Approximately half of the world’s population is infected by Helicobacter pylori (H. pylori), the main cause of gastritis, peptic ulcer and gastric cancer.
A new study has determined that quadruple therapies with bismuth to eradicate Helicobacter pylori infection are very effective, especially those prescribed together with metronidazole-tetracycline in a single capsule.
The study is the work of a team made up of, among others, Llum Olmedo, from the International University of Catalonia, and the researchers from the Network Biomedical Research Center for Liver and Digestive Diseases (CIBEREHD) Xavier Calvet and Emili Gené, who work at the Parc Taulí University Hospital in Sabadell, Barcelona, together with Javier P. Gisbert and Olga P. Nyssen, principal investigator and scientific director of Hp-EuReg, respectively, also belonging to the CIBEREHD and the Princesa Health Research Institute (IIS-Princesa) of the La Princesa University Hospital in Madrid, in Spain. Furthermore, the publication has had the participation of very diverse institutions from all over Europe, including a wide range of patients.
The objective of the present study was to evaluate the evolution of the use, effectiveness and safety of quadruple therapies with bismuth to eradicate Helicobacter pylori infection. Data were extracted from the “European Registry on the management of Helicobacter pylori infection” (Hp-EuReg), a European multicenter prospective project of the clinical practice of gastroenterologists.
15,582 patients from 29 European countries who received empirical quadruple treatment with bismuth were included between June 2013 and December 2021. It was observed that the most frequent quadruple treatments with bismuth were those that were combined with: metronidazole-tetracycline (including its capsule format (Pylera®) and its traditional format that administers the drugs separately), clarithromycin-amoxicillin, and levofloxacin-amoxicillin. Following the marketing of the single capsule with bismuth in Europe, there has been an increase in the number of prescriptions for quadruple therapies with bismuth, reaching its peak of prescriptions in 2018, and representing 40% of total empiric prescriptions in Europe in the period 2019-2021.
Most bismuth quadruple therapies were prescribed as first-line treatments (72%).
In the global analysis of first lines, the treatment regimens that obtained an optimal eradication rate, greater than 90%, were those that combined bismuth together with metronidazole-tetracycline (including its single capsule format and its traditional format), clarithromycin- amoxicillin, and metronidazole-amoxicillin.
Regardless of the treatment line, when analyzing quadruple therapies with bismuth based on duration, it was observed that the combinations that achieved optimal effectiveness were those prescribed for 10 days together with metronidazole-tetracycline (exclusively in its single capsule format). and those administered for 14 days together with clarithromycin-amoxicillin and metronidazole-amoxicillin.
From left to right: Javier P. Gisbert, Olga P. Nyssen, Llum Olmedo, Emili Gené and Xavier Calvet. (Photos: CIBER)
Quadruple therapies with bismuth were also analyzed based on the dose of proton pump inhibitor (PPI) and it was observed that with standard/high doses (40 mg and 80 mg of omeprazole equivalent twice a day, respectively) an optimal eradication rate with the single capsule, and with the combinations with clarithromycin-amoxicillin, and metronidazole-amoxicillin.
In the case of quadruple therapy with bismuth-metronidazole-tetracycline in its traditional format, an optimal eradication rate was only obtained when using high doses of PPI.
No therapy achieved 90% cure when low-dose PPIs (20 mg omeprazole equivalent twice daily) were used.
The research team confirmed that “adherence to treatment in quadruple therapies with bismuth was greater than 95%, with at least one adverse effect observed in 40% of patients, and that 10% of these had to stop treatment due to adverse effects”.
The team’s conclusion is that quadruple therapies with bismuth are very effective, especially those prescribed together with metronidazole-tetracycline in a single capsule, and suggest that the accessibility of this therapy in those countries where it is not yet available could mean an improvement in the effectiveness of Helicobacter pylori eradication treatment.
The study is titled “Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg)”. And it has been published in the academic journal Gut. (Source: CIBER)
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