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Efficacy of reduced-dose regimen of a capsule containing bismuth subcitrate, metronidazole, and tetracycline given with amoxicillin and esomeprazole in the treatment of Helicobacter Pylori infection.

ABSTRACT: It is well known that triple therapy for Helicobacter pylori is losing efficacy worldwide. A regimen containing proton pump inhibitor and multiple-dose capsules of bismuth, metronidazole, and tetracycline has proven efficacy. In addition, a literature review on dosage of previous regimens shows that half-dose clarithromycin-based regimens are equally effective to full-dose regimens. However, the applicability of dose reduction to bismuth-based therapy is unknown. This communication shows that a reduced-dose bismuth-based regimen fails to achieve acceptable eradication rates.

SUBMITTER: Harb AH

PROVIDER: S-EPMC4315687 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Efficacy of reduced-dose regimen of a capsule containing bismuth subcitrate, metronidazole, and tetracycline given with amoxicillin and esomeprazole in the treatment of Helicobacter Pylori infection.

Harb Ali H AH El Reda Zeinab D ZD Sarkis Fayez S FS Chaar Hani F HF Sharara Ala I AI

United European gastroenterology journal 20150201 1

It is well known that triple therapy for Helicobacter pylori is losing efficacy worldwide. A regimen containing proton pump inhibitor and multiple-dose capsules of bismuth, metronidazole, and tetracycline has proven efficacy. In addition, a literature review on dosage of previous regimens shows that half-dose clarithromycin-based regimens are equally effective to full-dose regimens. However, the applicability of dose reduction to bismuth-based therapy is unknown. This communication shows that a ...[more]

PMID: 25653863

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Project description:BackgroundHigh-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment.MethodsThis was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance.ResultsA total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (-9.19% in the ITT analysis, - 9.21% in the MITT analysis, and -9.73% in the PP analysis) was greater than the predefined non-inferiority margin of -10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients' compliance were similar between the two groups.ConclusionsFourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region.Trial registrationClinicaltrials.gov, NCT04678492.

Project description:BackgroundThere has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation.ObjectiveTo evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy.MethodsData were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterologia REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line.ResultsFinally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases.ConclusionsSingle-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

Dataset Information

Efficacy of reduced-dose regimen of a capsule containing bismuth subcitrate, metronidazole, and tetracycline given with amoxicillin and esomeprazole in the treatment of Helicobacter Pylori infection.

Publications

Efficacy of reduced-dose regimen of a capsule containing bismuth subcitrate, metronidazole, and tetracycline given with amoxicillin and esomeprazole in the treatment of Helicobacter Pylori infection.

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