Quadruple H. pylori Eradication Regimens containing bismuth and levofloxacin Successful in Treating Patients who had Failed Standard therapy

1 September, 2017

Eradication of Helicobacter pylori (H. pylori) reduces the incidence of gastric cancer and ulcer recurrence. However due to changing sensitivity profiles, the eradication rate of standard triple therapy has dropped to less than 80%, requiring new regimens. The Maastricht V consensus recommends triple therapy containing fluoroquinolones in patients who have failed standard therapy, yet the addition of bismuth is synergistic with many antimicrobials and can increase efficacy of eradication regimens.

A multicentre randomised trial compared  quadruple therapy EBTL (esomeprazole 40 mg b.d. bismuth 120 mg q.d.s. tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) versus standard non-bismuth triple therapy EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.). Both regimens were given for 10 days to patients that had failed previous first-line therapy. H. pyloristatus was assessed 6 weeks after the end of treatment.

102 H. pylori infected patients were randomised into the study (EBTL 50, EAL 52) with all included in the ITT analysis. The trial initially planned to enroll 60 patients in each arm, but because interim results showed a marked benefit for the EBTL arm, the trial was stopped. 98% of the EBTL (49 of 50) had successful eradication of H. pyloricompared to the much lower 69.2% in the EAL group (36 of 52 patients). This difference was statistically significant (difference: 28.8%; 95% CI: 15.7% to 41.9%; P<0.001). These results were upheld in the per-protocol analysis (EBTL 97.8% vs. EAL 68.6%; P<0.001). The occurrence of adverse events was similar for both groups (22.0% vs. 11.5%). Further analysis confirmed that EBTL was superior to EAL in patients who had failed either standard triple therapy (100% vs. 75.0%; P=0.010) or non-bismuth quadruple therapy (95.0% vs. 52.6%; P=0.003).

Genetic factors were also assessed; both homozygote and heterozygoteEMs of CYP2C19 experienced a higher eradication in the EBTL group (95 vs. 64% for homEM, 100 vs. 64 in hetEM). These results confirmed that a 10-day regimen of quadruple therapy containing bismuth and levofloxacin was an effective treatment for patients who had failed earlier eradication therapy with standard triple or non-bismuth quadruple therapy.

PMID: 28719592

Am J Gastroenterol. 2017 Jul 18. doi: 10.1038/ajg.2017.195. [Epub ahead of print]

Source: https://www.ncbi.nlm.nih.gov/pubmed/28719592?dopt=Abstract