METHOD OF TREATING CARDIOVASCULAR EVENTS USING COLCHICINE CONCURRENTLY WITH AN ANTITHROMBOTIC DRUG

• US 20150196514A1
• Filed: 01/22/2015
• Published: 07/16/2015
• Est. Priority Date: 11/02/2012
• Status: Abandoned Application

• Current Assignee: Murray & Poole Enterprises, Ltd.
• Original Assignee: Murray & Poole Enterprises, Ltd.
• Inventors: Nidorf, Mark
• Application Number:
  US14/603,085
• Publication Number:
  US 20150196514A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 antithrombotic drug, thereby treating and/or preventing the cardiovascular event in the patient are provided.

Claims

1. A method of treating and/or preventing a cardiovascular event in a patient, the method comprising administering a composition comprising an effective amount of colchicine to a patient who is receiving concurrent treatment with at least one antithrombotic drug, thereby treating and/or preventing the cardiovascular event in the patient.

2. The method of claim 1, wherein the patient has atherosclerotic vascular disease.

3. The method of claim 2, wherein the atherosclerotic vascular disease is a coronary disease.

4. The method of claim 3, wherein the coronary disease is a clinically stable coronary disease.

5. The method of claim 1, wherein the cardiovascular event is acute coronary syndrome, out-of-hospital cardiac arrest or noncardioembolic ischemic stroke.

6. The method of claim 1, wherein the antithrombotic drug is selected from the group consisting of an antiplatelet agent, an anticoagulant agent, a thrombolytic agent, and combinations thereof.

7. The method of claim 6, wherein the antithrombotic drug is an antiplatelet agent.

8. The method of claim 7, wherein the antiplatelet agent is selected from the group consisting 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, a thromboxane inhibitor and combinations thereof.

9. The method of claim 8, wherein the irreversible cyclooxygenase inhibitor is selected from the group consisting of aspirin, triflusal and combinations thereof.

10. The method of claim 7, wherein the ADP receptor inhibitor is selected from the group consisting of clopidogrel, prasugrel, ticagrelor, ticlopidine and combinations thereof.

11. The method of claim 7, wherein the phosphodiesterase inhibitor is cilostazol.

12. The method of claim 7, wherein the PAR-1 antagonist is vorapaxar.

13. The method of claim 7, wherein the glycoprotein IIB/IIIA inhibitor is selected from the group consisting of abciximab, eptifibatide, tirofiban and combinations thereof.

14. The method of claim 7, wherein the adenosine reuptake inhibitor is dipyridamole.

15. The method of claim 7, wherein the thromboxane inhibitor is selected from the group consisting of thromboxane synthase inhibitors, thromboxane receptor antagonists and combinations thereof.

16. The method of claim 15, wherein the thromboxane synthase inhibitor is terutroban.

17. The method of claim 6, wherein the antithrombotic drug is an anticoagulant agent.

18. The method of claim 17, wherein the anticoagulant agent is selected from the group consisting of novel oral anticoagulants (NOACs), coumarins (vitamin K antagonists), heparin and derivatives, low molecular weight heparin, synthetic pentasaccharide inhibitors of factor Xa, direct factor Xa inhibitors, direct thrombin inhibitors, antithrombin protein therapeutics and combinations thereof.

19. The method of claim 18, wherein the noval oral anticoagulant is selected from the group consisting of dabigatran, rivaroxaban, apixaban and combinations thereof.

20. The method of claim 18, wherein the coumarin (vitamin K antagonist) is selected from the group consisting of warfarin, acenocoumarol, phenprocoumon, atromentin, brodifacoum, phenindione and combinations thereof.

21. The method of claim 18, wherein the low molecular weight heparin is selected from the group consisting of dalteparin, enoxaparin and combinations thereof.

22. The method of claim 18, wherein the direct factor Xa inhibitor is selected from the group consisting of rivaroxaban, apixaban, edoxaban, darexaban and combinations thereof.

23. The method of claim 18, wherein the direct thrombin inhibitor is selected from the group consisting of hirudin, lepirudin, bivalirudin, ximelagatrain and combinations thereof.

24. The method of claim 6, wherein the antithrombotic drug is a thrombolytic agent.

25. The method of claim 24, wherein the thrombolytic agent is tissue plasminogen activator (t-PA).

26. The method of claim 25, wherein the t-PA is selected from the group consisting of alteplase, reteplase, tenecteplase, anistreplase, streptokinase, urokinase and combinations thereof.

27. The method of claim 1, wherein colchicine is included in an amount of no more than 0.60 mg.

28. The method of claim 1, wherein colchicine is included in an amount equal to or about 0.50 mg.

29. The method of claim 1, wherein the incidence of the patient having a cardiovascular event is reduced by at least 50% when at least one antithrombotic drug is administered concurrently with colchicine as compared to when at least one antithrombotic drug is administered in the absence of colchicine.

30. The method of claim 1, wherein the colchicine and at least one antithrombotic agent are administered as one dosage form.

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

32. The method of claim 1, wherein the composition of colchicine is administered as a sustained release formulation.