Claims for Patent: 10,265,281

Summary for Patent: 10,265,281

Title:	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative
Abstract:	A method for the treatment or prevention of a cardiovascular event in a subject with atherosclerotic vascular disease comprising the step of:
Inventor(s):	Mark Nidorf
Assignee:	Murray and Poole Enterprises Ltd
Application Number:	US14/440,147
Patent Claims:	1. A method for treating and/or reducing the risk of a cardiovascular event in a subject in need thereof comprising: administering to the subject a therapeutically effective amount of a composition comprising no more than about 0.6 total mg of (i) colchicine, (ii) a salt of (i), or any combination of (i)-(ii), wherein the composition is administered once per day, thereby treating and/or reducing the risk of the cardiovascular event in the subject. 2. The method of claim 1, wherein the composition is administered orally, topically, parenterally, intraorbitally, ophthalmically, intraventricularly, intracranially, intracapsularly, intraspinally, intracisternally, intraperitoneally, buccally, rectally, vaginally, intranasally, by aerosol administration and/or inhalation spray, or by an implanted reservoir. 3. The method of claim 1, wherein the composition is administered in the form of a tablet, capsule, liquid dose, gel or powder. 4. The method of claim 1, wherein the composition comprises about 0.5 mg of (i) colchicine, (ii) the salt of (i), or any combination of (i)-(ii). 5. The method of claim 1, wherein the subject has atherosclerotic vascular disease. 6. The method of claim 5, wherein the atherosclerotic vascular disease is a coronary disease. 7. The method of claim 6, wherein the coronary disease is a clinically stable coronary disease. 8. The method of claim 1, wherein the cardiovascular event is acute coronary syndrome, out-of-hospital cardiac arrest or noncardioembolic ischemic stroke. 9. The method of claim 1, further comprising co-administering to the subject a therapeutically effective amount of a second agent for the treatment and/or reduction of risk of the cardiovascular event in the subject. 10. The method of claim 9, wherein the second agent is a colchicine-compatible statin. 11. The method of claim 10, wherein the colchicine-compatible statin is selected from the group consisting of: (i) atorvastatin, (ii) fluvastatin, (iii) lovastatin, (iv) pitavastatin, (v) rosuvastatin, (vi) simvastatin, (vii), pravastatin, a salt of any of (i)-(vii), or any combination thereof. 12. The method of claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier, diluent or excipient. 13. The method of claim 1, wherein the composition reduces the risk of the subject having a cardiovascular event by a greater percentage than a composition that does not include (i)-(ii). 14. The method of claim 13, wherein the risk of out-of-hospital cardiac arrest is reduced by at least about 10%, at least about 20%, at least about 30%, at least about 40%, or at least about 50%. 15. The method of claim 13, wherein the risk of acute coronary syndrome is reduced by at least about 10%, at least about 20%, at least about 30%, at least about 40%, or at least about 50%. 16. The method of claim 13, wherein the risk of noncardioembolic ischemic stroke is reduced by at least about 10%, at least about 20%, at least about 30%, at least about 40%, or at least about 50%. 17. The method of claim 1, wherein administration of the compound also reduces the risk of an adverse gastrointestinal event in the subject. 18. The method of claim 17, wherein the composition reduces the risk of an adverse gastrointestinal event in the subject as compared to administration of a composition that includes more than 1.0 total mg of (i) colchicine, (ii) a salt of (i), or any combination of (i)-(ii). 19. A method for treating and/or reducing the risk of a cardiovascular event in a subject in need thereof, that comprises: administering to the subject a therapeutically effective amount of a composition comprising no more than about 0.6 total mg of (i) colchicine, (ii) a salt of (i), or any combination of (i)-(ii), wherein the composition is administered once per day, wherein the composition is in the form of a tablet, wherein the cardiovascular event is acute coronary syndrome, out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke, and wherein the composition is homogeneous. 20. The method of claim 19, wherein the composition comprises about 0.5 mg of (i) colchicine, (ii) the salt of (i), or any combination of (i)-(ii). 21. The method of claim 19, wherein the subject has atherosclerotic vascular disease. 22. The method of claim 21, wherein the atherosclerotic vascular disease is a coronary disease. 23. The method of claim 22, wherein the coronary disease is a clinically stable coronary disease. 24. The method of claim 19, further comprising co-administering to the subject a therapeutically effective amount of a second agent for the treatment and/or reduction of risk of the cardiovascular event in the subject.