title: Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial.
abstract: OBJECTIVE
  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 (
  
  
  BACKGROUND
  NCT01537055).
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Jyh-Ming
authors.initials: JM
authors.lastname: Liou
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taitung, Taiwan.|Department of Nursing, Meiho University, Pingtung, Taiwan.
authors.forename: Ming-Jong
authors.initials: MJ
authors.lastname: Bair
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Chieh-Chang
authors.initials: CC
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Yi-Chia
authors.initials: YC
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Mei-Jyh
authors.initials: MJ
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Chien-Chuan
authors.initials: CC
authors.lastname: Chen
authors.affiliation: Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan.
authors.forename: Cheng-Hao
authors.initials: CH
authors.lastname: Tseng
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Yun-Lin, Taiwan.
authors.forename: Yu-Jen
authors.initials: YJ
authors.lastname: Fang
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Yun-Lin, Taiwan.
authors.forename: Ji-Yuh
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Yun-Lin, Taiwan.
authors.forename: Tsung-Hua
authors.initials: TH
authors.lastname: Yang
authors.affiliation: Department of Medicine, National Yang-Ming University, School of Medicine and Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Jiing-Chyuan
authors.initials: JC
authors.lastname: Luo
authors.affiliation: Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung County, Taiwan.
authors.forename: Jeng-Yih
authors.initials: JY
authors.lastname: Wu
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
authors.forename: Wen-Hsiung
authors.initials: WH
authors.lastname: Chang
authors.affiliation: Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
authors.forename: Chun-Chao
authors.initials: CC
authors.lastname: Chang
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chia-Yi Christian Hospital, Chiayi, Taiwan.
authors.forename: Chi-Yi
authors.initials: CY
authors.lastname: Chen
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chia-Yi Christian Hospital, Chiayi, Taiwan.
authors.forename: Po-Yueh
authors.initials: PY
authors.lastname: Chen
authors.affiliation: Department of Pathology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Chia-Tung
authors.initials: CT
authors.lastname: Shun
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.
authors.forename: Wen-Feng
authors.initials: WF
authors.lastname: Hsu
authors.affiliation: Department of Molecular Medicine, Taipei Institute of Pathology, Taipei, Taiwan.
authors.forename: Hsu-Wei
authors.initials: HW
authors.lastname: Hung
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.|School of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.
authors.forename: Jaw-Town
authors.initials: JT
authors.lastname: Lin
authors.affiliation: Department of Nursing, Meiho University, Pingtung, Taiwan.
authors.forename: Chi-Yang
authors.initials: CY
authors.lastname: Chang
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Ming-Shiang
authors.initials: MS
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D064747:Lansoprazole / Q000008:administration & dosage / Q000009:adverse effects; D064704:Levofloxacin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D013272:Stomach Diseases / Q000188:drug therapy / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D064747:Lansoprazole; D008795:Metronidazole; D064704:Levofloxacin; D000658:Amoxicillin
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