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

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.

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.