Abstract | OBJECTIVE: Gastric (GU) and duodenal ulcers (DU) are common adverse effects of nonsteroidal anti-inflammatory 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 q.i.d. 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 microg (D50/ M200 t.i.d., D75/ M200 b.i.d.), diclofenac 75 mg b.i.d., 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 t.i.d., D75/ M200 b.i.d., diclofenac 75 mg b.i.d., 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 t.i.d. (8%), D75/ M200 b.i.d. (7%), and placebo (4%) compared to diclofenac 75 mg b.i.d. (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:
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Authors | T S Bocanegra, A L Weaver, E A Tindall, D H Sikes, J A Ball, C B Wallemark, G S Geis, J G Fort |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 25
Issue 8
Pg. 1602-11
(Aug 1998)
ISSN: 0315-162X [Print] Canada |
PMID | 9712107
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Misoprostol
- Diclofenac
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Topics |
- Adult
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects, therapeutic use)
- Diclofenac
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Duodenal Ulcer
(chemically induced)
- Endoscopy, Gastrointestinal
- Female
- Humans
- Male
- Middle Aged
- Misoprostol
(administration & dosage, adverse effects, therapeutic use)
- Osteoarthritis, Hip
(drug therapy)
- Osteoarthritis, Knee
(drug therapy)
- Outcome Assessment, Health Care
- Stomach Ulcer
(chemically induced)
- Treatment Failure
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