Tu1064 Esomeprazole Versus Lansoprazole in Triple Therapy for Eradication of Helicobacter pylori in Japan: A Multicenter, Randomized Study by the Osaka Gut Forum

G A A b st ra ct s ethical committee and written informed consent was obtained from all patients. Subjects randomly assigned to three treatment groups for 10 days: Standard triple therapy (STT), Esomeprazole (40 mg b.i.d.) + clarithromycin (500 mg b.id.) + amoxicillin (1,000 mg b.i.d.). Levofloxacin triple therapy (LTT): Esomeprazole (40 mg b.i.d.) + levofloxacin (500 mg once a day) + amoxicillin (1,000 mg b.i.d.) and Levo-Clari triple therapy LCT: Esomeprazole (40 mg b.i.d.) + clarithromycin ((500mg b.i.d.) + levofloxacin (500mg once a day). The allocation was concealed. All were H. pylori positive. Antimicrobial susceptibility was determined by agar dilution and by direct sequencing of PCR products. Post treatment H. pylori status was determined by the 13C-UBT at least 8 weeks after the completion of treatment. The results and analysis of clinical trial was by intention-to-treat (ITT) and per-protocol (PP). Results 240 patients were enrolled between February 2008 and February 2011, 80 patients in each treatment group. ITT results were: STT 71% (95% CI 61% 82%), LTT 75% (95% CI 65% -85%) and LCT 79% (95% CI 70% -91%). PP results were 71%, 75% and 83%, respectively (p = n.s.) The most common mutation resulting in clari resistance was A2143G, and for levofloxacin, mutations D91G, N87K and N871. The relative risk (RR) of failure in relation to specific mutations were: for 23S rRNA in STT 6 and 2.9 for LCT. The (RR) for presence of mutations in both gene gyrA and 23S rRNA in LTT was 14. We performed a logistic regression model to estimate the probability of treatment success. The model variables were associated with the presence of A2143G mutation, N87I, D91G. The probability of treatment success in patients without mutation was 98% compared to 13% for those with mutations in both genes. Adverse events occurred in all three treatment groups and were mild or moderate, with no residual effects. Metallic taste was the most common adverse effect, followed by diarrhea, abdominal pain and nausea. 2 patients required stopping treatment for diarrhea in the LCT group. Conclusion Triple standard therapy and triple therapies containing levofloxacin no provided acceptable cure rates in Bogota because of high rates of clarithromycin and levofloxacin resistance.