Efficacy of four different moxifloxacin-based triple therapies for first-line H. pylori treatment

Abstract Moxifloxacin has been used in the first-line treatment of Helicobacter pylori infection. The optimal dosage and duration have not been assessed. Aim To evaluate the effectiveness of moxifloxacin, amoxicillin and esomeprazole in four regimens, in previously untreated patients infected by H. pylori. Methods and patients Patients were randomly assigned to: esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and one of each of the four following dosages of moxifloxacin: moxifloxacin 400 mg b.i.d. for 10 days (EAM800 × 10), moxifloxacin 400 mg b.i.d. for 7 days (EAM800 × 7), moxifloxacin 400 mg b.i.d. for 5 days (EAM800 × 5), moxifloxacin 400 mg o.i.d. for 10 days (EAM400 × 10). Eradication was assessed by the Urea Breath Test (UBT) 2 months following the end of therapy. Results Ninety-four, 102, 92 and 105 patients were recruited in EAM800 × 10, EAM800 × 7, EAM800 × 5, and EAM400 × 10 respectively. The eradication rate was for Intention-To-Treat (ITT) and Per Protocol (PP) analyses: EAM800 × 10 group ITT: 90.4%, PP: 94.4%; EAM800 × 7 group ITT: 80.3%, PP: 86.3%; EAM800 × 5 group ITT: 71.4%, PP: 75.2%; EAM400 × 10 group ITT: 80.0%, PP 84.8%. A statistically significant difference was reached between EAM800 × 10 vs. EAM800 × 7 (ITT and PP: P < 0.05), and between EAM800 × 10 vs. EAM800 × 5 (ITT and PP: P < 0.01) and vs. EAM400 × 10 (ITT: P < 0.05; PP: P < 0.04). Thirty patients treated unsuccessfully with EAM800 × 5 and EAM400 × 10 were re-treated with EAM800 × 10 with an eradication rate of 86.7% (ITT) and 92.2% (PP). Nineteen patients with positive UBT after EAM800 × 10 and EAM800 × 7 underwent a second-line rifabutin-based therapy with an eradication rate of 84.2% (ITT and PP). Conclusion A triple therapy with 800 mg of moxifloxacin a day for 10 days is more effective than the same treatment for 5 or 7 days and a treatment with 400 mg of moxifloxacin a day for 10 days for the first-line eradication of H. pylori infection. The high cost of moxifloxacin-based treatment however, may limit its wide use as first-line treatment of H. pylori infection.