Compositions comprising nebivolol

• US 7,838,552 B2
• Filed: 11/15/2005
• Issued: 11/23/2010
• Est. Priority Date: 06/04/2004
• Status: Active Grant

• Current Assignee: Mylan Laboratories Incorporated (Pfizer Inc.)
• Original Assignee: Forest Laboratories Holdings Limited (Abbvie Incorporated)
• Inventors: Davis, Eric, Bottini, Peter Bruce, Shaw, Andrew, O'Donnell, John P., Mason, R. Preston
• Primary Examiner(s): Krass; Frederick
• Assistant Examiner(s): Webb; Walter E
• Application Number:
  US11/273,992
• Publication Number:
  US 20080161296A1
• Time in Patent Office: 1,834 Days
• Field of Search: 514/217.03, 514/456
• US Class Current: 514/456
• 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 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 31/54 having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.

Claims

1. A method of treating hypertension comprising administering to a subject in need thereof a composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of at least one other cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof, wherein the effectiveness of the composition when administered to the subject is greater than treatment with nebivolol or a cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof administered alone.

3. The method of claim 1 wherein the cardiovascular active agent is olmesartan or a pharmaceutically acceptable salt thereof.

4. The method of claim 1 wherein the cardiovascular active agent is valsartan or a pharmaceutically acceptable salt thereof.

5. The method of claim 1 wherein the cardiovascular active agent is losartan or a pharmaceutically acceptable salt thereof.

2. A method of treating a hypertension comprising administering to a subject in need thereof a composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof, and between about 1 mg to about 1200 mg of an angiotensin II receptor antagonist (ARB), wherein the ARB is selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof, wherein the treatment is at least 10% more effective than treatment with nebivolol or an ARB selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof administered alone.

6. The method of claim 2 wherein the ARB is olmesartan or a pharmaceutically acceptable salt thereof.

7. The method of claim 2 wherein the ARB is valsartan or a pharmaceutically acceptable salt thereof.

8. The method of claim 2 wherein the ARB is losartan or a pharmaceutically acceptable salt thereof.

9. A method of treating hypertension comprising administering to a subject in need thereof a composition comprising between about 0.125 mg to about 40 mg nebivolol or a pharmaceutically acceptable salt thereof and between about 1 mg to about 1200 mg of a cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof wherein the composition provides a higher therapeutic index than nebivolol or a cardiovascular active agent selected from the group consisting of valsartan, losartan, olmesartan, or a pharmaceutically acceptable salt thereof administered alone.

10. The method of claim 9 wherein the cardiovascular active agent is olmesartan or a pharmaceutically acceptable salt thereof.

11. The method of claim 9 wherein the cardiovascular active agent is valsartan or a pharmaceutically acceptable salt thereof.

12. The method of claim 9 wherein the cardiovascular active agent is losartan or a pharmaceutically acceptable salt thereof.