4-day triple therapy with rabeprazole, amoxicillin and clarithromycin in the eradication of Helicobacter pylori in patients with peptic ulcer disease

Summary

Background: It is well established that a 7-day triple therapy achieves eradication rates of Helicobacter pylori between 90 % and 95 %. Due to a lack of highly effective short-term eradication studies the aim of the present pilot study was to investigate the effect of a 4-day triple therapy with the new proton pump inhibitor rabeprazole (20 mg b. i. d.) in combination with clarithromycin (500 mg b. i. d.) and amoxicillin (1 g b. i. d.) without acid-suppressive pre-treatment in patients with H. pylori-related peptic ulcer disease.

Methods: 20 patients (11 men, 9 women) with endoscopically diagnosed peptic ulcers (gastric ulcer: n = 5; duodenal ulcer: n = 9; combined gastric and duodenal ulcer: n = 2, gastric or duodenal ulcer scars: n = 4) and H. pylori infection were consecutively recruited. The Helicobacter pylori status was assessed by means of histology, CLO (urea-) test and C¹³-urea breath test (C¹³-UBT) at entry. Treatment success was determined by C¹³-UBT 35-42 days after end of treatment.

Results: In 18 out of the 20 patients (90 %) [77-100 %, 95 %-CI] a negative test result was found in C¹³-UBT 35-42 days after treatment. The 2 patients who remained H. pylori-positive had a duodenal ulcer.

Conclusion: A 4-day triple therapy of rabeprazole in combination with clarithromycin and amoxicillin seems to be highly effective in eradicating H. pylori and well tolerated in patients with gastric and duodenal ulcer disease. The achieved eradication rate of 90 % is comparable with the established 7-day triple therapy regimens. On the basis of these results and considering costs, side effects and compliance a large number of patients should be enrolled in a confirmatory 4-day eradication trial.

4-tägige Eradikationstherapie mit Rabeprazol, Amoxicillin und Clarithromycin bei Patienten mit peptischer Ulkuserkrankung und Helicobacter-pylori-Infektion - eine Pilotstudie

Hintergrund/Ziel: Aufgrund der nur spärlichen Datenlage zur Kurzzeiteradikation war es das Ziel dieser Pilotstudie, die Wirksamkeit einer 4-tägigen Eradikationstherapie mit dem neuen Protonenpumpeninhibitor Rabeprazol (2 × 20 mg/d) in Kombination mit Clarithromycin (2 × 500 mg/d) und Amoxicillin (2 × 1 g/d) an 20 Patienten mit Helicobacter pylori-assoziierten peptischen Ulzera zu untersuchen. Methoden: 20 Patienten (11 Männer, 9 Frauen) mit endoskopisch gesichertem peptischem Ulkus (Ulcus ventriculi: n = 5, Ulcus duodeni: n = 9, Ulcus ventriculi et duodeni: n = 2, Ulkunisnarben: n = 4) und Helicobacter-pylori-Infektion wurden in die Studie eingeschlossen. Die Infektion Mit Helicobacter pylori wurde histologisch durch den Urease-Schnelltest (CLO-Test) und im ¹³C-Harnstoff-Atemtest bei Studienbeginn gesichert. Der Behandlungserfolg wurde im ¹³C-Harnstoff-Atemtest 35-42 Tage nach Behandlung gemessen. Ergebnis: Von den 20 Patienten hatten 18 Patienten (90 %) ein negatives Ergebnis im ¹³C-Harnstoff-Atemtest nach Eradikationstherapie. Die beiden Patienten mit positivem Atemtest hatten bei Einschluss in die Studie ein Ulcus duodeni. Die Therapie wurde allgemein gut vertragen, schwer wiegende unerwünschte Ereignisse traten während der Studiendauer nicht auf. Schlussfolgerung: Eine 4-tägige Kurzzeit-Tripeltherapie mit Rabeprazol (2 × 20 mg/d) in Kombination mit Clarithromycin (2 × 500 mg/d) und Amoxicillin (2 × 1 g/d) ist mit einer Erfolgsrate von 90 % hoch wirksam in der Eradikation von Helicobacter pylori bei Patienten mit peptischer Ulkuserkrankung und mit den Ergebnisse der etablierten 7-tägigen Tripeltherapien vergleichbar. Die Ereignisse dieser Pilotstudie sollten zu einer größeren, kontrollierten Multizenterstudie auffordern, um bei Bestätigung der vorliegenden Ergebnisse die Behandlungskosten einer Eradikationstherapie zu erniedrigen und die Patientencompliance zu erhöhen.

Key words

Eradication - Triple Therapy - Rabeprazole - Short-term - Helicobacter pylori

Schlüsselwörter

Eradikation - Tripeltherapie - Kurzzeit - Rabeprazol - Helicobacter pylori

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