for example patients with prediabetes, type 1 or type 2 diabetes mellitus.

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.