Retrospective analysis of the use of quadruple therapy with bismuth (Pylera®) in real-life clinical practice in Spain

Gastroenterol Hepatol. 2018 Oct;41(8):483-489. doi: 10.1016/j.gastrohep.2018.05.016. Epub 2018 Jul 2.
[Article in English, Spanish]

Abstract

Objective: The resistance of Helicobacter pylori to antibiotics is a growing problem in Spain and eradication rates must be improved. The new Spanish consensus considers quadruple therapy with bismuth as first- or second-line therapy. This study evaluated the use of Pylera® in real-life clinical practice.

Patients and methods: A cross-sectional descriptive study was conducted to evaluate the eradication rate of Helicobacter pylori in patients treated with Pylera® between March and September 2016. Patients (naïve or with previous treatment failure) were treated for 10 days. Eradication was confirmed using a breath test with urea 30 days or more after treatment. In addition, demographic, clinical-analytical and treatment-related data were collected.

Results: A total of 185 patients were included (51.6±16.19 years); 63.8% were women and 9.2% had a family history of gastric cancer. The most frequent indication was dyspepsia (55.1%). Approximately 57.8% received Pylera® as first-line therapy, while 95.7% received Pylera® in combination with omeprazole. A first-line eradication rate of 78.15% was observed in the intention-to-treat population (86.6% per protocol). There were no statistically significant differences between naïve patients and those previously treated. Nine patients abandoned the treatment (4.9%), 7 due to mild side effects and 2 due to incorrect dosing.

Conclusions: Pylera® has acceptable eradication rates in first- and second-line therapy and shows a suitable safety profile.

Keywords: Antibiotics; Antibióticos; Bismuth therapy; Helicobacter pylori; Terapia con bismuto; Tratamiento; Treatment.

MeSH terms

  • Adult
  • Aged
  • Breath Tests
  • Cross-Sectional Studies
  • Drug Evaluation
  • Drug Therapy, Combination
  • Female
  • Gastritis / drug therapy*
  • Gastritis / microbiology
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori / drug effects*
  • Humans
  • Male
  • Metronidazole / therapeutic use*
  • Middle Aged
  • Omeprazole / therapeutic use
  • Organometallic Compounds / therapeutic use*
  • Recurrence
  • Retrospective Studies
  • Tetracycline / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Organometallic Compounds
  • Metronidazole
  • Tetracycline
  • bismuth tripotassium dicitrate
  • Omeprazole