Nm. Agrawal et al., MISOPROSTOL COADMINISTERED WITH DICLOFENAC FOR PREVENTION OF GASTRODUODENAL ULCERS - A ONE-YEAR STUDY, Digestive diseases and sciences, 40(5), 1995, pp. 1125-1131
The objective of this study was to determine the long-term efficacy of
misoprostol in preventing diclofenac-induced gastroduodenal ulcers in
rheumatoid arthritis and osteoarthritis patients. Three hundred eight
y-four patients who had an endoscopically confirmed gastric or duodena
l lesion that had healed with misoprostol therapy were randomized to r
eceive misoprostol or placebo coadministered with diclofenac for up to
52 weeks. Endoscopic examinations were repeated at weeks 12, 24, and
52. The development of a gastric and/or duodenal ulcer was considered
a prophylaxis failure. Results in the evaluable cohort of patients dem
onstrated that gastroduodenal ulcer incidences were lower with misopro
stol than placebo for all study periods (0-12 weeks, 7% vs 23%; 0-24 w
eeks, 11% vs 26%; and 0-52 weeks, 15% vs 31%). Misoprostol did not int
erfere with the antiarthritic effects of diclofenac. In conclusion, mi
soprostol coadministered with diclofenac for 12 months to patients wit
h rheumatoid arthritis or osteoarthritis significantly reduced the inc
idence of diclofenac induced gastroduodenal ulcers (P less than or equ
al to 0.018).