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Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate.
Aliment Pharmacol Ther 1998; 12(6):533-7AP

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 13C-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.

Authors+Show Affiliations

Gastroenterology Unit, Policlinico S. Orsola, Bologna, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9678812

Citation

Ricciardiello, L, et al. "Efficacy and Safety of Three 7-day Helicobacter Pylori Eradication Regimens Containing Ranitidine Bismuth Citrate." Alimentary Pharmacology & Therapeutics, vol. 12, no. 6, 1998, pp. 533-7.
Ricciardiello L, Cannizzaro O, D'Angelo A, et al. Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate. Aliment Pharmacol Ther. 1998;12(6):533-7.
Ricciardiello, L., Cannizzaro, O., D'Angelo, A., Ederle, A., Gerace, G., Iaquinto, G., ... Roda, E. (1998). Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate. Alimentary Pharmacology & Therapeutics, 12(6), pp. 533-7.
Ricciardiello L, et al. Efficacy and Safety of Three 7-day Helicobacter Pylori Eradication Regimens Containing Ranitidine Bismuth Citrate. Aliment Pharmacol Ther. 1998;12(6):533-7. PubMed PMID: 9678812.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate. AU - Ricciardiello,L, AU - Cannizzaro,O, AU - D'Angelo,A, AU - Ederle,A, AU - Gerace,G, AU - Iaquinto,G, AU - Reina,G, AU - Scarpulla,G, AU - Spadaccini,A, AU - Olivieri,A, AU - Tosatto,R, AU - Fossi,S, AU - Pozzato,P, AU - Zagari,M, AU - Bazzoli,F, AU - Roda,E, PY - 1998/7/25/pubmed PY - 1998/7/25/medline PY - 1998/7/25/entrez SP - 533 EP - 7 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 12 IS - 6 N2 - 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 13C-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. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9678812/Efficacy_and_safety_of_three_7_day_Helicobacter_pylori_eradication_regimens_containing_ranitidine_bismuth_citrate_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=1998&volume=12&issue=6&spage=533 DB - PRIME DP - Unbound Medicine ER -