Anti-proliferative and anti-inflammatory agent combination for treatment of vascular disorders

• US 20060105019A1
• Filed: 12/29/2005
• Published: 05/18/2006
• Est. Priority Date: 12/16/2002
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Consigny, Paul, Zhang, Gina, Stewart, Gordon, Park, Gene, Feezor, Christopher, Roorda, Wouter, Dugan, Stephen, Kirsten, Nancy, Hossainy, Sayed Faiyaz Ahmed
• Granted Patent: US 8,586,069 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/4745 condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Drug-delivery systems such as drug-delivery stents having an anti-proliferative agent such as everolimus and an anti-flammatory agent such as clobetasol are provided. Also disclosed are methods of treating a vascular impairment such as restenosis or vulnerable plaque.

Claims

1. A drug-delivery system, comprising an effective amount of everolimus, or derivatives thereof, and an effective amount of clobetasol for the treatment or prevention of a vascular disorder or a related disorder.

2. The drug-delivery system of claim 1, wherein the system is a stent.

3. The drug-delivery system of claim 1, wherein the disorder is restenosis.

4. The drug-delivery system of claim 1, wherein the disorder is restenosis and/or progression of atherosclerosis in patient subsets including type I diabetics and type II diabetics.

5. The drug-delivery system of claim 1, wherein the disorder is vulnerable plaque.

6. The drug-delivery system of claim 1, wherein the system is a polymer or a polymeric coating.

7. A drug-delivery system, comprising

an effective amount of everolimus, rapamycin, or derivatives of everolimus or rapamycin, and

an effective amount of a steroidal anti-inflammatory agent or a non steroidal anti-inflammatory agent, wherein the combination is for treatment or prevention of a vascular disorder.

8. The drug-delivery system of claim 7, wherein the anti-inflammatory agent is clobetasol.

9. The drug-delivery system of claim 7, wherein the system is a stent.

10. The drug-delivery system of claim 7, wherein the disorder is restenosis.

11. The drug-delivery system of claim 7, wherein the disorder is restenosis and/or progression of atherosclerosis in patient subsets including type I diabetics and type II diabetics.

12. The drug-delivery system of claim 7, wherein the disorder is vulnerable plaque.

13. The drug-delivery system of claim 7, wherein the system is a polymer or a polymeric coating.

14. A method of treating restenosis of a blood vessel comprising administering to a patient an effective amount of everolimus, rapamycin, or derivatives of everolimus or rapamycin and an effective amount of a steroidal anti-inflammatory agent or a non steroidal anti-inflammatory agent, wherein the combination is for treatment or prevention of the vascular disorder.

15. The method of claim 14, wherein the anti-inflammatory is clobetasol.

16. The method of claim 14, wherein everolimus, rapamycin, or derivatives of everolimus or rapamycin is delivered via a stent and the anti-inflammatory is delivered by other local means or by systemic means.

17. The method of claim 14, wherein the combination of the drugs are administered by a drug-delivery stent.

18. A method of treating vulnerable plaque of a blood vessel comprising

administering to a patient an effective amount of everolimus, rapamycin, or derivatives of everolimus or rapamycin and an effective amount of a steroidal anti-inflammatory agent or a non steroidal anti-inflammatory agent, wherein the combination is for treatment or prevention of the vascular disorder.

19. The method of claim 18, wherein the anti-inflammatory is clobetasol.

20. The method of claim 18, wherein everolimus, rapamycin, or derivatives of everolimus or rapamycin is delivered via a stent and the anti-inflammatory is delivered by local means other than a stent or by systemic means.

21. The method of claim 18, wherein the combination of the drugs are administered by a drug-delivery stent.