The safety of Arthrotec in patients with rheumatoid arthritis or osteoarthritis: an assessment of the upper gastrointestinal tract by endoscopy.

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).

• Authors: J A de Melo Gomes
• Journal: Scandinavian journal of rheumatology. Supplement (Scand J Rheumatol Suppl) Vol. 96 Pg. 23-31 ( 1992) ISSN: 0301-3847 [Print] Norway
• PMID: 1439621 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Arthrotec
• Drug Combinations
• Misoprostol
• Diclofenac

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Arthritis, Rheumatoid (drug therapy)
• Diclofenac (administration & dosage, adverse effects, therapeutic use)
• Digestive System (drug effects, pathology)
• Double-Blind Method
• Drug Combinations
• Endoscopy
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Intestinal Mucosa (drug effects, pathology)
• Male
• Middle Aged
• Misoprostol (administration & dosage, adverse effects, therapeutic use)
• Osteoarthritis (drug therapy)