Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Disclosed herein are compositions comprising fixed doses of ETC-1002 and Ezetimibe. Also disclosed herein are methods for using fixed doses of ETC-1002 and Ezetimibe. Uses include methods of treating cardiovascular disease or reducing the risk of cardiovascular disease in a subject. Uses also include methods of treating hypercholesterolemia in a subject.
1. A method of treating familial hypercholesterolemia in a subject in need thereof, the method comprising administering a fixed-dosed combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe to the subject, wherein the fixed-dose combination comprises a fixed 180 milligram (mg) dose of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and a fixed 10 milligram (mg) dose of Ezetimibe.
2. The method of claim 1 , wherein administering the fixed-dose combination decreases the level of LDL-C in the subject below that of a control subject receiving a placebo.
3. The method of claim 1 , wherein administering the fixed-dose combination decreases the level of C-reactive protein (hsCRP) in the subject.
4. The method of claim 1 , wherein administering the fixed-dose combination decreases the number of very low density lipoprotein in the subject.
5. The method of claim 1 , wherein administering the fixed-dose combination reduces the risks of cardiovascular diseases in the subject.
6. The method of claim 1 , wherein administering the fixed-dose combination decreases the level of LDL-C in the subject by at least 30% relative to baseline.
7. The method of claim 1 , wherein administering the fixed-dose combination decreases the level of hsCRP in the subject by at least 26% relative to baseline.
8. The method of claim 1 , wherein administering the fixed-dose combination decreases the level of hsCRP in the subject by at least 30% relative to baseline.
9. The method of claim 1 , wherein the fixed-dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is administered once daily to the subject.
10. The method of claim 1 , wherein the fixed dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is formulated to be a tablet.
11. The method of claim 1 , wherein the fixed dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is formulated for oral delivery.
12. The method of claim 1 , wherein the fixed dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is formulated for administration once daily.
13. The method of claim 1 , wherein the subject is human.