ENDOSCOPIC EVALUATION OF THE LONG-TERM EFFECTS OF DICLOFENAC SODIUM AND NAPROXEN IN ELDERLY PATIENTS WITH ARTHRITIS

A randomised, double-blind, parallel-group study was conducted to evaluate, by endoscopic examination, the effects of nonsteroidal anti-inflammatory drug treatment on gastric and duodenal mucosa. Men and women, aged 55 years or older, with chronic osteoarthritis or rheumatoid arthritis, requiring anti-inflammatory therapy for at least 3 months prior to the study, were enrolled. Patients were randomised to receive either diclofenac sodium 150 mg/day or naproxen 1000 mg/day. Patients were permitted to take paracetamol as a rescue analgesic and antacid tablets. Endoscopy revealed an increase in gastrointestinal findings after treatment (compared with baseline) in 29% of the diclofenac sodium group versus 65% of the naproxen group (p<0.001). A total of 111 patients treated with diclofenac sodium and 113 treated with naproxen were evaluated for efficacy. 25 of the 111 (22.5%) patients who received diclofenac sodium and 27 of the 113 (23.9%) who received naproxen had a history of ulcers. Of the patients with a history of ulcers, 23 treated with diclofenac sodium and 25 treated with naproxen had both pre- and post-treatment endoscopies. Six of those 23 (26.1%) patients in the diclofenac sodium group and 18 of the 25 (72%) in the naproxen group had an increase in endoscopic findings post-treatment. The incidence of gastrointestinal symptoms was significantly higher among patients treated with naproxen than among those treated with diclofenac sodium (p = 0.019). Of the 101 patients treated with diclofenac sodium and the 103 patients treated with naproxen who were evaluated for safety, more ulcers occurred in the naproxen group (41; 40%) than in the diclofenac sodium group (13; 12.9%). Ulcers greater than or equal to 5mm were more frequent in the naproxen group (18%) than in the diclofenac sodium group (8%). These findings demonstrate a significantly greater incidence of gastric and duodenal ulcers in patients treated with naproxen, as well as a greater incidence of endoscopic evidence of mucosal irritation/damage of the upper gastrointestinal mucosa, than in patients treated with diclofenac sodium.