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Efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure Helicobacter pylori infection.
Hepatogastroenterology. 2002 Jul-Aug; 49(46):1006-9.H

Abstract

BACKGROUND/AIMS

Ranitidine bismuth citrate has recently been introduced for the treatment of H. pylori infection and obtains good eradication rates; however, eradication failures still appear in a considerable proportion of cases. The aim of this study was to compare the efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure H. pylori infection.

METHODOLOGY

We studied 423 consecutive H. pylori-positive patients. In 210 consecutive patients H. pylori infection was diagnosed for the first time (group A), while 213 consecutive patients were enrolled after failure of a first attempt to eradicate H. pylori (group B). All patients received ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for seven days. H. pylori-status was evaluated by means of histology and rapid urease test at entry and by 13C-urea breath test in all patients one month after treatment.

RESULTS

410/423 patients completed the study (202/210 in group A and 208/213 in group B). Two patients of group A and 1 patient of group B were withdrawn from the study due to poor compliance, 6 group A patients and 4 group B patients were lost to follow-up. In group A, after the end of treatment, 181/202 patients were H. pylori-negative (per-protocol analysis: 89.60% [C.I. 95%: 82-95%]; on intention-to-treat analysis: 86.19% [C.I. 95%; 76-92%]), side-effects occurred in 29 patients (13.80%); they were severe in 2 patients and the patients were withdrawn from the study. In group B, after the end of treatment, 200/208 patients were H. pylori-negative (per-protocol analysis: 95.15% [C.I. 95%; 92-100%], on intention-to-treat analysis: 93.89% [C.I. 95%; 89-98%), side-effects occurred in 11 patients (5.13%); they were slight or mild and did not require discontinuation of the treatment. The results of group B were statistically better than group A, both in eradication rate (P < 0.01) as well as both side-effects provoked (P < 0.01).

CONCLUSIONS

Ranitidine bismuth citrate-clarithromycin-amoxycillin is more effective when used as second-line therapy rather than when used as first-line therapy; second, ranitidine bismuth citrate-clarithromycin-amoxycillin shows lower and slighter side-effects when used as second-line therapy rather than when used as first-line therapy; finally, the excellent tolerability of ranitidine bismuth citrate + clarithromycin + amoxycillin influences positively the patients' compliance, both as first- and second-line therapy.

Authors+Show Affiliations

Division of Emergency, L. Bonomo Hospital, Andria, Italy. antotursi@tiscali.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

12143188

Citation

Tursi, Antonio, et al. "Efficacy and Tolerability of Ranitidine Bismuth Citrate Plus Amoxycillin and Clarithromycin as First- or Second-line Therapy to Cure Helicobacter Pylori Infection." Hepato-gastroenterology, vol. 49, no. 46, 2002, pp. 1006-9.
Tursi A, Brandimarte G, Giorgetti G, et al. Efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure Helicobacter pylori infection. Hepatogastroenterology. 2002;49(46):1006-9.
Tursi, A., Brandimarte, G., Giorgetti, G., Modeo, M. E., & Gigliobianco, A. (2002). Efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure Helicobacter pylori infection. Hepato-gastroenterology, 49(46), 1006-9.
Tursi A, et al. Efficacy and Tolerability of Ranitidine Bismuth Citrate Plus Amoxycillin and Clarithromycin as First- or Second-line Therapy to Cure Helicobacter Pylori Infection. Hepatogastroenterology. 2002 Jul-Aug;49(46):1006-9. PubMed PMID: 12143188.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure Helicobacter pylori infection. AU - Tursi,Antonio, AU - Brandimarte,Giovanni, AU - Giorgetti,GianMarco, AU - Modeo,Maria Ester, AU - Gigliobianco,Andrea, PY - 2002/7/30/pubmed PY - 2003/2/14/medline PY - 2002/7/30/entrez SP - 1006 EP - 9 JF - Hepato-gastroenterology JO - Hepatogastroenterology VL - 49 IS - 46 N2 - BACKGROUND/AIMS: Ranitidine bismuth citrate has recently been introduced for the treatment of H. pylori infection and obtains good eradication rates; however, eradication failures still appear in a considerable proportion of cases. The aim of this study was to compare the efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure H. pylori infection. METHODOLOGY: We studied 423 consecutive H. pylori-positive patients. In 210 consecutive patients H. pylori infection was diagnosed for the first time (group A), while 213 consecutive patients were enrolled after failure of a first attempt to eradicate H. pylori (group B). All patients received ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for seven days. H. pylori-status was evaluated by means of histology and rapid urease test at entry and by 13C-urea breath test in all patients one month after treatment. RESULTS: 410/423 patients completed the study (202/210 in group A and 208/213 in group B). Two patients of group A and 1 patient of group B were withdrawn from the study due to poor compliance, 6 group A patients and 4 group B patients were lost to follow-up. In group A, after the end of treatment, 181/202 patients were H. pylori-negative (per-protocol analysis: 89.60% [C.I. 95%: 82-95%]; on intention-to-treat analysis: 86.19% [C.I. 95%; 76-92%]), side-effects occurred in 29 patients (13.80%); they were severe in 2 patients and the patients were withdrawn from the study. In group B, after the end of treatment, 200/208 patients were H. pylori-negative (per-protocol analysis: 95.15% [C.I. 95%; 92-100%], on intention-to-treat analysis: 93.89% [C.I. 95%; 89-98%), side-effects occurred in 11 patients (5.13%); they were slight or mild and did not require discontinuation of the treatment. The results of group B were statistically better than group A, both in eradication rate (P < 0.01) as well as both side-effects provoked (P < 0.01). CONCLUSIONS: Ranitidine bismuth citrate-clarithromycin-amoxycillin is more effective when used as second-line therapy rather than when used as first-line therapy; second, ranitidine bismuth citrate-clarithromycin-amoxycillin shows lower and slighter side-effects when used as second-line therapy rather than when used as first-line therapy; finally, the excellent tolerability of ranitidine bismuth citrate + clarithromycin + amoxycillin influences positively the patients' compliance, both as first- and second-line therapy. SN - 0172-6390 UR - https://www.unboundmedicine.com/medline/citation/12143188/Efficacy_and_tolerability_of_ranitidine_bismuth_citrate_plus_amoxycillin_and_clarithromycin_as_first__or_second_line_therapy_to_cure_Helicobacter_pylori_infection_ L2 - https://medlineplus.gov/helicobacterpyloriinfections.html DB - PRIME DP - Unbound Medicine ER -