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High eradication rate of H. pylori with moxifloxacin-based treatment: a randomized controlled trial

Hohe Eradikationsrate von H. pylori mit Moxifloxacin-basierter Therapie: eine randomisierte kontrollierte Studie

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Zusammenfassung

EINLEITUNG: In der klinischen Praxis stellt die Eradikation von Helikobacter pylori (HP) noch immer eine problematische Therapie dar. Ziel ist, eine hohe Eradikationsrate zu einem niedrigen Preis zu erzielen; die derzeitigen Behandlungsmöglichkeiten geben uns dazu die Möglichkeit. Kürzlich veröffentlichte Resultate mit einer auf Moxifloxacin basierten Therapie zeigten eine niedrige Resistenzrate und eine gute Kompliance. Die vorliegende Studie untersucht die Wirksamkeit des Einsatzes von Moxifloxacin im Rahmen einer Triple-Therapie zur Eradikation von HP. ZIEL UND METHODEN: Ziel unserer Studie war es, die Wirksamkeit einer einwöchigen Moxifloxacin-basierten HP-Eradikationstherapie mit der Standard-Therapie zur vergleichen. 277 HP-positive Patienten mit einer Dyspepsie ohne Ulcus wurden in 4 Gruppen randomisiert: MML Gruppe: Moxifloxacin 400 mg/Tag, Metronidazol 2 × 400 mg/Tag, Lansoprazol 30 mg 2 × tgl; MAL Gruppe: Moxifloxacin 400 mg/Tag, Amoxicillin 1 g 2 × tgl, Lansoprazol 30 mg 2 × tgl; CML Gruppe: Clarithromycin 500 mg 2 × tgl., Metronidazol 400 mg 2 × tgl, Lansoprazol 30 mg 2 × tgl; und die CAL Gruppe: Clarithromycin 500 mg 2 × tgl, Amoxicillin 1 g 2 × tgl, Lansoprazol 30 mg 2 × tgl. Zur Erfassung der Prävalenz des HP wurden die Patienten mittels dem CLO Test untersucht. Außerdem wurde vor der Randomisierung und 4–6 Wochen nach Ende der Therapie gastroskopisch eine Histologie gewonnen und eine Kultur angelegt. Die bakterielle Empfindlichkeit auf Clarithromycin und Moxifloxacin wurden durch den E-Test bestimmt. ERGEBNISSE: 265 Patienten (95,6%) vollendeten die Studie. Die HP-Eradikationsrate war entsprechend der ITT und der PP Analysen in der MML Gruppe 93,5% (58/62) und 96,7% (58/60); in der MAL Gruppe 86,4% (57/66) und 90,5% (57/63), in der CML Gruppe 70,4% (50/71) und 75,8% (50/66) sowie in der CAL Gruppe 78,2% (61/78) sowie 80,2% (61/76). Die Behandlungsprotokolle mit Moxifloxacin waren waren sowohl in der ITT als auch in der PP Analyse signifikant erfolgreicher als die Clarithromycin-basierten Therapieregimes. Von den 238 Patienten (86% der gesamten Studiengruppe) waren 10,8% primär gegen Clarithromycin und 5,9% primär gegen Moxifloxacin resistent. Die Eradikation der Moxifloxacin-sensitiven/resistenten Keimstämme lag bei 98,1/75% für das MML (p < 0,01) und bei 99,1/66,7% für das MAL Regime (p = n.s.), verglichen mit dem Erfolg bei Moxifloxacin-sensitiven Stämmen von 98,1/91,1% (p < 0,05) bzw. Moxifloxacin-resistenten von 75/66,7% (p = n.s.) für die MML und MAL Gruppen. Die Behandlungsprotokolle mit Clarithromycin unterschieden sich bezüglich ihrer Wirksamkeit, sensitive oder resistente Keimstämme zu eradizieren, nicht signifikant. SCHLUSSFOLGERUNG: Triple-Therapien mit Moxifloxacin zeigten höhere Eradikationsraten mit weniger Nebenwirkungen als die bisherige Standardtherapie, sowie eine gute Kompliance. Außerdem macht die zunehmende Prävalenz der Resistenz gegenüber Clarithromycin Moxifloxacin-basierte Therapieprotokolle wahrscheinlich zu einer wirksamen und sicheren Option zur Behandlung einer Infektion mit HP.

Summary

INTRODUCTION: Eradication of Helicobacter pylori remains a problematic treatment issue in clinical practice. The intention is to find a treatment that achieves a high rate of eradication at a low price and treatment options that are now used give us the opportunity to achieve this goal. Recently published results showing a low rate of resistance and better compliance with moxifloxacin-based treatment regimens indicate the need to investigate its efficacy in H. pylori eradication. This study is based on proving the efficacy of moxifloxacin in H. pylori eradication within the triple therapy. AIMS AND METHODS: The aim of the study was to compare the efficacy of one week of moxifloxacin-based treatment with the standard treatment for H. pylori eradication. Patients with H. pylori infection and non-ulcer dyspepsia (n = 277) were randomly divided into four groups to receive: moxifloxacin 400 mg/d, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (MML group); moxifloxacin 400 mg/d, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (MAL group); clarithromycin 500 mg twice daily, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (CML group); clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (CAL group). The patients were assessed for prevalence of H. pylori using the CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomization and 4–6 weeks after completion of treatment. Bacterial sensitivity to clarithromycin and moxifloxacin was determined with the E-test. RESULTS: 265 (95.6%) patients completed the study forming the basis for PP analysis. Eradication rates of H. pylori in ITT and in PP analyses were: in the MML group 93.5% (58/62) and 96.7% (58/60), respectively; in the MAL group 86.4% (57/66) and 90.5% (57/63); in the CML group 70.4% (50/71) and 75.8% (50/66); and in the CAL group 78.2% (61/78) and 80.2% (61/76). Moxifloxacin treatment protocols were significantly more effective on both ITT and PP analyses than the clarithromycin based protocols with only one exception (MAL vs. CAL on ITT analysis). Among 238 patients (86% of the entire study group), strains showing primary resistance to clarithromycin were found in 10.8% and to moxifloxacin in 5.9%. Eradication of moxifloxacin sensitive/resistant strains was 98.1%/75% for MML (p < 0.01) and 91.1%/66.7% for MAL (p = n.s.); comparison of eradication of sensitive strains in MML and MAL regimens was 98.1%/91.1% (p < 0.05), and for resistant strains 75%/66.7% (p = n.s.). CML and CAL protocols did not differ in efficacy of eradication of clarithromycin sensitive or resistant strains. CONCLUSION: Moxifloxacin-based triple therapies showed higher eradication rates with few side effects and good drug compliance when compared with standard H. pylori treatments. Moreover, the increased prevalence of clarithromycin resistance suggests that moxifloxacin-based regimens could be safe and effective options in treatment of H. pylori infection.

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Authors and Affiliations

  1. Department of Gastroenterology, Internal Medicine Clinic, General Hospital 'Sveti Duh', Zagreb, Croatia

    Petra Bago, Marjan Rožankovic, Marinko Marušić & Josip Bago

  2. Department of Gastroenterology, Internal Medicine Clinic, University Hospital, Osijek, Croatia

    Aleksandar Vcev

  3. Department of Gastroenterology, Internal Medicine Clinic, University Hospital 'Mostar', Mostar, Bosnia and Herzegovina

    Monika Tomic

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  1. Petra Bago
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  2. Aleksandar Vcev
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  3. Monika Tomic
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  4. Marjan Rožankovic
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  5. Marinko Marušić
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  6. Josip Bago
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Correspondence to Josip Bago.

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Bago, P., Vcev, A., Tomic, M. et al. High eradication rate of H. pylori with moxifloxacin-based treatment: a randomized controlled trial. Wien Klin Wochenschr 119, 372–378 (2007). https://doi.org/10.1007/s00508-007-0807-2

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  • DOI: https://doi.org/10.1007/s00508-007-0807-2

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