"7, 10 and 14-days rabeprazole-based standard triple therapies for H. pylori eradication: are they still effective? A randomized trial"

Abstract

Background & study aims: Increasing data suggests that the efficiency of standard triple therapies of 7-10-14 days duration has fallen below the threshold for acceptability (80% cure rates in intention to treat analysis). Use of rabeprazole, a PPI less influenced by CYP2C19 gene polymorphisms is reported to lead to improved eradication rates. This study aims to re-examine the effectiveness of 7-10-14 days triple therapies based on rabeprazole in Greek patients.

Patients and methods: 307 patients, from 2 endoscopic centers in Greece, were randomized to receive Rabeprazole 20 mg bid, Clarithromycin 500 mg bid, and Amoxycillin 1gr bid for 7-days, for 10-days or for 14-days. Cure rates were assessed by CLO-test and histology. Clarithromycin sensitivity tests were carried out in the cultured pre-treatment H.pylori strains. The success rates were calculated by both intention-to-treat (ITT) and per protocol (PP) analyses.

Results: The eradication rates according to ITT analyses were 74.5% (95% CI: 66.5-82.9%) for 7-days, 80.6% (95% CI: 73.2-88.2%) for 10-days and 90.2% (95% CI: 84.5-95.9%) for 14-days treatment. PP cure rates were 76% (95% CI: 68.4-85.0%) for 7-days, 83% (95% CI: 76.6-91.0%) for 10-days and 93.9% (95% CI: 86.7-973%) for 14-days treatment. Side effects were generally minor and comparable in all treatment groups.

Conclusions: Both 10- and 14-days rabeprazole-based triple regimens reached eradication rates above the threshold of 80% on an intention to treat basis. In our setting, the current regimen using rabeprazole, amoxicillin and clarithromycin was well tolerated, is still effective and should continue to be recommended as first-line therapy for H. pylori eradication.