Combination comprising an omega-3 fatty acid composition and an SGLT2 inhibitor
A method for treating NAFLD and/or NASH and suitable compositions for carrying out the method are claimed.
1. A combination of an effective dose of an omega-3 fatty acid composition, and an effective dose of dapagliflozin or a pharmaceutically acceptable salt thereof, for the treatment of non-alcoholic steatohepatitis (NASH) in a subject having, or suspected of having, NASH;
wherein the omega-3 fatty acid composition comprises:
about 50-60 wt % eicosapentaenoic acid (EPA);
about 15-25 wt % docosahexaenoic acid (DHA);
about 1 to 8 wt % docosapentaenoic acid (DPA);
wherein at least 90 wt % of the polyunsaturated fatty acid in the composition is present in free acid form.
2. A method of treating NASH comprising:
selecting a subject having, or suspected of having NASH on the basis of their non-alcoholic fatty liver disease (NAFLDU) Activity Score;
administering the combination of claim 1 ; and
thereby improving the NAFLD Activity Score of said subject by at least 1 point, with no worsening of the subject's fibrosis stage score.
3. The method of claim 2 , wherein the subject's NAFLD Activity Score is greater than or equal to 5.
4. The combination of claim 1 wherein the subject has been diagnosed with Type II diabetes mellitus.
5. A combination of an effective dose of an omega-3 fatty acid composition and an effective dose of dapagliflozin or a pharmaceutically acceptable salt thereof, for the reduction of liver fat in a subject who has been diagnosed with Type II diabetes mellitus and diagnosed as having raised liver fat;
wherein the omega-3 fatty acid composition comprises:
about 50-60 wt % EPA;
about 15-25 wt % DHA;
about 1 to 8 wt % DPA;
wherein at least 90 wt % of the polyunsaturated fatty acid in the composition is present in free acid form.
6. The combination of claim 5 , wherein the combination also causes a reduction in plasma triglyceride level in the subject.
7. The combination of claim 5 , wherein the combination also causes a raising of plasma EPA and/or DHA levels in the subject.
8. The combination of claim 5 , wherein the combination also causes a reduction of cell death and/or ballooning in the subject.
9. The combination of claim 5 , wherein the subject has a Body Mass Index (BMI)>25.
10. A combination comprising an omega-3 fatty acid composition and dapagliflozin or a pharmaceutically acceptable salt thereof;
wherein the omega-3 fatty acid composition comprises:
about 50-60 wt % EPA;
about 15-25 wt % DHA;
about 1 to 8 wt % DPA:
wherein at least 90 wt % of the polyunsaturated fatty acid in the composition is present in free acid form.
11. The combination of claim 10 , wherein the omega-3 fatty acid composition is present in an amount of 1 g, 2 g or 4 g.
12. The combination of claim 10 , wherein dapagliflozin or a pharmaceutically salt thereof is present in an amount of 5 or 10 mg.
13. A method for the reduction of liver fat and the reduction of liver inflammation in a subject in need thereof, comprising administering the combination of claim 10 to the subject.
14. A method for halting progression of liver fibrosis in a subject in need thereof, comprising administering the combination of claim 10 to the subject.
15. A method for halting progression of NAFLD and/or NASH thereby causing a halt in progression of fibrosis of the subject's liver in a subject who has been diagnosed with NAFLD or NASH, comprising administering the combination of claim 10 to the subject.
16. A method for the treatment of NASH, in a subject having, or suspected of having NASH, comprising administering the combination of claim 10 , and thereby causing a reduction in body weight of the subject.
17. A method for wherein the treatment of NASH, in a subject having, or suspected of having NASH, comprising administering the combination of claim 10 , and thereby causing an increase in insulin sensitisation of the subject.