IDDF2018-ABS-0076 Optimised 14-day levofloxacin sequential versus 10-day bismuth quadruple therapy containing high dose esomeprazole in the second-line and third-line treatment of helicobacter pylori – a multicenter randomised trial. (8th June 2018) - Liou, Jyh-Ming
Abstract : Background: We aimed to compare the efficacy of 14 day levofloxacin sequential therapy versus 10 day bismuth quadruple therapy in the second-line and third-line treatment of Helicobacter pylori (H. pylori) infection. Methods: H. pylori infected patients who failed after one treatment were eligible in this open labelled, multicenter, randomised trial, and were randomised to receive (1) levofloxacin sequential therapy (EAML ): esomeprazole 40 mg and amoxicillin 1 g for the first 7 days, followed by esomeprazole 40 mg, metronidazole 500 mg, and levofloxacin 250 mg for another 7 days (all twice daily); or (2) bismuth quadruple therapy (BQ) : esomeprazole 40 mg twice daily, bismuth tripotassium dicitrate 300 mg four times a day, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day, for 10 days. The primary end point was the eradication rate in the second-line treatment according to intention to treat (ITT) analysis. The minimum inhibitory concentrations were determined by agar dilution test. Results: The results were available for analysis in 398 patients up to Dec, 2017. The preliminary eradication rate in the EAML and BQ groups were 88.9% (169/190) and 91% (172/189), respectively (p=0.505) in the ITT analysis, and were 89.9% (169/188) and 96.1% (172/179) in the PP analyses, respectively (p=0.021) in the second line treatment. The efficacy of levofloxacin sequential therapy, but not bismuth quadruple therapy, appeared to be affected by levofloxacin resistance. In the third-line therapy, the eradication rate of EAML was 60% (3/5) for patients who failed after bismuth quadruple therapy. The eradication rate of BQ was 80% (12/15) for patients who failed after levofloxacin sequential therapy. The cumulative eradication rates were 95.3% (181/190) and 92.6% (175/1189) in the EAML (2nd)-BQ(3rd) and the BQ(2nd)- EAML (3rd) groups (p=0.276). The frequencies of adverse effects were 42.8% (62/145) and 81.9% (118/144) in patients treated with EAML and BQ, respectively (p<0.001). Conclusions: Levofloxacin sequential therapy and bismuth quadruple therapy are similarly effective in the second-line treatment for H. pylori infection. (Trial registration number: NCT NCT03148366 ).