Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: A randomised trial

Taiwan Gastrointestinal Disease and Helicobacter Consortium

研究成果: 雜誌貢獻文章

32 引文 (Scopus)

摘要

Objective Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies. Design We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. Results The eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism. Conclusions S10 was not superior to T14 in areas with low clarithromycin resistance. Trial registration number NCT01607918.

原文英語
期刊Gut
DOIs
出版狀態接受/付印 - 九月 3 2015

指紋

S 10
Community Hospital
Helicobacter pylori
Clarithromycin
Lansoprazole
Population
Amoxicillin
Therapeutics
Intention to Treat Analysis
Breath Tests
Pylorus
Metronidazole
Microbial Drug Resistance
Taiwan
Compliance
Multicenter Studies
Agar
Urea

ASJC Scopus subject areas

  • Gastroenterology

引用此文

Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations : A randomised trial. / Taiwan Gastrointestinal Disease and Helicobacter Consortium.

於: Gut, 03.09.2015.

研究成果: 雜誌貢獻文章

@article{87809f81eb8a41b6a9a54d7b452f7161,
title = "Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: A randomised trial",
abstract = "Objective Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies. Design We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection na{\"i}ve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. Results The eradication rates of S10 and T14 were 87.2{\%} (567/650, 95{\%} CI 84.4{\%} to 89.6{\%}) and 85.7{\%} (557/650, 95{\%} CI 82.8{\%} to 88.2{\%}) in the ITT analysis, respectively, and were 91.6{\%} (556/607, 95{\%} CI 89.1{\%} to 93.4{\%}) and 91.0{\%} (548/602, 95{\%} CI 88.5{\%} to 93.1{\%}) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7{\%} and 62.2{\%}, respectively, for S10, and were 91.5{\%} and 44.4{\%}, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism. Conclusions S10 was not superior to T14 in areas with low clarithromycin resistance. Trial registration number NCT01607918.",
author = "{Taiwan Gastrointestinal Disease and Helicobacter Consortium} and Chen, {Chieh Chang} and Chang, {Chi Yang} and Chen, {Mei Jyh} and Chen, {Chien Chuan} and Fang, {Yu Jen} and Lee, {Ji Yuh} and Yang, {Tsung Hua} and Luo, {Jiing Chyuan} and Wu, {Jeng Yih} and Liou, {Tai Cherng} and Chang, {Wen Hsiung} and Hsu, {Yao Chun} and Tseng, {Cheng Hao} and Chang, {Chun Chao} and Bair, {Ming Jong} and Liu, {Tzeng Ying} and Hsieh, {Chun Fu} and Tsao, {Feng Yun} and Shun, {Chia Tung} and Lin, {Jaw Town} and Lee, {Yi Chia} and Wu, {Ming Shiang}",
year = "2015",
month = "9",
day = "3",
doi = "10.1136/gutjnl-2015-310142",
language = "English",
journal = "Gut",
issn = "0017-5749",
publisher = "BMJ Publishing Group",

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TY - JOUR

T1 - Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations

T2 - A randomised trial

AU - Taiwan Gastrointestinal Disease and Helicobacter Consortium

AU - Chen, Chieh Chang

AU - Chang, Chi Yang

AU - Chen, Mei Jyh

AU - Chen, Chien Chuan

AU - Fang, Yu Jen

AU - Lee, Ji Yuh

AU - Yang, Tsung Hua

AU - Luo, Jiing Chyuan

AU - Wu, Jeng Yih

AU - Liou, Tai Cherng

AU - Chang, Wen Hsiung

AU - Hsu, Yao Chun

AU - Tseng, Cheng Hao

AU - Chang, Chun Chao

AU - Bair, Ming Jong

AU - Liu, Tzeng Ying

AU - Hsieh, Chun Fu

AU - Tsao, Feng Yun

AU - Shun, Chia Tung

AU - Lin, Jaw Town

AU - Lee, Yi Chia

AU - Wu, Ming Shiang

PY - 2015/9/3

Y1 - 2015/9/3

N2 - Objective Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies. Design We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. Results The eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism. Conclusions S10 was not superior to T14 in areas with low clarithromycin resistance. Trial registration number NCT01607918.

AB - Objective Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies. Design We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test. Results The eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism. Conclusions S10 was not superior to T14 in areas with low clarithromycin resistance. Trial registration number NCT01607918.

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U2 - 10.1136/gutjnl-2015-310142

DO - 10.1136/gutjnl-2015-310142

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