COMPARISON OF THE PROTECTIVE EFFECTS OF R OXATIDINE AND MISOPROSTOL ON DICLOFENAC-INDUCED GASTRODUODENOPATHY - AN ENDOSCOPIC, CONTROLLED-STUDY IN HEALTHY-VOLUNTEERS

For prophylaxis of gastroduodenal lesions induced by non-steroidal ant irheumatic drugs (NSAID) acid-lowering as well as mucosa protective su bstances are used Direct comparison of both therapeutic regimens are l acking. In randomized parallel studies the gastroduodenal tolerability of 100 mg diclofenac daily in slow-release form was evaluated in the presence and absence of 150 mg roxatidine (CAS 78273-80-0) daily as we ll as in the presence of 75 mg bid roxatidine or 200 mu g bid misopros tol (CAS 59122-46-2). The drugs were taken over a period of 14 days. E ndoscopic controls were performed at entry as well as after 14 days of treatment. A quantitative damaging score was used. Study A: Both trea tment groups (n = 20) had at entry comparable mucosal damages: placebo / diclofenac: 0.9 +/- 0.1 (+/- SEM), roxatidine/diclofenac: 0.9 +/- 0 .1; after 14 days of treatment the score increased in the diclofenac / placebo group to 7.6 +/- 1.9 and, in the corresponding diclofenac / r oxatidine group, only to 2.1 +/- 0.9. The difference between the two t reatment groups after 14 days was significant (p < 0.05). Study B: Bot h treatment groups (n = 24) had comparable mucosal damages at entry: d iclofenac / roxatidin: 0.9 +/- 0.1, diclofenac / misoprostol: 0.8 +/- 0.1. Following 14 clays treatment with 100 mg diclofenac daily the dam aging score in both group rose to comparable levels: roxatidine group 2.1 +/- 0.7 and misoprostol group 2.0 +/- 0.4 (n.s.). The data suggest that for prophylaxis of NSAID-induced gastroduodenal lesions substanc es with different mechanism of action can be used. The findings underl ine the complex way by which NSAID can damage the mucosa of the upper gastrointestinal tract.