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

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.