Randomized trial on 14 versus 7 days of esomeprazole, moxifloxacin, and amoxicillin for second-line or rescue treatment of Helicobacter pylori infection
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Randomized trial on 14 versus 7 days of esomeprazole, moxifloxacin, and amoxicillin for second-line or rescue treatment of Helicobacter pylori infection. / Miehlke, Stephan; Krasz, Susanne; Schneider-Brachert, Wulf; Kuhlisch, Eberhard; Berning, Marco; Madisch, Ahmed; Laass, Martin W; Neumeyer, Michael; Jebens, Claus; Zekorn, Christian; Knoth, Holger; Vieth, Michael; Stolte, Manfred; Lehn, Norbert; Morgner, Andrea.
In: HELICOBACTER, Vol. 16, No. 6, 12.2011, p. 420-6.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Randomized trial on 14 versus 7 days of esomeprazole, moxifloxacin, and amoxicillin for second-line or rescue treatment of Helicobacter pylori infection
AU - Miehlke, Stephan
AU - Krasz, Susanne
AU - Schneider-Brachert, Wulf
AU - Kuhlisch, Eberhard
AU - Berning, Marco
AU - Madisch, Ahmed
AU - Laass, Martin W
AU - Neumeyer, Michael
AU - Jebens, Claus
AU - Zekorn, Christian
AU - Knoth, Holger
AU - Vieth, Michael
AU - Stolte, Manfred
AU - Lehn, Norbert
AU - Morgner, Andrea
N1 - © 2011 Blackwell Publishing Ltd.
PY - 2011/12
Y1 - 2011/12
N2 - BACKGROUND: Triple therapy with a proton pump inhibitor, moxifloxacin, and amoxicillin has been proven effective in first-line treatment of Helicobacter pylori infection.AIM: 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%).CONCLUSION: 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.
AB - BACKGROUND: Triple therapy with a proton pump inhibitor, moxifloxacin, and amoxicillin has been proven effective in first-line treatment of Helicobacter pylori infection.AIM: 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%).CONCLUSION: 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.
KW - Adult
KW - Aged
KW - Amoxicillin
KW - Anti-Bacterial Agents
KW - Anti-Ulcer Agents
KW - Aza Compounds
KW - Breath Tests
KW - Drug Therapy, Combination
KW - Esomeprazole
KW - European Continental Ancestry Group
KW - Female
KW - Fluoroquinolones
KW - Helicobacter Infections
KW - Helicobacter pylori
KW - Humans
KW - Male
KW - Microbial Sensitivity Tests
KW - Middle Aged
KW - Quinolines
KW - Salvage Therapy
KW - Time Factors
KW - Treatment Outcome
KW - Urea
KW - Journal Article
KW - Randomized Controlled Trial
KW - Research Support, Non-U.S. Gov't
U2 - 10.1111/j.1523-5378.2011.00867.x
DO - 10.1111/j.1523-5378.2011.00867.x
M3 - SCORING: Journal article
C2 - 22059392
VL - 16
SP - 420
EP - 426
JO - HELICOBACTER
JF - HELICOBACTER
SN - 1083-4389
IS - 6
ER -