Background: This multicentre, randomized study was designed to assess the clinical efficacy, safety and tolerability of three novel 7-day triple therapies containing ranitidine bismuth citrate (RBC) and two antibiotics.Methods: We studied patients with non-ulcer dyspepsia and gastritis who were randomly assigned to one of three treatment regimens given for 7 days in a b.d. dosing schedule: RBC 400 mg plus clarithromycin 250 mg and tinidazole 500 mg (RBCCT); RBC 400 mg plus clarithromycin 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 CLO-test, histology and C-13-urea breath test. A repeat breath test was performed at least 28 days after completion of therapy to assess eradication.Results: One hundred and fifty-seven patients were eligible for intention-to-treat analysis (ITT) and 140 patients completed the study 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, demonstrated eradication rates of 85% with RBCCT, 81% with RBCCA and 70% with RBCTA. No statistically significant difference was found between treatment groups. Twenty-four patients experienced side-effects, but in only seven cases was treatment discontinued due to adverse events,Conclusions: A 7-day course of RBC, clarithromycin and either tinidazole or amoxycillin provides a good rate of H. pylori eradication. Three novel RBC-based triple therapies proved to be safe and well tolerated, with discontinuations due to side-effects occurring in less than 5% of cases.

Ricciardiello, L., Cannizzaro, O., D'Angelo, A., Ederle, A., Gerace, G., Iaquinto, G., et al. (1998). Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 12(6), 533-537.

Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate

Ricciardiello, L
;
Gerace, G;Reina, G;Spadaccini, A;Zagari, M;Bazzoli, F;
1998

Abstract

Background: This multicentre, randomized study was designed to assess the clinical efficacy, safety and tolerability of three novel 7-day triple therapies containing ranitidine bismuth citrate (RBC) and two antibiotics.Methods: We studied patients with non-ulcer dyspepsia and gastritis who were randomly assigned to one of three treatment regimens given for 7 days in a b.d. dosing schedule: RBC 400 mg plus clarithromycin 250 mg and tinidazole 500 mg (RBCCT); RBC 400 mg plus clarithromycin 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 CLO-test, histology and C-13-urea breath test. A repeat breath test was performed at least 28 days after completion of therapy to assess eradication.Results: One hundred and fifty-seven patients were eligible for intention-to-treat analysis (ITT) and 140 patients completed the study 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, demonstrated eradication rates of 85% with RBCCT, 81% with RBCCA and 70% with RBCTA. No statistically significant difference was found between treatment groups. Twenty-four patients experienced side-effects, but in only seven cases was treatment discontinued due to adverse events,Conclusions: A 7-day course of RBC, clarithromycin and either tinidazole or amoxycillin provides a good rate of H. pylori eradication. Three novel RBC-based triple therapies proved to be safe and well tolerated, with discontinuations due to side-effects occurring in less than 5% of cases.
1998
Ricciardiello, L., Cannizzaro, O., D'Angelo, A., Ederle, A., Gerace, G., Iaquinto, G., et al. (1998). Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 12(6), 533-537.
Ricciardiello, L; Cannizzaro, O; D'Angelo, A; Ederle, A; Gerace, G; Iaquinto, G; Reina, G; Scarpulla, G; Spadaccini, A; Olivieri, A; Tosatto, R; Fossi, S; Pozzato, P; Zagari, M; Bazzoli, F; Roda, E
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/903608
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