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.