Esquema secuencial con moxifloxacina de primera línea en el tratamiento del helicobacter pylori: estudio piloto

Abstract

Background: Success in H. pylori eradication with conventional theraies has decreased to unacceptable levels. New schemes of combined treatment are currently needed.

Aim: To quantify the clinical outcomes of a sequential first line therapy, with Esomeprazole, Moxifloxacin, Amoxicilin and Tinidazole for H. pylori eradication.

Methods/patients: Open-label, pilot, single-centre and prospective study. Consecutively will include adults with positive microbiological test for H. pylori and dyspeptic symptoms, Patients will receive a 10-day treatment scheme that consisted of 5 initial days of Esopramezole 40 mg b.d., amoxicillin 1 g b.d.,; days 6 to 10: Esomeprazole 30 mg b.d., Tinidazole 500 mg b.d., and Moxifloxacin 500 mg b.d. Each patient underwent a follow-up Helicobacter pylori stool antigen test, at least 4 weeks after therapy.

Results: 38 of 42 patients completed the study. The eradication rate for H. pylori was 87% (confidence Interval (CI) 95% (75,5 – 98,5%) in the per-protocol analysis (PP) and 81% (CI) 79% (65 – 93%) in the intention-to-treat (ITT) analysis. Adherence to treatment was 95% (40 patients). Among patients who entered to study, 48% presented adverse events, mainly diarrhea and nausea.

Conclusions: Ten-day moxifloxacin-based sequential therapy provide optimal eradication rates with a good compliance and mild and transient side effects