Titre du document / Document title

Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip : A randomized, placebo controlled trial

Auteur(s) / Author(s)

Arthrotec Osteorthritis Study Group
BOCANEGRA T. S. ; WEAVER A. L. ; TINDALL E. A. ; SIKES D. H. ; BALL J. A. ; WALLEMARK C. B. ; GEIS G. S. ; FORT J. G. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

Arthritis Center of Nebraska, Lincoln, Nebraska, ETATS-UNIS
Portland Medical Associates, Portland, Oregon, ETATS-UNIS
Florida Medical Clinic, Zephyrhills, Florida, ETATS-UNIS
G.D. Searle & Co., Skokie, Illinois, ETATS-UNIS

Résumé / Abstract

Objective. Gastric (GU) and duodenal ulcers (DU) are common adverse effects of nonsteroidal antiinflammatory drugs (NSAID). Endoscopically diagnosed upper gastrointestinal (GI) ulceration occurs in about 24% of longterm NSAID users. Coadministration of misoprostol with the NSAID reduces the incidence of NSAID induced GU and DU and their complications. However, compliance is limited by the different dosing regimens of misoprostol and NSAID and GI symptoms associated with misoprostol at its recommended qid dose. We compared the efficacy. safety, and incidence of endoscopic upper GI ulceration associated with the administration of 2 combinations of diclofenac (50 or 75 mg) and misoprostol 200 μg (D50/M200 tid. D75/M200 bid), diclofenac 75 mg bid, and placebo in a 6 week, randomized, double blind study in patients with osteoarthritis (OA) of the knee or hip. Methods. A total of 572 patients with symptomatic OA of the knee or hip and history of GU. DU, or 10 or more erosions were randomized to receive D50/M200 tid, D75/M200 bid, diclofenac 75 mg bid, or placebo for 6 weeks. Arthritis assessments were performed at baseline. 2, and 6 weeks. and upper GI endoscopies at baseline and end of treatment. Results. All active treatment groups were significantly better than placebo, at all visits, in improving OA symptoms. There were no significant differences in arthritis efficacy between the diclofenac/ misoprostol combinations and diclofenac. However, endoscopically diagnosed GU and/or DU were significantly less frequent in patients receiving D50/M200 tid (8%), D75/M200 bid (7%). and placebo (4%) compared to dicrofenac 75 mg bid (17%). Adverse events were not different between the active treatment groups, except for higher incidences of flatulence with D75/M200 and diarrhea with D50/M200. Conclusion. Diclofenac 50 mg/misoprostol 200 μg tid and diclofenac 75 mg/misoprostol 200 μg bid are as efficacious as diclofenac 75 mg bid in the treatment of OA, but are associated with a significantly lower incidence of gastric and/or duodenal ulcers.

Revue / Journal Title

Journal of rheumatology   ISSN 0315-162X   CODEN JRHUA9 

Source / Source

1998, vol. 25, n^o8, pp. 1602-1611 (47 ref.)

Langue / Language

Anglais

Editeur / Publisher

Journal of Rheumatology Publishing, Toronto, ON, CANADA  (1974) (Revue)

Mots-clés anglais / English Keywords

Osteoarthritis ; Knee ; Treatment ; Diclofenac ; Drug combination ; Chemotherapy ; Misoprostol ; Treatment efficiency ; Toxicity ; Ulcer ; Gastroduodenal ; Human ; Clinical trial ; Lower limb ; Arylacetic acid derivatives ; Prostaglandin derivatives ; Diseases of the osteoarticular system ; Arthropathy ; Degenerative disease ; Knee disease ; Digestive diseases ; Gastric disease ; Intestinal disease ;

Mots-clés français / French Keywords

Arthrose ; Genou ; Traitement ; Diclofénac ; Association médicamenteuse ; Chimiothérapie ; Misoprostol ; Efficacité traitement ; Toxicité ; Ulcère ; Gastroduodénal ; Homme ; Essai clinique ; Membre inférieur ; Arylacétique acide dérivé ; Prostaglandine dérivé ; Système ostéoarticulaire pathologie ; Arthropathie ; Maladie dégénérative ; Genou pathologie ; Appareil digestif pathologie ; Estomac pathologie ; Intestin pathologie ;

Mots-clés espagnols / Spanish Keywords

Artrosis ; Rodilla ; Tratamiento ; Diclofenaco ; Asociación medicamentosa ; Quimioterapia ; Misoprostol ; Eficacia tratamiento ; Toxicidad ; Ulcera ; Gastroduodenal ; Hombre ; Ensayo clínico ; Miembro inferior ; Arilacético ácido derivado ; Prostaglandina derivado ; Sistema osteoarticular patología ; Artropatía ; Enfermedad degenerativa ; Rodilla patología ; Aparato digestivo patología ; Estómago patología ; Intestino patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 16024, 35400007002786.0270