Nizatidine versus ranitidine in the treatment of peptic ulcer disease: report on the Dutch investigation as part of a European multicentre trial.

The efficacy and safety of nizatidine was evaluated in comparison with ranitidine in 230 patients with endoscopically documented gastric (71) or duodenal (159) ulcers. Gastric ulcer patients who satisfied all criteria for inclusion and exclusion were randomly allocated to nizatidine 300 mg nocte, 150 mg b.d. or ranitidine 150 mg b.d., duodenal ulcer patients to nizatidine 300 mg nocte or ranitidine 300 mg nocte. Endoscopic healing was defined as complete epithelialisation of all mucosal lesions. Endoscopy was performed at 4 and, if not healed, at 8 weeks. Healing rates were shown to be comparable for all treatment regimens. In both duodenal ulcer treatment groups, and with both drugs, healing was negatively influenced by ulcer size, ulcer number, smoking habits and a disease duration of 5 years or more. Few side effects were noted. Nizatidine, administered as a 300 mg nocte and as a 150 mg b.d. dose appeared to be a safe H2 antagonist and was as effective as ranitidine in the treatment of duodenal and gastric ulceration.