| Title | The safety of Arthrotec in patients with rheumatoid arthritis or osteoarthritis: an assessment of the upper gastrointestinal tract by endoscopy. | | Author(s) | de Melo Gomes JA | | Institution | Hospital Militar Principal, Lisbon, Portugal. | | Source | Scand J Rheumatol Suppl 1992.:23-31. | | MeSH | Administration, Oral
Adult
Aged
Aged, 80 and over
Arthritis, Rheumatoid
Diclofenac
Digestive System
Double-Blind Method
Drug Combinations
Endoscopy
Female
Gastrointestinal Diseases
Humans
Intestinal Mucosa
Male
Middle Aged
Misoprostol
Osteoarthritis
| | Abstract | Two double-blind comparative studies were conducted to determine the upper gastrointestinal safety of Arthrotec, a combination of 50 mg of diclofenac and 200 micrograms of misoprostol versus 50 mg of diclofenac. In one study, rheumatoid arthritis patients were randomly given Arthrotec or diclofenac 2 or 3 times daily for 12 weeks. Endoscopy was performed before and after treatment. At the termination of treatment, among the 290 patients with rheumatoid arthritis, gastroduodenal ulcers were found in 4% of the Arthrotec-treated patients and in 11% of the diclofenac-treated patients (P = 0.034). In the second study, osteoarthritis patients were randomly given Arthrotec or diclofenac 2 or 3 times daily for 4 weeks. Endoscopy was performed before and after treatment. Among the 329 patients with osteoarthritis, gastroduodenal ulcers were found in none of the Arthrotec patients and in 4% of the diclofenac patients (P = 0.015). | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Randomized Controlled Trial
| | PubMed ID | 1439621 |
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