Combination of a NSAID and a PDE-4 inhibitor
View Patent ↗The invention relates to the combined use of a PDE4 inhibitor and a conventional NSAID in the treatment of an inflammatory disease and/or an inflammation-associated disorder while minimizing gastrointestinal side effects, such as gastric erosions and ulcer, which are frequently associated with the use of conventional NSAIDs. A preferred PDE 4 inhibitor for this combination is roflumilast or a derivative thereof. A preferred conventional NSAID for this combination is diclofenac or a derivative thereof.
1. A method of minimizing gastrointestinal side effects frequently associated with the use of conventional NSAIDs comprising the simultaneous, sequential or separate administration to a patient in need thereof of
(i) a first amount of 2-(2,6- dichlorophenyl) amino]benzeneacetic acid [INN: DICLOFENAC] or a pharmaceutically acceptable salt, ester, solvate, solvate of a salt, or solvate of an ester thereof; and
(ii) a second amount of 3-Cyclopropylmethoxy-4-difluoro methoxy-N-(3,5-dichloro pyrid-4- yl)-benzamide [INN: ROFLUMILAST] or a pharmaceutically acceptable salt, solvate, N-oxide, solvate of a salt, or solvate of an N-oxide thereof;
wherein the sum of the first and second amounts is a therapeutically effective amount.
2. The method according to claim 1 wherein (i) and (ii) are administered (A) simultaneously as a fixed dosage form, or (B) simultaneously, sequentially, or separately as discrete separate dosage forms.
3. The method according to claim 1 wherein the method is used in the treatment of an inflammatory disease.
4. The method according to claim 3 wherein the inflammatory disease is rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus, juvenile diabetes, inflammatory bowel disease, Crohn's disease, irritable bowel syndrome, or ulcerative colitis.