Nizatidine and ranitidine in the short-term treatment of duodenal ulcer: a cooperative double-blind study of once-daily bedtime administration.

The aim of the present study was to assess the clinical efficacy and safety of a new H2-antagonist, nizatidine (N), administered as a single bedtime dose of 300 mg, compared with ranitidine (R) at the same dosage, in the short-term treatment of duodenal ulcer. One hundred forty one patients were included in the study: 70 were treated with N and 71 with R. During the study, three patients were withdrawn for unwanted effects not related to the treatment, and therefore, 69 patients per group were studied. After 4 wk of treatment, 58 patients treated with N (84.1%) and 55 in the group treated with R (77.5%), showed complete endoscopic ulcer healing (p greater than 0.5). The corresponding figure after 8 wk of therapy was 64 (94.2%) and 65 (94.2%) (p greater than 0.5). A similar effect on pain relief was observed: 42% of patients in both groups became asymptomatic after 4 wk. After 8 wk, the percentage rose to 84.2% in the group treated with N and 87.0% in the R group (p greater than 0.5). In both groups, only minor side effects occurred, not requiring drug discontinuation. These data show that nizatidine in a single bedtime dose of 300 mg is as effective and safe as ranitidine at the same dosage, and represents therefore a valid alternative to the usual H2-antagonists.