The Safety of Arthrotec® in Patients with Rheumatoid Arthritis or Osteoarthritis: An Assessment of the Upper Gastrointestinal Tract by Endoscopy

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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 μg 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).