Rifabutin-based 10-day and 14-day triple therapy as a third-line and fourth-line regimen for Helicobacter pylori eradication: A pilot study

Hideki Mori, Hidekazu Suzuki, Juntaro Matsuzaki, Hitoshi Tsugawa, Seiichiro Fukuhara, Sawako Miyoshi, Kenro Hirata, Takashi Seino, Misako Matsushita, Toshihiro Nishizawa, Tatsuhiro Masaoka, Takanori Kanai

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Background and aim: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutin-based triple therapy as a third- or fourth-line rescue therapy. Methods: Patients who failed first- and second-line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10-day or 14-day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80% of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. Results: Twelve patients were assigned to the 10-day group, and 17, to the 14-day group. Intention-to-treat and per-protocol analyses of eradication rates were 83.3% and 81.8% for the 10-day group and 94.1% and 91.7% for the 14-day group, respectively. All patients with rpoB mutation-positive strains (n = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3% and 29.3% of patients in the 10-day and 14-day groups, respectively. Conclusion: Both the 10-day and 14-day therapies were effective as rescue regimens. In particular, the 14-day therapy resulted in successful eradication in over 90% of patients, but the 10-day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.

Original languageEnglish
Pages (from-to)380-387
Number of pages8
JournalUnited European Gastroenterology Journal
Volume4
Issue number3
DOIs
Publication statusPublished - 2016 Jun 1

Fingerprint

Rifabutin
Helicobacter pylori
Therapeutics
Amoxicillin
Rifamycins
Esomeprazole
Mutation
Breath Tests
R Factors
Microbial Sensitivity Tests
Urea
Stomach
Prospective Studies

Keywords

  • amoxicillin
  • Rifabutin
  • rpoB

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

Rifabutin-based 10-day and 14-day triple therapy as a third-line and fourth-line regimen for Helicobacter pylori eradication : A pilot study. / Mori, Hideki; Suzuki, Hidekazu; Matsuzaki, Juntaro; Tsugawa, Hitoshi; Fukuhara, Seiichiro; Miyoshi, Sawako; Hirata, Kenro; Seino, Takashi; Matsushita, Misako; Nishizawa, Toshihiro; Masaoka, Tatsuhiro; Kanai, Takanori.

In: United European Gastroenterology Journal, Vol. 4, No. 3, 01.06.2016, p. 380-387.

Research output: Contribution to journalArticle

@article{0d36617f32094e30a66601d9fdbdc878,
title = "Rifabutin-based 10-day and 14-day triple therapy as a third-line and fourth-line regimen for Helicobacter pylori eradication: A pilot study",
abstract = "Background and aim: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutin-based triple therapy as a third- or fourth-line rescue therapy. Methods: Patients who failed first- and second-line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10-day or 14-day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80{\%} of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. Results: Twelve patients were assigned to the 10-day group, and 17, to the 14-day group. Intention-to-treat and per-protocol analyses of eradication rates were 83.3{\%} and 81.8{\%} for the 10-day group and 94.1{\%} and 91.7{\%} for the 14-day group, respectively. All patients with rpoB mutation-positive strains (n = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3{\%} and 29.3{\%} of patients in the 10-day and 14-day groups, respectively. Conclusion: Both the 10-day and 14-day therapies were effective as rescue regimens. In particular, the 14-day therapy resulted in successful eradication in over 90{\%} of patients, but the 10-day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.",
keywords = "amoxicillin, Rifabutin, rpoB",
author = "Hideki Mori and Hidekazu Suzuki and Juntaro Matsuzaki and Hitoshi Tsugawa and Seiichiro Fukuhara and Sawako Miyoshi and Kenro Hirata and Takashi Seino and Misako Matsushita and Toshihiro Nishizawa and Tatsuhiro Masaoka and Takanori Kanai",
year = "2016",
month = "6",
day = "1",
doi = "10.1177/2050640615618043",
language = "English",
volume = "4",
pages = "380--387",
journal = "United European Gastroenterology Journal",
issn = "2050-6406",
publisher = "SAGE Publications Inc.",
number = "3",

}

TY - JOUR

T1 - Rifabutin-based 10-day and 14-day triple therapy as a third-line and fourth-line regimen for Helicobacter pylori eradication

T2 - A pilot study

AU - Mori, Hideki

AU - Suzuki, Hidekazu

AU - Matsuzaki, Juntaro

AU - Tsugawa, Hitoshi

AU - Fukuhara, Seiichiro

AU - Miyoshi, Sawako

AU - Hirata, Kenro

AU - Seino, Takashi

AU - Matsushita, Misako

AU - Nishizawa, Toshihiro

AU - Masaoka, Tatsuhiro

AU - Kanai, Takanori

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Background and aim: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutin-based triple therapy as a third- or fourth-line rescue therapy. Methods: Patients who failed first- and second-line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10-day or 14-day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80% of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. Results: Twelve patients were assigned to the 10-day group, and 17, to the 14-day group. Intention-to-treat and per-protocol analyses of eradication rates were 83.3% and 81.8% for the 10-day group and 94.1% and 91.7% for the 14-day group, respectively. All patients with rpoB mutation-positive strains (n = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3% and 29.3% of patients in the 10-day and 14-day groups, respectively. Conclusion: Both the 10-day and 14-day therapies were effective as rescue regimens. In particular, the 14-day therapy resulted in successful eradication in over 90% of patients, but the 10-day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.

AB - Background and aim: This prospective randomized study was designed to assess the efficacy of 10-day and 14-day rifabutin-based triple therapy as a third- or fourth-line rescue therapy. Methods: Patients who failed first- and second-line eradication therapy were enrolled. H. pylori was isolated from gastric biopsy specimens and the rpoB mutation status, a factor of resistance to rifamycins, and minimum inhibitory concentrations (MICs) of rifabutin and amoxicillin were determined. Enrolled patients were randomly assigned to receive 10-day or 14-day eradication therapy with esomeprazole (20 mg, 4 times a day (q.i.d.)), amoxicillin (500 mg, q.i.d.), and rifabutin (300 mg, once a day (q.d.s.)). Poor compliance was defined as intake of <80% of study drugs. Successful H. pylori eradication was confirmed using a [13C] urea breath test or a stool antigen test, 12 weeks after the end of therapy. Results: Twelve patients were assigned to the 10-day group, and 17, to the 14-day group. Intention-to-treat and per-protocol analyses of eradication rates were 83.3% and 81.8% for the 10-day group and 94.1% and 91.7% for the 14-day group, respectively. All patients with rpoB mutation-positive strains (n = 3) showed successful eradication, irrespective of the regimen received. Therapy was stopped due to adverse events in 8.3% and 29.3% of patients in the 10-day and 14-day groups, respectively. Conclusion: Both the 10-day and 14-day therapies were effective as rescue regimens. In particular, the 14-day therapy resulted in successful eradication in over 90% of patients, but the 10-day treatment may be enough to obtain a successful eradication rate, considering the tolerability of therapy.

KW - amoxicillin

KW - Rifabutin

KW - rpoB

UR - http://www.scopus.com/inward/record.url?scp=85006230739&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85006230739&partnerID=8YFLogxK

U2 - 10.1177/2050640615618043

DO - 10.1177/2050640615618043

M3 - Article

AN - SCOPUS:85006230739

VL - 4

SP - 380

EP - 387

JO - United European Gastroenterology Journal

JF - United European Gastroenterology Journal

SN - 2050-6406

IS - 3

ER -