Rabeprazole, amoxycillin and low- or high-dose clarithromycin for cure of Helicobacter pylori infection

Background: Rabeprazole sodium is a proton pump inhibitor. Aim: To evaluate the efficacy and safety of 1-week. triple therapy with rab eprazole, amoxycillin and clarithromycin for the eradication of Helicobacte r pylori. Methods: A total of 100 subjects with H. pylori were randomly divided into two groups of 1-week. triple therapy with rabeprazole 10 mg b.d., amoxycill in 750 mg b.d, and either clarithromycin 200 mg b,d. (RAC400, n=50) or clar ithromycin 400 mg b.d. (RAC800, n = 50), Endoscopic examination with four b iopsies (two specimens from the antrum and two from the gastric body) was p erformed. The status of H. pylori infection was determined using culture an d histology (Giemsa stain) of the biopsy specimens. Sensitivity to clarithr omycin was determined using the E-test: MIC > 8 g/mL, was considered to be resistant, whereas MIC < 2 g/mL was considered to be sensitive. Cure was de fined as no evidence of H. pylori infection 1 month after completion of tre atment. Results: There were no significant differences in the clinical characterist ics of the two groups. Eradication rates (intention-to-treat and per protoc ol, respectively) were: RAC400: 86% (95% CI: 76-95%) and 89% (95% CI: 80-97 %): RAC800: 94% (95% CI: 87-100%) and 97% (95% CI: 94-100%), There was no s ignificant difference between the eradication rates of either regimen. Thre e subjects with failed eradication in the RAC400 group were all infected wi th a clarithromycin-resistant strain before beginning the therapy. Haemorrh agic colitis was the only severe adverse event, which was observed in one p atient in the RAC800 group. Conclusion: One-week triple therapy with rabeprazole, amoxycillin and low-d ose clarithromycin is effective for the eradication of H. pylori infection.