Prophylactic and therapeutic drug for nonalcoholic fatty liver disease

Abstract

The present invention addresses the problem of providing a medicinal composition and a drug combination by which nonalcoholic fatty liver disease and nonalcoholic steatohepatitis can be prevented and/or treated. The present invention provides a combination of a peroxisome proliferator-activated receptor (PPAR) α agonist with a sodium glucose cotransporter 2 (SGLT2) inhibitor, which is to be used for preventing and/or treating nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.

1 . A prophylactic and/or therapeutic agent for liver disease, comprising a combination of a PPARα agonist with an SGLT2 inhibitor. 
     
     
         2 . The prophylactic and/or therapeutic agent according to  claim 1 , wherein the liver disease comprises nonalcoholic fatty liver disease. 
     
     
         3 . The prophylactic and/or therapeutic agent according to  claim 2 , wherein the nonalcoholic fatty liver disease comprises nonalcoholic steatohepatitis. 
     
     
         4 . The prophylactic and/or therapeutic agent according to  claim 2 , having an effect to suppress hepatocyte ballooning in a subject with nonalcoholic fatty liver disease. 
     
     
         5 . The prophylactic and/or therapeutic agent according to  claim 1 , wherein the liver disease comprises liver cirrhosis or hepatocellular carcinoma. 
     
     
         6 . The prophylactic and/or therapeutic agent according to  claim 1 , wherein the PPARα agonist is (R)-2-[3-[[N-(benzoxazol-2-yl)-N-3-(4-methoxyphenoxy)propyl]aminomethyl]phenoxy]butyric acid or a salt thereof, or a solvate thereof. 
     
     
         7 . The prophylactic and/or therapeutic agent according to  claim 1 , wherein the SGLT2 inhibitor is selected from the group consisting of dapagliflozin, canagliflozin, ipragliflozin, empagliflozin, luseogliflozin, tofogliflozin, ertugliflozin, sotagliflozin, bexagliflozin and remogliflozin. 
     
     
         8 . The prophylactic and/or therapeutic agent according to  claim 1 , being a combination drug. 
     
     
         9 . The prophylactic and/or therapeutic agent according to  claim 1 , being a kit. 
     
     
         10 . A kit comprising a prophylactic and/or therapeutic agent of  claim 1 . 
     
     
         11 . A method for treating a subject suffering from or susceptible to a liver disease, the method comprising:
 administering to the subject a PPARα agonist and an SGLT2 inhibitor.   
     
     
         12 . The method of  claim 11  the subject is suffering from nonalcoholic fatty liver disease. 
     
     
         13 . The method of  claim 11  wherein the subject is suffering from nonalcoholic steatohepatitis. 
     
     
         14 . The method of  claim 11  wherein the subject is suffering from liver cirrhosis. 
     
     
         15 . The method of  claim 11  wherein the subject is suffering from hepatocellular carcinoma. 
     
     
         16 . The method of  claim 11  wherein the subject is identified as suffering from liver disease and an effective amount of a PPARα agonist and an SGLT2 inhibitor is administered to the identified subject.