Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2001-07-26
2004-04-06
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
C514S173000, C514S175000, C514S456000, C514S432000
Reexamination Certificate
active
06716829
ABSTRACT:
FIELD OF THE INVENTION
This invention is in the field of preventing or treating cardiovascular disorders. More specifically, this invention relates to the use of aldosterone antagonist and cyclooxygenase-2 inhibitor combination therapy in preventing or treating cardiovascular disease including atherosclerosis.
BACKGROUND OF THE INVENTION
Prostaglandins play a major role in the inflammation process and the inhibition of prostaglandin production, especially production of PGG
2
, PGH
2
and PGE
2
, has been a common target of anti-inflammatory drug discovery. However, common non-steroidal anti-inflammatory drugs (NSAID's) that are active in reducing the prostaglandin-induced pain and swelling associated with the inflammation process are also active in affecting other prostaglandin-regulated processes not associated with the inflammation process. Thus, use of high doses of most common NSAID's can produce severe side effects, including life threatening ulcers, that limit their therapeutic potential. An alternative to NSAID's is the use of corticosteroids, which also produce severe adverse effects, especially when long term therapy is involved.
NSAIDs have been found to prevent the production of prostaglandins by inhibiting enzymes in the human arachidonic acid/prostaglandin pathway, including the enzyme cyclooxygenase (COX). The recent discovery of an inducible enzyme associated with inflammation (named “cyclooxygenase-2 (COX-2)” or “prostaglandin G/H synthase II”) provides a viable target of inhibition which more effectively reduces inflammation and produces fewer and less drastic side effects.
Recently, the role of inflammation in cardiovascular diseases is becoming more understood. Ridker et al. (
New Eng. J. Med
., 336, 973-9 (1997)) describes a possible role of inflammation in cardiovascular disease. J. Boyle (
J. Path
., 181, 93-9 (1997)) describes the association of plaque rupture and atherosclerotic inflammation.
Compounds which selectively inhibit cyclooxygenase-2 have been described in U.S. Pat. Nos. 5,380,738, 5,344,991, 5,393,790, 5,434,178, 5,474,995, 5, 510,368 and WO documents WO96/06840, WO96/03388, WO96/03387, WO96/19469, WO96/25405, WO95/15316, WO94/15932, WO94/27980, WO95/00501, WO94/13635, WO94/20480, and WO94/26731.
[Pyrazol-1-yl]benzenesulfonamides have been described as inhibitors of cyclooxygenase-2 and have shown promise in the treatment of inflammation, arthritis, and pain, with minimal side effects in pre-clinical and clinical trials. Their use for treating inflammation in vascular disease has been described in U.S. Pat. No. 5,466,823.
The present invention is directed to the use of aldosterone antagonist and cyclooxygenase-2 inhibitor combination therapy for the prevention or treatment of inflammation related cardiovascular disorders. More specifically, this invention relates to the use of aldosterone antagonist and cyclooxygenase-2 inhibitor combination therapy in preventing cardiovascular disease.
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Blasi Eileen R.
McMahon Ellen
Rocha Ricardo
Zack Marc
Criares Theodore J.
Pharmacia Corporation
Polster, II Philip B.
Schuh Joseph R.
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