title: 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.affiliation: Hospital Militar Principal, Lisbon, Portugal.
authors.forename: J A
authors.initials: JA
authors.lastname: de Melo Gomes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004064:Digestive System / Q000187:drug effects* / Q000473:pathology; D004311:Double-Blind Method; D004338:Drug Combinations; D004724:Endoscopy; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D010003:Osteoarthritis / Q000188:drug therapy*
chemical_list: C078133:Arthrotec; D004338:Drug Combinations; D016595:Misoprostol; D004008:Diclofenac