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

• US 8,586,069 B2
• Filed: 12/29/2005
• Issued: 11/19/2013
• Est. Priority Date: 12/16/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Stewart, Gordon, Zhang, Gina, Kirsten, Nancy, Consigny, Paul, Dugan, Stephen, Park, Gene, Feezor, Christopher, Roorda, Wouter, Hossainy, Syed Faiyaz Ahmed
• Primary Examiner(s): Azpuru, Carlos
• Assistant Examiner(s): HAGOPIAN, CASEY SHEA
• Application Number:
  US11/322,282
• Publication Number:
  US 20060105019A1
• Time in Patent Office: 2,882 Days
• Field of Search: None
• US Class Current: 424/422
• 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 local drug-delivery system, comprising:

a polymeric coating which comprises an effective amount of everolimus, and

an effective amount of clobetasol for the treatment of a vascular disorder or a related disorder,

wherein the polymeric coating releases clobetasol completely or partially prior to releasing everolimus.

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

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

4. The drug-delivery system of claim 1, wherein the vascular disorder or the related disorder is restenosis, progression of atherosclerosis, or a combination thereof.

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

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

7. A method of treating vascular disease, comprising:

administering locally to a patient in need thereof a combination of

an effective amount of everolimus, and

an effective amount of clobetasol by a drug-delivery device,

wherein clobetasol is released completely or partially prior to releasing everolimus.

8. The method of claim 7, wherein the drug-delivery device is a stent.

9. The method of claim 7, wherein the vascular disease is restenosis, progression of atherosclerosis, or vascular plaque.