Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of helicobacter pylori

A randomized trial

Jyh Ming Liou, Ming Jong Bair, Chieh Chang Chen, Yi Chia Lee, Mei Jyh Chen, Chien Chuan Chen, Cheng Hao Tseng, Yu Jen Fang, Ji Yuh Lee, Tsung Hua Yang, Jiing Chyuan Luo, Jeng Yih Wu, Wen Hsiung Chang, Chun Chao Chang, Chi Yi Chen, Po Yueh Chen, Chia Tung Shun, Wen Feng Hsu, Hsu Wei Hung, Jaw Town Lin & 2 others Chi Yang Chang, Ming Shiang Wu

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Objectives:The efficacy of levofloxacin triple therapy has fallen below 80% in the second-line treatment of Helicobacter pylori (H. pylori). We aimed to assess whether the levofloxacin sequential therapy is more effective than levofloxacin triple therapy in the second-line treatment.Methods:This open-label, randomized, multicenter trial was conducted between 2012 and 2015. H. pylori-infected subjects who failed from clarithromycin-based regimens (N=600) were randomized (1:1) to receive levofloxacin sequential therapy (LS: lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or levofloxacin triple therapy (LT: lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative 13 C-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 prevalence of clarithromycin, levofloxacin, and metronidazole resistance was 60, 17.6, and 36.9%, respectively. The eradication rates of LS and LT were 84.3% (253/300) and 75.3% (226/300), respectively, in the ITT analysis (P=0.006) and 86.3% (253/293) and 78.8% (223/283), respectively, in the PP analysis (P=0.021). The efficacies of both LS and LT were affected by levofloxacin resistance. The secondary resistance of levofloxacin was 66.7 and 73.9% after LS and LT, respectively. The efficacies of LS and LT were not affected by the CYP2C19 polymorphism.Conclusions:Levofloxacin sequential therapy was more effective than levofloxacin triple therapy, and it is recommended in the second-line treatment for H. pylori (Trial registration number: NCT01537055).

Original languageEnglish
Pages (from-to)381-387
Number of pages7
JournalAmerican Journal of Gastroenterology
Volume111
Issue number3
DOIs
Publication statusPublished - Mar 1 2016

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Levofloxacin
Helicobacter pylori
Lansoprazole
Therapeutics
Clarithromycin
Amoxicillin
Metronidazole
Intention to Treat Analysis
Breath Tests
Microbial Drug Resistance
Multicenter Studies
Agar
Urea

ASJC Scopus subject areas

  • Medicine(all)
  • Gastroenterology

Cite this

Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of helicobacter pylori : A randomized trial. / Liou, Jyh Ming; Bair, Ming Jong; Chen, Chieh Chang; Lee, Yi Chia; Chen, Mei Jyh; Chen, Chien Chuan; Tseng, Cheng Hao; Fang, Yu Jen; Lee, Ji Yuh; Yang, Tsung Hua; Luo, Jiing Chyuan; Wu, Jeng Yih; Chang, Wen Hsiung; Chang, Chun Chao; Chen, Chi Yi; Chen, Po Yueh; Shun, Chia Tung; Hsu, Wen Feng; Hung, Hsu Wei; Lin, Jaw Town; Chang, Chi Yang; Wu, Ming Shiang.

In: American Journal of Gastroenterology, Vol. 111, No. 3, 01.03.2016, p. 381-387.

Research output: Contribution to journalArticle

Liou, JM, Bair, MJ, Chen, CC, Lee, YC, Chen, MJ, Chen, CC, Tseng, CH, Fang, YJ, Lee, JY, Yang, TH, Luo, JC, Wu, JY, Chang, WH, Chang, CC, Chen, CY, Chen, PY, Shun, CT, Hsu, WF, Hung, HW, Lin, JT, Chang, CY & Wu, MS 2016, 'Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of helicobacter pylori: A randomized trial', American Journal of Gastroenterology, vol. 111, no. 3, pp. 381-387. https://doi.org/10.1038/ajg.2015.439
Liou, Jyh Ming ; Bair, Ming Jong ; Chen, Chieh Chang ; Lee, Yi Chia ; Chen, Mei Jyh ; Chen, Chien Chuan ; Tseng, Cheng Hao ; Fang, Yu Jen ; Lee, Ji Yuh ; Yang, Tsung Hua ; Luo, Jiing Chyuan ; Wu, Jeng Yih ; Chang, Wen Hsiung ; Chang, Chun Chao ; Chen, Chi Yi ; Chen, Po Yueh ; Shun, Chia Tung ; Hsu, Wen Feng ; Hung, Hsu Wei ; Lin, Jaw Town ; Chang, Chi Yang ; Wu, Ming Shiang. / Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of helicobacter pylori : A randomized trial. In: American Journal of Gastroenterology. 2016 ; Vol. 111, No. 3. pp. 381-387.
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abstract = "Objectives:The efficacy of levofloxacin triple therapy has fallen below 80{\%} in the second-line treatment of Helicobacter pylori (H. pylori). We aimed to assess whether the levofloxacin sequential therapy is more effective than levofloxacin triple therapy in the second-line treatment.Methods:This open-label, randomized, multicenter trial was conducted between 2012 and 2015. H. pylori-infected subjects who failed from clarithromycin-based regimens (N=600) were randomized (1:1) to receive levofloxacin sequential therapy (LS: lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or levofloxacin triple therapy (LT: lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative 13 C-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 prevalence of clarithromycin, levofloxacin, and metronidazole resistance was 60, 17.6, and 36.9{\%}, respectively. The eradication rates of LS and LT were 84.3{\%} (253/300) and 75.3{\%} (226/300), respectively, in the ITT analysis (P=0.006) and 86.3{\%} (253/293) and 78.8{\%} (223/283), respectively, in the PP analysis (P=0.021). The efficacies of both LS and LT were affected by levofloxacin resistance. The secondary resistance of levofloxacin was 66.7 and 73.9{\%} after LS and LT, respectively. The efficacies of LS and LT were not affected by the CYP2C19 polymorphism.Conclusions:Levofloxacin sequential therapy was more effective than levofloxacin triple therapy, and it is recommended in the second-line treatment for H. pylori (Trial registration number: NCT01537055).",
author = "Liou, {Jyh Ming} and Bair, {Ming Jong} and Chen, {Chieh Chang} and Lee, {Yi Chia} and Chen, {Mei Jyh} and Chen, {Chien Chuan} and Tseng, {Cheng Hao} and Fang, {Yu Jen} and Lee, {Ji Yuh} and Yang, {Tsung Hua} and Luo, {Jiing Chyuan} and Wu, {Jeng Yih} and Chang, {Wen Hsiung} and Chang, {Chun Chao} and Chen, {Chi Yi} and Chen, {Po Yueh} and Shun, {Chia Tung} and Hsu, {Wen Feng} and Hung, {Hsu Wei} and Lin, {Jaw Town} and Chang, {Chi Yang} and Wu, {Ming Shiang}",
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T1 - Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of helicobacter pylori

T2 - A randomized trial

AU - Liou, Jyh Ming

AU - Bair, Ming Jong

AU - Chen, Chieh Chang

AU - Lee, Yi Chia

AU - Chen, Mei Jyh

AU - Chen, Chien Chuan

AU - Tseng, Cheng Hao

AU - Fang, Yu Jen

AU - Lee, Ji Yuh

AU - Yang, Tsung Hua

AU - Luo, Jiing Chyuan

AU - Wu, Jeng Yih

AU - Chang, Wen Hsiung

AU - Chang, Chun Chao

AU - Chen, Chi Yi

AU - Chen, Po Yueh

AU - Shun, Chia Tung

AU - Hsu, Wen Feng

AU - Hung, Hsu Wei

AU - Lin, Jaw Town

AU - Chang, Chi Yang

AU - Wu, Ming Shiang

PY - 2016/3/1

Y1 - 2016/3/1

N2 - Objectives:The efficacy of levofloxacin triple therapy has fallen below 80% in the second-line treatment of Helicobacter pylori (H. pylori). We aimed to assess whether the levofloxacin sequential therapy is more effective than levofloxacin triple therapy in the second-line treatment.Methods:This open-label, randomized, multicenter trial was conducted between 2012 and 2015. H. pylori-infected subjects who failed from clarithromycin-based regimens (N=600) were randomized (1:1) to receive levofloxacin sequential therapy (LS: lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or levofloxacin triple therapy (LT: lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative 13 C-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 prevalence of clarithromycin, levofloxacin, and metronidazole resistance was 60, 17.6, and 36.9%, respectively. The eradication rates of LS and LT were 84.3% (253/300) and 75.3% (226/300), respectively, in the ITT analysis (P=0.006) and 86.3% (253/293) and 78.8% (223/283), respectively, in the PP analysis (P=0.021). The efficacies of both LS and LT were affected by levofloxacin resistance. The secondary resistance of levofloxacin was 66.7 and 73.9% after LS and LT, respectively. The efficacies of LS and LT were not affected by the CYP2C19 polymorphism.Conclusions:Levofloxacin sequential therapy was more effective than levofloxacin triple therapy, and it is recommended in the second-line treatment for H. pylori (Trial registration number: NCT01537055).

AB - Objectives:The efficacy of levofloxacin triple therapy has fallen below 80% in the second-line treatment of Helicobacter pylori (H. pylori). We aimed to assess whether the levofloxacin sequential therapy is more effective than levofloxacin triple therapy in the second-line treatment.Methods:This open-label, randomized, multicenter trial was conducted between 2012 and 2015. H. pylori-infected subjects who failed from clarithromycin-based regimens (N=600) were randomized (1:1) to receive levofloxacin sequential therapy (LS: lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, levofloxacin, and metronidazole for another 5 days) or levofloxacin triple therapy (LT: lansoprazole, amoxicillin, and levofloxacin for 10 days). Successful eradication was defined as negative 13 C-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 prevalence of clarithromycin, levofloxacin, and metronidazole resistance was 60, 17.6, and 36.9%, respectively. The eradication rates of LS and LT were 84.3% (253/300) and 75.3% (226/300), respectively, in the ITT analysis (P=0.006) and 86.3% (253/293) and 78.8% (223/283), respectively, in the PP analysis (P=0.021). The efficacies of both LS and LT were affected by levofloxacin resistance. The secondary resistance of levofloxacin was 66.7 and 73.9% after LS and LT, respectively. The efficacies of LS and LT were not affected by the CYP2C19 polymorphism.Conclusions:Levofloxacin sequential therapy was more effective than levofloxacin triple therapy, and it is recommended in the second-line treatment for H. pylori (Trial registration number: NCT01537055).

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