Effectiveness and Safety of Pylera® in Patients Infected by Helicobacter Pylori: A Multicenter, Retrospective, Real Life Study

Dig Dis. 2018;36(4):264-268. doi: 10.1159/000487391. Epub 2018 Apr 17.

Abstract

Background: Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori.

Methods: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed.

Results: A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8-1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5-1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9-20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush.

Conclusions: Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.

Keywords: Antibiotics; Bismuth-containing therapy; Helicobacter pylori; Safety; Treatment.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / therapeutic use*
  • Bismuth / therapeutic use
  • Demography
  • Drug Therapy, Combination
  • Endoscopy
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology*
  • Helicobacter pylori / physiology*
  • Humans
  • Male
  • Metronidazole / therapeutic use
  • Middle Aged
  • Organometallic Compounds / therapeutic use
  • Retrospective Studies
  • Tetracycline / therapeutic use
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Organometallic Compounds
  • Metronidazole
  • Tetracycline
  • bismuth tripotassium dicitrate
  • Bismuth