Summary and Introduction
Background: The efficacy of levofloxacin-based quadruple therapy in resistant Helicobacter pylori infection is not known.
Aim: To test the efficacy of levofloxacin-based quadruple therapy and traditional quadruple therapy in resistant H. pylori infection.
Methods: One hundred and two patients with resistant H. pylori infection were randomized to 1 week of either EBAL (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., amoxicillin 1 g b.d. and levofloxacin 500 mg b.d.) or EBMT (esomeprazole 40 mg b.d., bismuth subcitrate 240 mg b.d., metronidazole 400 mg t.d.s. and tetracycline 500 mg q.d.s.). 13C-urea breath test was performed at week 12 to assess post-treatment H. pylori status.
Results: In intention-to-treat analysis H. pylori eradication was achieved in 37 of 51 (73%) subjects in EBAL and 45 of 51 (88%) subjects in EBMT groups, respectively (P = 0.046). Per-protocol eradication rates of EBAL and EMBT groups were 78% and 94%, respectively (P = 0.030). The intention-to-treat eradication rate was statistically lower for EBAL than EMBT (56% vs. 90%, P = 0.013) among those who had failed more than one course of eradication therapy. Previous levofloxacin triple therapy did not affect the efficacy of either protocol significantly.
Conclusions: Levofloxacin-based quadruple therapy was inferior to traditional quadruple therapy for resistant H. pylori infection.
Warren and Marshall first discovered Helicobacter pylori in 1982. The importance of H. pylori infection in the pathogenesis of peptic ulcer disease, gastritis and gastric malignancy are well established. Antibiotics are important ingredients in all the H. pylori eradication regimens. However, antibiotic resistance is not uncommon. Primary resistance to metronidazole and clarithromycin[3,4] is common in our locality and significantly affect the effectiveness of standard eradication therapy.[5,6]
Levofloxacin-based therapy is recently found to be an effective alternative triple therapy for H. pylori eradication, and is comparable or better than traditional quadruple therapy.[7,8,9,10,11,12,13,14,15] However, a recent local study showed that levofloxacin-based triple therapy and traditional quadruple therapy eradicated H. pylori infection in only 57% and 71% of resistant cases, respectively. The effectiveness of traditional quadruple therapy was even worse in those with metronidazole and clarithromycin resistance.[14,16] And, better second-line therapy for resistant H. pylori infection is needed. Levofloxacin-based quadruple therapy may be an effective alternative. This study compared the efficacy of levofloxacin-based quadruple therapy with traditional quadruple therapy using high-dose esomeprazole in resistant H. pylori infection.
Aliment Pharmacol Ther. 2007;26(7):1063-1067. © 2007 Blackwell Publishing
Cite this: Clinical Trial: Levoflaxacin-Based Quadruple Therapy was Inferior to Traditional Quadruple Therapy in the Treatment of Resistant Helicobacter pylori Infection - Medscape - Oct 01, 2007.