title: Randomized trial on 14 versus 7 days of esomeprazole, moxifloxacin, and amoxicillin for second-line or rescue treatment of Helicobacter pylori infection.
abstract: BACKGROUND
  Triple therapy with a proton pump inhibitor, moxifloxacin, and amoxicillin has been proven effective in first-line treatment of Helicobacter pylori infection.
  
  
  OBJECTIVE
  To explore 1, the value of triple therapy with esomeprazole, moxifloxacin, and amoxicillin in second-line or rescue treatment of Caucasian patients and 2, the impact of treatment duration on eradication success.
  
  
  METHODS
  H. pylori-infected patients with at least one previous treatment failure were randomized to oral esomeprazole 20 mg b.i.d., moxifloxacin 400 mg o.d., and amoxicillin 1000 mg b.i.d. for either 7 (EMA-7) or 14 days (EMA-14). Eradication was confirmed by 13C urea breath test. Antimicrobial susceptibility testing was performed in all patients at baseline and in patients who failed treatment.
  
  
  RESULTS
  Eighty patients were randomized, and 60% had ≥ 2 previous treatment failures. Pretreatment resistance against clarithromycin and metronidazole was found in 70.5 and 61.5% of cases, respectively. The intention-to-treat eradication rate was significantly higher after EMA-14 compared with EMA-7 (95.0 vs 78.9%, p = .036). No independent risk factor for treatment failure could be identified. There were no serious adverse events. Five of the EMA-14 patients (12.5%) compared with none of the EMA-7 patients discontinued prematurely because of adverse events (p = .031). Post-treatment resistance against moxifloxacin was found in one of seven patients with isolated organisms (14.3%).
  
  
  CONCLUSIONS
  Second-line/rescue H. pylori eradication therapy with esomeprazole, moxifloxacin, and amoxicillin is very effective and well tolerated. Fourteen days of treatment significantly increase the eradication rate but also the rate of adverse events.
authors: Center for Digestive Diseases, Cooperation of Internal Medicine, Hamburg, Germany. prof.miehlke@mdz-hamburg.de
authors: Stephan
authors: S
authors: Miehlke
authors: Susanne
authors: S
authors: Krasz
authors: Wulf
authors: W
authors: Schneider-Brachert
authors: Eberhard
authors: E
authors: Kuhlisch
authors: Marco
authors: M
authors: Berning
authors: Ahmed
authors: A
authors: Madisch
authors: Martin W
authors: MW
authors: Laass
authors: Michael
authors: M
authors: Neumeyer
authors: Claus
authors: C
authors: Jebens
authors: Christian
authors: C
authors: Zekorn
authors: Holger
authors: H
authors: Knoth
authors: Michael
authors: M
authors: Vieth
authors: Manfred
authors: M
authors: Stolte
authors: Norbert
authors: N
authors: Lehn
authors: Andrea
authors: A
authors: Morgner
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D024841:Fluoroquinolones; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D000077266:Moxifloxacin; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis; D044465:White People
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000658:Amoxicillin; D014508:Urea; D064098:Esomeprazole; D000077266:Moxifloxacin