Ranitidine Bismuth Citrate With Clarithromycin Given Twice Daily Effectively EradicatesHelicobacter pyloriand Heals Duodenal Ulcers


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Abstract

Objective:Ranitidine bismuth citrate (RBC) b.i.d. with Clarithromycin q.i.d. eradicates Helicobacter pylori (H. pylori) in 82–94% of patients, and heals duodenal ulcers in 88–90% of patients. This double blind, placebo-controlled study examines the efficacy of a simpler b.i.d. treatment regimen, and examines the potential benefit of including a second antibiotic, metronidazole, to the b.i.d. treatment regimen.Methods:A total of 648 patients with active duodenal ulcer received RBC 400 mg b.i.d. for 4 wk, coprescribed with Clarithromycin 250 mg q.i.d., Clarithromycin 500 mg b.i.d., or Clarithromycin 500 mg b.i.d. with metronidazole 400 mg b.i.d. for the first 2 wk of treatment. Endoscopies were performed prestudy, after 4 wk of treatment, and at least 4 wk posttreatment. H. pylori status was assessed by CLOtest, 13C-urea breath test (UBT), and histology prestudy, and by UBT and histology at least 4 wk posttreatment. Adverse events were recorded at each visit.Results:All three regimens were highly effective and well tolerated. H. pylori eradication rates were 84–94% and duodenal ulcer healing rates were 92–96% (observed data). Highest H. pylori eradication and ulcer healing rates were achieved with RBC 400 mg b.i.d. with Clarithromycin 500 mg b.i.d.Conclusion:Ranitidine bismuth citrate with Clarithromycin 500 mg b.i.d. provides an effective, simple and well tolerated regimen for the eradication of H. pylori and healing of duodenal ulcers.

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