Methods of reducing risk of cardiovascular disease
Methods of lowering the plasma LDL-C levels in a patient on a stable dose of statin where the patient has an LDL-C level above treatment goal. Methods of decreasing a patient's risk for developing coronary heart disease or having a recurrent cardiovascular event wherein the patient is on a stable dose of statin and the patient has an LDL-C level above treatment goal.
1. A method of treating a patient on a stable dose of statin comprising administering to the patient the compound:
or a salt, or a hydrate thereof, wherein the patient on a stable dose of statin requires additional lowering of LDL-C; wherein the daily dose of the compound administered is from about 100 mg to about 900 mg; and wherein following treatment, the patient's LDL-C level is reduced.
2. The method of claim 1 , wherein the patient's LDL-C level is reduced from baseline by at least 20%.
3. The method of claim 2 , wherein the patient's LDL-C level is reduced from baseline by at least 30%.
4. The method of claim 1 , wherein the daily dose is administered once daily.
5. The method of claim 4 , wherein the daily dose is from about 300 mg to about 900 mg.
6. The method of claim 5 , wherein the daily dose is 300 mg, 600 mg or 900 mg.
7. The method of claim 1 , wherein the stable dose of statin is from about 1 mg to about 80 mg administered daily.
8. The method of claim 7 , wherein the statin is atorvastatin, lovastatin, simvastatin, pravastatin, rosuvastatin, fluvastatin, or pitavastatin.
9. The method according to claim 8 , wherein the statin is atorvastatin and the stable dose of statin is from about 10 mg to about 80 mg.
10. The method according to claim 8 , wherein the statin is rosuvastatin and the stable dose of statin is from about 2.5 to about 40.
11. The method according to claim 8 , wherein the statin is simvastatin and the stable dose of statin is from about 10 mg to about 80 mg.
12. The method according to claim 4 , wherein the patient is administered one or more additional cholesterol lowering drug independently selected from the group consisting of: a cholesterol absorption inhibitor, a bile acid sequestrant, a cholesteryl ester transfer protein inhibitor, a microsomal triglyceride transfer protein inhibitor, a PCSK9 inhibitor, a microRNA-33 inhibitor, a squalene synthase inhibitor and an apoB synthesis inhibitor.
13. The method according to claim 1 , wherein the patient has a baseline LDL-C level ≥70 mg/dL.
14. The method according to claims 13 , wherein the patient has a baseline LDL-C level level ≥100 mg/dL.
15. The method according to claim 1 , wherein the patient's LDL-C level is reduced from baseline by at least 15%.
16. A method of treating a patient on a maximally tolerated dose of a statin comprising administering to the patient the compound:
or a salt, or a hydrate thereof, wherein the patient on a maximally tolerated dose of a statin requires additional lowering of LDL-C; wherein the daily dose of the compound administered is from about 100 mg to about 900 mg; and wherein following treatment the patient's LDL-C level is reduced.
17. The method according to claim 16 , wherein the patient's LDL-C level is reduced from baseline by at least 15%.
18. The method of claim 16 , wherein the patient's LDL-C level is reduced from baseline by at least 20%.
19. The method of claim 16 , wherein the patient's LDL-C level is reduced from baseline by at least 30%.
20. The method of claim 16 , wherein the daily dose is administered once daily.
21. The method of claim 20 , wherein the daily dose is from about 300 mg to about 900 mg.
22. The method of claim 21 , wherein the daily dose is 300 mg, 600 mg or 900 mg.
23. The method of claim 16 , wherein the stable dose of statin is from about 1 mg to about 80 mg administered daily.
24. The method of claim 23 , wherein the statin is atorvastatin, lovastatin, simvastatin, pravastatin, rosuvastatin, fluvastatin, or pitavastatin.
25. The method according to claim 16 , wherein the statin is atorvastatin and the stable dose of statin is from about 10 mg to about 80 mg.
26. The method according to claim 16 , wherein the patient has a baseline LDL-C level ≥70 mg/dL.
27. The method according to claims 16 , wherein the patient has a baseline LDL-C level >100 mg/dL.