BACKGROUND: Sequential therapy has been recommended in the Maastricht IV/Florence Consensus Report as the first-line treatment for Helicobacter pylori eradication in regions with high clarithromycin resistance. However, it fails in 5-24% of infected subjects, and the recommended levofloxacin-containing triple rescue therapy only achieves a 77% eradication rate after failure of sequential therapy. AIM: To investigate the efficacy of a novel quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin for rescue treatment of sequential therapy. METHODS: This was a multicenter study in which H. pylori-infected patients who had failed sequential therapy received a 10-day quadruple therapy (esomeprazole (40 mg b.d), tripotassium dicitrato bismuthate (120 mg q.d.s.), tetracycline (500 mg q.d.s.), and levofloxacin (500 mg o.d.) for 10 days). H. pylori status was examined 6 weeks after the end of treatment. RESULTS: From July 2007 to June 2012, twenty-four subjects received 10-day quadruple therapy. The eradication rates according to intention-to-treat and per-protocol analyses were both 95.8% (23 of 24; 95% confidence interval, 87.8-103.8%). Adverse events were seen in 25.0% (6 of 24) of the patients. Drug compliance was 100.0% (24/24). CONCLUSIONS: The 10-day quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin achieves a very high eradication rate for H. pylori infection after failure of sequential therapy. It is well tolerated and has great potential to become a good choice of rescue treatment following non-bismuth-containing quadruple therapy in regions with high clarithromycin resistance.
BACKGROUND: Sequential therapy has been recommended in the Maastricht IV/Florence Consensus Report as the first-line treatment for Helicobacter pylori eradication in regions with high clarithromycin resistance. However, it fails in 5-24% of infected subjects, and the recommended levofloxacin-containing triple rescue therapy only achieves a 77% eradication rate after failure of sequential therapy. AIM: To investigate the efficacy of a novel quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin for rescue treatment of sequential therapy. METHODS: This was a multicenter study in which H. pylori-infectedpatients who had failed sequential therapy received a 10-day quadruple therapy (esomeprazole (40 mg b.d), tripotassium dicitrato bismuthate (120 mg q.d.s.), tetracycline (500 mg q.d.s.), and levofloxacin (500 mg o.d.) for 10 days). H. pylori status was examined 6 weeks after the end of treatment. RESULTS: From July 2007 to June 2012, twenty-four subjects received 10-day quadruple therapy. The eradication rates according to intention-to-treat and per-protocol analyses were both 95.8% (23 of 24; 95% confidence interval, 87.8-103.8%). Adverse events were seen in 25.0% (6 of 24) of the patients. Drug compliance was 100.0% (24/24). CONCLUSIONS: The 10-day quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, and levofloxacin achieves a very high eradication rate for H. pylori infection after failure of sequential therapy. It is well tolerated and has great potential to become a good choice of rescue treatment following non-bismuth-containing quadruple therapy in regions with high clarithromycin resistance.