The modified sequential treatment regimen containing levofloxacin for Helicobacter pylori eradication in Turkey.

BACKGROUND: Eradication rates of Helicobacter pylori have declined to unacceptable levels in recent years. New and effective treatment options are warranted both as a first and second line treatment. AIM: To test an effectiveness of modified sequential therapy with levofloxacin for H. pylori eradication in Turkey. MATERIAL AND METHODS: Helicobacter pylori infected dyspeptic patients were included to the study. Subjects were treated with modified sequential therapy consisting of rabeprazole 20 mg b.i.d. and amoxicillin 1 g b.i.d., for 7 days followed by rabeprazole 20 mg b.i.d, levofloxacin 500 mg q.d. and metronidazole 500 mg b.i.d for the remaining 7 days. RESULTS: Sixty-three treatment naive patients and 37 previous treatment failures were enrolled to the study (59 F, 41 M, age: 21-80 years). There was five drop out. Helicobacter pylori eradication was achieved in 80 patients, intention-to-treat (ITT): 80% (95% CI: 71-87%) and per-protocol (PP): 84.2% (95% CI: 75-91%), totally. In treatment naive patients ITT and PP eradication rates were 82.5% (95% CI: 71-91%), and 86.7% (95% CI: 75-94%), respectively. As a second line treatment eradication was successful in ITT 75.7%.(95% CI: 59-88%), and PP 80% (95% CI: 63-92%).Mild side effects were reported by 8 patients (8.4%). CONCLUSIONS: Sequential therapy using "rabeprazole and amoxicillin 7 days followed by rabeprazole, metronidazole and levofloxacin for 7 days" is a new regimen with acceptable eradication rates in naïve patients in Turkey. Further modifications in the dose or duration of this new sequential therapy might increase its effectiveness as both first and second line treatment.