Sh. Roth et al., ENDOSCOPIC EVALUATION OF THE LONG-TERM EFFECTS OF DICLOFENAC SODIUM AND NAPROXEN IN ELDERLY PATIENTS WITH ARTHRITIS, Clinical drug investigation, 9(3), 1995, pp. 171-179
A randomised, double-blind, parallel-group study was conducted to eval
uate, by endoscopic examination, the effects of nonsteroidal anti-infl
ammatory drug treatment on gastric and duodenal mucosa. Men and women,
aged 55 years or older, with chronic osteoarthritis or rheumatoid art
hritis, requiring anti-inflammatory therapy for at least 3 months prio
r to the study, were enrolled. Patients were randomised to receive eit
her diclofenac sodium 150 mg/day or naproxen 1000 mg/day. Patients wer
e permitted to take paracetamol as a rescue analgesic and antacid tabl
ets. Endoscopy revealed an increase in gastrointestinal findings after
treatment (compared with baseline) in 29% of the diclofenac sodium gr
oup versus 65% of the naproxen group (p<0.001). A total of 111 patient
s treated with diclofenac sodium and 113 treated with naproxen were ev
aluated for efficacy. 25 of the 111 (22.5%) patients who received dicl
ofenac sodium and 27 of the 113 (23.9%) who received naproxen had a hi
story 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 di
clofenac sodium group and 18 of the 25 (72%) in the naproxen group had
an increase in endoscopic findings post-treatment. The incidence of g
astrointestinal symptoms was significantly higher among patients treat
ed 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 ul
cers occurred in the naproxen group (41; 40%) than in the diclofenac s
odium group (13; 12.9%). Ulcers greater than or equal to 5mm were more
frequent in the naproxen group (18%) than in the diclofenac sodium gr
oup (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 irritati
on/damage of the upper gastrointestinal mucosa, than in patients treat
ed with diclofenac sodium.