Source: Gut  |  Posted 9 years ago

Rofecoxib, administered at twice the recommended treatment dose, resulted in significantly fewer endoscopically detectable gastroduodenal ulcers in patients with rheumatoid arthritis (RA) than did treatment with naproxen.

Previous studies have demonstrated that rofecoxib is effective in treatment of osteoarthritis, with incidence of ulcers similar to placebo and significantly lower than non-selective NSAIDs. Additionally, significantly fewer upper gastrointestinal events were found to occur for RA patients treated daily with rofecoxib as compared to naproxen.

Dr. C. J. Hawkey of the University Hospital in Nottingham, United Kingdom, and colleagues conducted an endoscopic trial to further evaluate the gastrointestinal safety profiles of rofecoxib and naproxen for RA patients. Over a 12-week period, patients were randomised to receive a treatment regimen of rofecoxib 50 mg once daily, naproxen 500 mg twice daily, or placebo.

The final study population consisted of 509 RA patients between the ages of 21 and 85 years. Patients with ,[]Helicobacter pylori[] infection or gastroduodenal erosions were included in the study. However, patients were excluded on the basis of ulcers (oesophageal, gastric, or duodenal), pyloric obstruction, or erosive oesophagitis.

Researchers clinically evaluated patients at 3, 6, 9, and 12 weeks, and performed endoscopic examinations at baseline, 6 weeks, and 12 weeks.

While results showed that rofecoxib was well tolerated for the study duration, patients receiving naproxen showed a significant increase of ulceration (25.5%) in comparison to rofecoxib (6.8%) or placebo (2.9%), and were more likely to discontinue therapy due to adverse experience associated with the digestive system or abdominal discomfort.

Negative effects of rofecoxib therapy included a small increase in occurrence of hypertension. Overall, the number of clinical adverse events reported was similar for patients in all three treatment groups.

"Rofecoxib 50 mg daily (twice the dose recommended for this patient population) resulted in a lower incidence of endoscopically detected gastroduodenal ulcers and erosions than treatment with naproxen 500 mg twice daily," researchers concluded.