One-hundred and eighty-three patients with endoscopically proven duodenal ulcers, enrolled in this prospective, double-blind study, were randomly allocated to receive famotidine 40 mg once at night, 20 mg twice daily, 40 mg twice daily, or ranitidine 150 mg twice daily for 2 – 8 weeks. Pretreatment characteristics between the four groups were similar. After 4 weeks of treatment, among the famotidine-treated patients, 38 of 42 (90.5%) healed with the 40 mg once nightly regimen, 35 of 42 (83.3%) with 20 mg twice daily, and 37 of 41 (90.2%) with 40 mg twice daily. In the ranitidine group 40 of 43 patients (93.0%) healed. After 8 weeks of treatment, the respective data were: 97.6, 95.2, 100 and 93.0%. Different results between the famotidine groups and the ranitidine group were not statistically significant. All treatments were well tolerated and severe adverse events were rare. Famotidine 40 mg given once at night appears to be as safe and effective as conventional therapy with ranitidine, indicating the importance of overnight gastric acidity in the pathogenesis of duodenal ulcer disease.
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