Anti-proliferative and anti-inflammatory agent combination for treatment of vascular disorders with an implantable medical device
Drug-delivery systems such as drug-delivery stents having an anti-proliferative agent such as everolimus and an anti-inflammatory 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 an anti-proliferative agent;
a body structure of an implantable medical device; and
an effective amount of a steroidal anti-inflammatory agent or a non steroidal anti-inflammatory agent within the body structure of the device for the treatment of a vascular disorder or a related disorder;
wherein the anti-proliferative agent is everolimus and the steroidal or non-steroidal anti-inflammatory agent is clobetasol,
and wherein the ratio of the dose of everolimus to the dose of clobetasol is 1:1 to 3:1 on a molar basis.
2. A method of treating restenosis or vulnerable plaque of a blood vessel comprising:
administering to a patient an effective amount of an anti-proliferative agent; and
allowing an effective amount of a steroidal anti-inflammatory agent or a non steroidal anti-inflammatory agent to elute to a vessel from within a body structure of an implantable medical device, wherein the combination of the anti-proliferative and anti-inflammatory agents is for treatment of restenosis or vulnerable plaque;
wherein the anti-proliferative agent is everolimus and the steroidal or non-steroidal anti-inflammatory agent is clobetasol,
and wherein the ratio of the dose of everolimus to the dose of clobetasol is 1:1 to 3:1 on a molar basis.
3. A drug-delivery system, comprising:
an effective amount of everolimus;
a biodegradable body structure of an implantable medical device;
an effective amount of clobetasol mixed or dispersed within the biodegradable body structure of the implantable medical device for the treatment of a vascular disorder or a related disorder, wherein the clobetasol is released based on the degradation of the body structure in a patient;
a coating completely surrounding the exterior surface of a structural element of the biodegradable body structure, wherein the coating contains at least a portion of the everolimus;
wherein the ratio of the dose of everolimus to the dose of clobetasol is 1:1 to 3:1 on a molar basis.
4. A method of treating restenosis or vulnerable plaque of a blood vessel comprising:
administering to a patient an effective amount of everolimus; and
allowing an effective amount of clobetasol mixed or dispersed within a bioabsorbable polymer body structure of an implantable medical device to release to a vessel from the implantable medical device, wherein the combination of everolimus and clobetasol is for treating restenosis or vulnerable plaque,
a coating completely surrounding the exterior surface of a structural element of the bioabsorbable body structure, wherein the coating contains at least a portion of the everolimus which is administered by eluting from the coating; and
wherein the ratio of the dose of everolimus to the dose of clobetasol is 1:1 to 3:1 on a molar basis.