NIZATIDINE IN THERAPY AND PROPHYLAXIS OF NSAID-INDUCED GASTRODUODENALULCERS IN RHEUMATIC PATIENTS

269 patients with various rheumatic disorders who had been treated wit h non-steroidal anti-inflammatory drugs (NSAID) for at least three wee ks, were enrolled in this randomised double-blind multicenter trial. E ntry criteria were both the presence of an ulcer in gastric and/or duo denal mucosa (> 3 mm and < 20 mm in diameter) as well as dyspeptic sym ptoms. The patients had been treated with 150 mg nizatidine nocte (n = 86), 2 x 150 mg/d (n = 93) and 2 x 300 mg/d (n = 90) nizatidine. All patients continued to take their original NSAID-medication. The three nizatidine-groups had been well matched with respect to important pati ent characteristics. After 8 weeks of treatment more than 90% of gastr ic and duodenal ulcers had been healed under all three nizatidine-dosa ges. There was a tendency for higher healing rates in case of gastric ulcers after 4 weeks following the higher dose of nizatidine. Erosions in stomach and duodenum as well as esophagitis had been improved to a similar degree with all nizatidine doses. The same holds with respect to improvement of clinical symptoms such as epigastric pain, heartbur n etc. Consumption of additional antacids was similar in all three gro ups. In the subsequent prophylactic trial 237/221 patients had been fo llowed for 3/6 months. 116/107 received in addition to their continued antirheumatic medication nizatidine 150 mg nocte and 121/114 patients 2 x 150 mg nizatidine daily. The cumulative relapse rates within 6 mo nths averaged 5,5% in the low and 1,8% in the high dose group (n.s.). The safety of nizatidine had been estimated as good both in the therap eutic as well as in the preventive tial. No serious adverse events whi ch could be definitely attributed to nizatidine had been observed. Our data emphasize the efficacy of nizatidine both in the therapy as well as in the prevention of NSAID-induced gastroduodenal ulcers in the up per GI-tract.