Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of helicobacter pylori: A randomized trial
Journal
American Journal of Gastroenterology
Journal Volume
111
Journal Issue
3
Pages
381-387
Date Issued
2016
Author(s)
Bair M.-J.
Tseng C.-H.
Lee J.-Y.
Yang T.-H.
Luo J.-C.
Wu J.-Y.
Chang W.-H.
Chang C.-C.
Chen C.-Y.
Chen P.-Y.
Hung H.-W.
Lin J.-T.
Chang C.-Y.
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). ? 2016 by the American College of Gastroenterology.
SDGs
Other Subjects
amoxicillin; clarithromycin; cytochrome P450 2C19; lansoprazole; levofloxacin; metronidazole; urea c 13; amoxicillin; antiinfective agent; lansoprazole; levofloxacin; metronidazole; abdominal pain; adult; agar dilution; antibiotic resistance; antibiotic therapy; Article; bloating; constipation; controlled study; diarrhea; dizziness; double blind procedure; drug cost; drug efficacy; drug treatment failure; drug withdrawal; eradication therapy; female; genetic polymorphism; headache; Helicobacter infection; human; intention to treat analysis; major clinical study; male; middle aged; multicenter study; nausea; open study; parallel design; prevalence; priority journal; randomized controlled trial; rash; Taiwan; taste disorder; treatment outcome; urea breath test; vomiting; aged; clinical trial; combination drug therapy; drug administration; drug effects; drug monitoring; Helicobacter Infections; Helicobacter pylori; isolation and purification; microbiology; procedures; Stomach Diseases; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Drug Administration Schedule; Drug Monitoring; Drug Therapy, Combination; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Levofloxacin; Male; Metronidazole; Middle Aged; Stomach Diseases; Treatment Outcome
Type
journal article