A comparison of severe gastric damage as a result of pirprofen and naproxen treatment in rheumatoid arthritis: a controlled endoscopic study

OBJECTIVE: The aim of this controlled endoscopic study was to compare the therapeutic efficacy and the gastric tolerance of two nonsteroidal anti-inflammatory drugs, pirprofen versus naproxen. DESIGN: A randomized endoscopic double-blind double-dummy study. SETTING: The gastrointestinal unit of a teaching hospital. SUBJECTS: Forty patients suffering from rheumatoid arthritis were enrolled. After an initial upper gastrointestinal endoscopy to rule out the presence of gastric mucosal lesions, the patients were randomly allocated in a double-blind, double-dummy manner, to receive either pirprofen (400 mg t.i.d.) or naproxen (500 mg b.i.d.) for 4 weeks; endoscopic control followed this treatment period, or was anticipated in the event of painful dyspepsia. INTERVENTIONS: Endoscopy at the beginning of the study and at 4 weeks, or anticipated in the event of painful dyspepsia. MAIN OUTCOME MEASURES: Primary outcome measure of the study was the possibility that pirprofen was less toxic to the gastric mucosa than naproxen, and at least as effective. RESULTS: Both drugs proved effective in relieving clinical symptoms, without a statistically significant difference. Gastric mucosa lesions were observed in 90% of pirprofen-treated patients and in 60% of those on naproxen (P = 0.03). The most severe lesions (grades 3 and 4) were found in 65% of subjects treated with pirprofen, as opposed to 15% of those treated with naproxen (P = 0.001). CONCLUSIONS: This study shows that pirprofen is at least as active as naproxen in relieving rheumatic symptoms, but its administration results in a significantly severe degree of gastric damage.