Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent

• US 10,842,762 B2
• Filed: 08/26/2019
• Issued: 11/24/2020
• Est. Priority Date: 11/02/2012
• Status: Active Grant

• Current Assignee: Murray & Poole Enterprises, Ltd.
• Original Assignee: Murray & Poole Enterprises, Ltd.
• Inventors: Nidorf, Mark
• Primary Examiner(s): Reese, Heidi
• Application Number:
  US16/550,692
• Publication Number:
  US 20190374487A1
• Time in Patent Office: 456 Days
• Field of Search: None
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen
• CPC Class Codes: A61K 31/4365 the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
• CPC Class Codes: A61K 31/616 by carboxylic acids, e.g. acetylsalicylic acid
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Methods of treating and/or preventing a cardiovascular event in a patient, the method comprising orally administering a colchicine to a patient who is receiving concurrent treatment with at least one antiplatelet agent, thereby treating and/or preventing the cardiovascular event in the patient are provided.

Claims

1. A method of treating and/or reducing the risk of inflammation in a subject, the method comprising:

administering a composition comprising about 0.5 to about 0.7 mg of colchicine, a salt thereof, and/or any combination thereof to a subject in need thereof, wherein the composition is administered once per day.

2. The method of claim 1, wherein inflammation is inflammation of any part of the heart or blood vessel.

3. The method of claim 1, wherein the subject has, or has been diagnosed with, atherosclerotic vascular disease.

4. The method of claim 3, wherein the atherosclerotic vascular disease is coronary disease.

5. The method of claim 1, wherein inflammation is cholesterol crystal induced inflammation within atherosclerotic plaques.

6. The method of claim 1, wherein about 0.6 mg of the composition is administered to the subject.

7. The method of claim 1, wherein the composition is administered orally, topically, parenterally, ophthalmically, intraventricularly, intraperitoneally, buccally, rectally, vaginally, intranasally, or by aerosol administration and/or inhalation spray.

8. The method of claim 1, wherein the composition is administered in the form of a tablet, capsule, liquid dose, gel, or powder.

9. The method of claim 1, wherein the subject receives concurrent treatment with at least one anticoagulant agent or antiplatelet agent.

10. The method of claim 9, wherein the antiplatelet agent and/or the anticoagulant agent is aspirin.

11. The method of claim 9, wherein the antiplatelet agent is one or more of an irreversible cyclooxygenase inhibitor, an adenosine diphosphate (ADP) receptor inhibitor, a phosphodiesterase inhibitor, a protease-activated receptor-1 (PAR-1) antagonist, a glycoprotein IIB/IIIA inhibitor, an adenosine reuptake inhibitor, and a thromboxane inhibitor.

12. 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.

13. The method of claim 12, wherein the second agent is a statin.

14. The method of claim 13, wherein the statin is atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin, any salt thereof, or any combination thereof.

15. The method of claim 1, wherein the composition is administered in the form of a tablet, capsule, liquid, powder, or gel.

16. The method of claim 4, wherein the subject is concurrently administered an agent for the treatment and/or reduction of the risk of an atherosclerotic vascular disease.

17. The method of claim 16, wherein the agent is a statin.

18. The method of claim 17, wherein the statin is atorvastatin, fluvastatin, lovastatin, pitavastatin, rosuvastatin, simvastatin, pravastatin, a salt thereof, or any combination thereof.

19. The method of claim 1, wherein the composition of colchicine is administered as an immediate release formulation.

20. The method of claim 1, wherein the composition is administered approximately daily over a period of at least two years.

21. A method of treating and/or reducing the risk of atherosclerotic vascular disease in a subject in need thereof, which comprises administering to the subject a composition comprising about 0.5 to about 0.7 total mg of colchicine, a salt thereof, and/or any combination thereof, wherein the composition is administered once per day to the subject.

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 21, wherein the composition reduces or prevents cholesterol crystal induced inflammation within atherosclerotic plaques.

25. The method of claim 21, wherein the composition is formulated in a daily dosage for administration once per day.

26. The method of claim 21, wherein the composition is formulated for administration orally, topically, parenterally, intraorbitally, ophthalmically, intraventricularly, intracranially, intracapsularly, intraspinally, intracisternally, intraperitoneally, buccally, rectally, vaginally, intranasally, or by aerosol administration, and/or inhalation spray, or via an implanted reservoir.

27. The method of claim 21, wherein the composition is in the form of a tablet, capsule, liquid dose, gel, or powder.

28. The method of claim 21, wherein the tablet is an immediate release tablet.

29. The method of claim 21, wherein the composition comprises about 0.6 mg of colchicine, a salt thereof, or any combination thereof.

30. A method for treating and/or reducing the risk of cholesterol crystal induced inflammation within atherosclerotic plaques in a subject who has been diagnosed with atherosclerotic vascular disease, which comprises administering 0.5 mg to 0.6 mg of colchicine, a pharmaceutically acceptable salt of colchicine, or any combination thereof, wherein the colchicine is administered once per day.