Efficacy of four different moxifloxacin-based triple therapies for first-line H. pylori treatment.
Moxifloxacin has been used in the first-line treatment of Helicobacter pylori infection. The optimal dosage and duration have not been assessed.


OBJECTIVE
To evaluate the effectiveness of moxifloxacin, amoxicillin and esomeprazole in four regimens, in previously untreated patients infected by H. pylori.


METHODS
Patients were randomly assigned to: esomeprazole 20 mg b.i.d., amoxicillin 1g b.i.d., and one of each of the four following dosages of moxifloxacin: moxifloxacin 400 mg b.i.d. for 10 days (EAM800x10), moxifloxacin 400 mg b.i.d. for 7 days (EAM800x7), moxifloxacin 400 mg b.i.d. for 5 days (EAM800x5), moxifloxacin 400 mg o.i.d. for 10 days (EAM400x10). 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 EAM800x10, EAM800x7, EAM800x5, and EAM400x10 respectively. The eradication rate was for Intention-To-Treat (ITT) and Per Protocol (PP) analyses: EAM800x10 group ITT: 90.4%, PP: 94.4%; EAM800x7 group ITT: 80.3%, PP: 86.3%; EAM800x5 group ITT: 71.4%, PP: 75.2%; EAM400x10 group ITT: 80.0%, PP 84.8%. A statistically significant difference was reached between EAM800x10 vs. EAM800x7 (ITT and PP: P<0.05), and between EAM800x10 vs. EAM800x5 (ITT and PP: P<0.01) and vs. EAM400x10 (ITT: P<0.05; PP: P<0.04). Thirty patients treated unsuccessfully with EAM800x5 and EAM400x10 were re-treated with EAM800x10 with an eradication rate of 86.7% (ITT) and 92.2% (PP). Nineteen patients with positive UBT after EAM800x10 and EAM800x7 underwent a second-line rifabutin-based therapy with an eradication rate of 84.2% (ITT and PP).


CONCLUSIONS
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 400mg 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.
Section of Digestive Sciences, Department of Medicine, G.d'Annunzio University, Chieti-Pescara, Italy.
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D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001372:Aza Compounds / Q000008:administration & dosage*; D001944:Breath Tests; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D024841:Fluoroquinolones; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D011804:Quinolines / Q000008:administration & dosage*; D014508:Urea / Q000032:analysis; D055815:Young Adult
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000658:Amoxicillin; D014508:Urea; D064098:Esomeprazole; D000077266:Moxifloxacin