EFFICACY AND SAFETY OF 3 7-DAY HELICOBACTER-PYLORI ERADICATION REGIMENS CONTAINING RANITIDINE BISMUTH CITRATE

Background: This multicentre, randomized study was designed to assess the clinical efficacy, safety and tolerability of three novel 7-day tr iple therapies containing ranitidine bismuth citrate (RBC) and two ant ibiotics. Methods: We studied patients with non-ulcer dyspepsia and ga stritis who were randomly assigned to one of three treatment regimens given for 7 days in a b.d. dosing schedule: RBC 400 mg plus clarithrom ycin 250 mg and tinidazole 500 mg (RBCCT); RBC 400 mg plus clarithromy cin 500 mg and amoxycillin 1 g (RBCCA); RBC 400 mg plus tinidazole 500 mg and amoxycillin 1 g (RBCTA), H. pylori status was determined by CL O-test, histology and C-13-urea breath test. A repeat breath test was performed at least 28 days after completion of therapy to assess eradi cation. Results: One hundred and fifty-seven patients were eligible fo r intention-to-treat analysis (ITT) and 140 patients completed the stu dy and returned for assessment of eradication. Intention-to-treat cure rates were 78% with RBCCT, 71% with RBCCA and 61% with RBCTA, An all- patients-treated analysis (APT), performed on evaluable patients, demo nstrated eradication rates of 85% with RBCCT, 81% with RBCCA and 70% w ith RBCTA. No statistically significant difference was found between t reatment groups. Twenty-four patients experienced side-effects, but in only seven cases was treatment discontinued due to adverse events, Co nclusions: A 7-day course of RBC, clarithromycin and either tinidazole or amoxycillin provides a good rate of H. pylori eradication. Three n ovel RBC-based triple therapies proved to be safe and well tolerated, with discontinuations due to side-effects occurring in less than 5% of cases.