Introduction

Lithuania remains in the area with a high prevalence of H. pylori infection, which is estimated to be ~30-40%. Therefore, it is important to analyze the local H. pylori management in order to achieve better treatment results.

Aims & Methods

To evaluate the trends and effectiveness of H. pylori first- and second-line treatment prescriptions in Lithuania during 2013-2023.
Prospective, multicenter, international, non-interventionist registry on the management of H. pylori (Hp-EuReg) by European gastroenterologists. Lithuanian data from 2013 to 2023 were analysed. The effectiveness of the five most frequent first- and second-line H. pylori eradication prescriptions was evaluated using the modified intention-to-treat (mITT) analysis.

Results

In total 4,168 patients from Lithuania were included in the Hp-EuReg. The confirmation of H. pylori eradication was assessed in 37% of the first-line and 44% of the second-line cases. The overall first-line treatment effectiveness was 88%; the effectiveness of the most frequent first-line treatment prescription (standard triple therapy with amoxicillin and clarithromycin) increased from 78% in 2013 to 95% in 2023, obtaining the optimal (>90%) cure rates during the last 4 years. The overall second-line treatment effectiveness was 91%; the overall effectiveness of the most frequent second-line treatment prescription (triple therapy with amoxicillin and levofloxacin) was 92%. Since 2020 this triple therapy was taken over by bismuth quadruple therapy with amoxicillin and levofloxacin in prescription frequency – this quadruple regimen managed to maintain optimal eradication effectiveness rates during the last 6 years. The trends and effectiveness of other most frequent first- and second line prescriptions are presented in Table 1.

Conclusion

During 2013-2023 there was a trend of increasing H. pylori eradication effectiveness of the main first-line prescription, managing to maintain optimal cure rates in the last 4 years. There has been an increase in first- and second-line quadruple therapies prescriptions since the year 2018.

Introduction

The role of indications for Helicobacter pylori investigation on prescriptions and effectiveness is uncertain.

Aims & Methods

To assess the appropriateness of indications for H. pylori treatment, and its influence on prescriptions and effectiveness. International, prospective, non-interventional registry of the management of H. pylori infection by European gastroenterologists (Hp-EuReg). Treatment-näive patients registered from 2013 to July 2023 at e-CRF AEG-REDCap were included. Effectiveness was evaluated by modified intention-to-treat analysis.

Results

Overall, 53,636 treatment-naïve patients from 34 countries were analyzed. Indications were inappropriate in 2,989 (5.6%) cases. Most common indications were: dyspepsia with normal endoscopy (49%), non-investigated dyspepsia (20%), duodenal ulcer (11%), gastric ulcer (7.7%), and gastroesophageal reflux disease (GERD) (2.6%). Treatment effectiveness varied by indication: duodenal ulcer (91%), gastric ulcer (90%), preneoplastic lesions (90%), dyspepsia with normal endoscopy (89%), GERD (88%), and non-investigated dyspepsia (87%); p<0.001. Bismuth quadruple therapies reached 90% effectiveness in all indications except GERD. The effectiveness with PPI-bismuth-metronidazole-tetracycline (quadruple-BMTc) was lower in patients treated for non-investigated dyspepsia as compared to those with dyspepsia with normal endoscopy, however, in all cases cure rates were optimal (91.8% vs. 93.9%, p= 0.047). In Spain, these latter results were also confirmed in the same indications (92% vs. 94%, p=<0.05), and similar scenario was observed for quadruple-BMTc in patients with dyspepsia from Russia and Italy, but did not reach statistical significance. PPI-clarithromycin-amoxicillin-bismuth showed similar effectiveness rates for dyspepsia with normal endoscopy and non-investigated dyspepsia (93%), also confirmed in Spain, Russia and Azerbaijan. Concomitant clarithromycin-amoxicillin-tinidazole/metronidazole (CAT-CAM) achieved 90% except in patients with non-investigated dyspepsia. Most of concomitant-CAT-CAM therapies (36%) were prescribed in Spain, where the effectiveness was suboptimal in patients with non-investigated dyspepsia (87%), dyspepsia with normal endoscopy (89.8%) and GERD (89%) (p<0.001). Triple therapies showed suboptimal eradications rates in all indications with the exception of Lithuania, where optimal effectiveness was observed in patients with non-investigated dyspepsia (99%, p=0.009). Adverse events were higher in patients treated for dyspepsia with normal endoscopy as compared to duodenal ulcer (23% vs. 28%, p<0.001). Therapeutic compliance was higher in patients with duodenal ulcer and preneoplastic lesions (98% and 99%, p<0.001).

Table 1. Overall effectiveness (by modified intention-to-treat) of first-line treatment schemes.

Conclusion

In Europe, indications for H. pylori investigation could be improved in 5.6% of patients. Higher effectiveness was observed in patients treated for gastric or duodenal ulcers and preneoplastic lesions. Bismuth and non-bismuth quadruple therapies reached optimal results in almost all indications.

Disclosure

Dr. Samuel J. Martínez-Domínguez has served as a speaker for Juvisé. Dr. Ángel Lanas has served as a speaker for Juvisé. Dr. Gisbert has served as a speaker, a consultant and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Biocodex, Juvisé and Richen. Dr. Nyssen has received research funding from Mayoly, Allergan, Diasorin, Biocodex, Juvisé and Richen.

Introduction

The infection by H. pylori can be successfully treated and eradicated if the recommendations from consensus documents are followed correctly. It is essential to continuously assess the applicability of these recommendations to confirm what happens in clinical practice.

Aims & Methods

Multicentre, prospective registry evaluating the decisions and outcomes of Helicobacter pylori management by European gastroenterologists. Data were registered at AEG-REDCap e-CRF until December 2023. Modified intention-to-treat (mITT) and time trend analyses were performed.

Results

Overall, 58,334 (82%) were first-line empirical prescriptions. The total number of different therapeutic regimens prescribed exceeded 100. Triple therapy prescriptions decreased from approximately 60% during 2013/15 to 30% in 2023; likewise, non-bismuth concomitant therapy use decreased from 21% in 2013/15 to 15% in 2021/23, while three-in-one single-capsuleincreased from 0.3% in 2013/2015 to 20% in 2021/23. An increase in the average duration of treatments (from 9.8 days to 12.4 days) in 2013-2023 was identified, as well as in the use of standard/high-dose of PPIs (increasing from 36% to 60%) in 2013-2023. There was a ≈10% overall improvement in first-line mITT overall effectiveness from 86% to 94% in 11 years of evolution, both globally and in each geographic region (Table).

Conclusion

European gastroenterological practice is constantly adapting to the newest published evidence and recommendations (reducing the use of triple therapies and increasing both the duration of treatment and the dose of PPIs), with a subsequent progressive improvement in overall effectiveness.

Disclosure

Javier P. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from: Mayoly, Allergan/Abbvie, Diasorin, Richen, Juvisé and Biocodex.
Olga P. Nyssen received research funding from: Mayoly, Allergan/Abbvie, Richen, Juvisé and Biocodex.

Introduction

It is not yet clear what is the best first-line empirical therapy in patients with Helicobacter pylori (H. pylori) infection. For this reason, it is important to constantly monitor the effectiveness of the different therapies used in clinical practice.

Aims & Methods

The aim of this study was therefore to assess the effectiveness of empirical first-line treatment prescribed in Italy evaluating the European Registry on H. pylori Management (Hp-EuReg). The Hp-EuReg is an international multicentre prospective non-interventional registry recording information on H. pylori infection management since 2013. All infected adult patients enrolled were systematically registered at AEG-REDCap e-CRF. Data of all H. pylori-positive treatment-naïve patients enrolled from 2013 to December 2023 by Italian centres participating in the Hp-EuReg, were extracted, subject to quality control, and analysed. The effectiveness of the first-line treatment empirically prescribed was evaluated according to the modified intention-to-treat (including all patients that completed follow-up, i.e., a confirmatory test of success or failure available after eradication treatment), and per-protocol analysis (including all patients that completed follow-up and took at least 90% of the treatment drugs).

Results

In total, 4,144 patients were included for analysis; the mean age was 52 years (SD ± 5), and 60% of patients were women. Overall, 1.0% of the cases were allergic to penicillin. Among those non-allergic to penicillin, 10-day sequential therapy (mainly as PPI-clarithromycin-amoxicillin-tinidazole) was most commonly prescribed (54%), followed by 10-day single capsule bismuth quadruple therapy with metronidazole and tetracycline (19 %), and 10 or 14-day non-bismuth concomitant treatment (mainly as clarithromycin-amoxicillin-tinidazole) (9.3%), providing these regimens optimal cure rates (91.5%, 95.5%, 92% and 97%; respectively). Additional first-line prescriptions encompassed 7, 10 or 14-day triple therapy with PPI-clarithromycin-amoxicillin (5.5%), and 10-day triple therapy with PPI- -levofloxacin-amoxicillin (2.9%) (see Table 1).

Table 1; Effectiveness by modified intention-to-treat (mITT), and per-protocol (PP) analyses of first-line empirical treatment in patients not allergic to penicillin enrolled in the Italian centres participating in the European Registry on H. pylori management (Hp-EuReg).

Conclusion

Among the first-line empiric treatments prescribed by the Italian centres participating in the Hp-EuReg, only single-capsule bismuth quadruple therapy with metronidazole-tetracycline-bismuth, sequential therapy with clarithromycin-amoxicillin-tinidazole, and non-bismuth concomitant therapy with clarithromycin-amoxicillin-tinidazole, achieved over 90% effectiveness.

Disclosure

Olga P. Nyssen received research funding from Mayoly and Allergan; Antonio Gasbarrini served as consultant for Abbvie, Actial, Alpha-Sigma, Eisai, Gilead, Malesci; Maria Pina Dore received funding from Sanofi, Takeda; Alfredo Di Leo served as a consultant for THD SpA; Gerardo Nardone received research grant from Sofar S.p.a and Alfasigma; Francis Mégraud received research grant from Allergan, bioMerieux, Mobidiag (to the institution), and as speaker from Biocodex and Mayoly; Claudio Borghi served as speaker, consultant, and advisory member for Servier, Novo‐Nordisk, Astra‐Zeneca,Sanofi; Javier P. Gisbert served as speaker, consultant, and advisory member for or received research funding from Mayoly, Allergan, Diasorin, GebroPharma, and Riche.

Introduction

According to recent studies, the prevalence rate of H. pylori infection in Russia is over 30%, but a decreasing trend has recently been observed. Comprehensive multicenter evaluation of effectiveness of different eradication treatments in Russia has not yet been performed. One of the most efficient tools of such analysis is the on-going European Registry on H. pylori Management (Hp-EuReg), an international, prospective, multicenter, observational study, which begun in 2013.

Aims & Methods

The objective of our study was to evaluate the effectiveness of first-line empirical eradication therapy in Russia between 2013-2022 according to the data of Hp-EuReg. The treatment effectiveness was analysed by per-protocol (PP), and modified intention-to-treat (mITT), also stratifying by PPI dose (low dose - 4.5 to 27 mg omeprazole equivalent, twice daily; standard dose - 32 to 40 mg omeprazole equivalent, twice daily; high dose - 54 to 128 mg omeprazole equivalent, twice daily) and duration of treatment (7, 10 or 14 days).

Results

Overall, 8,354 patients from 14 cities in Russia who had received a first-line empirical eradication therapy between 2013 and 2022, were included. Invasive (i.e. endoscopic) methods (rapid urease test, histology/cytology) for the H. pylori primary evaluation were mostly used in almost all cities. The highest rate of ¹³C-urea breath test was observed in Rostov-on-Don (89% of cases), Saint-Petersburg (37%), Omsk (25%), Perm (25%), and Moscow (23%). The most frequently used first-line treatments were: triple (PPI, amoxicillin, clarithromycin) and triple plus bismuth (PPI, amoxicillin, clarithromycin, bismuth) therapies, accounting for more than 60% of prescriptions in almost all cities. Most cities prescribed 14-day length therapies; whereas standard PPI doses were most frequently used in Chelyabinsk (94%), Smolensk (84%), Saint-Petersburg (68%), Moscow (67%), Khabarovsk (66%) and Rostov-on-Don (54%), low PPI doses prevailed in Krasnoyarsk (80%), Izhevsk (70%), Novosibirsk (65%), Omsk (60%), and Kazan (52%). Quadruple therapy with PPI, amoxicillin, clarithromycin and bismuth achieved optimal (>90%) mIIT effectiveness in Saint-Petersburg, Perm, Chelyabinsk, and Khabarovsk, where it was more frequently used than in the remaining cities. Effectiveness of triple therapy (PPI, amoxicillin, clarithromycin) varied from 62% (Novosibirsk) to 99% (Omsk), achieving over 85% across all cities. However, high eradication rates with triple therapy prescriptions were observed in the cities with a small number of patients or in those cases where histology were the unique tests used for eradication control, possibly giving false negative results. Classic bismuth quadruple therapy (PPI, tetracycline, metronidazole, bismuth) provided optimal (>90%) mITT effectiveness in Moscow and Saint-Petersburg, where it was predominately used as compared to other cities (table 1).

Table.1 Effectiveness by modified intention-to-treat of most common first-line empirical therapies in 14 cities of Russia in 2013-2022

Conclusion

To date, in Russia, bismuth quadruple therapies either with classical metronidazole-tetracycline-bismuth or amoxicillin-clarithromycin-bismuth achieve optimal (> 90%) results, providing significantly better rates when prescribed for 14 days

Introduction

The emergence of antimicrobial resistant Helicobacter pylori (H. pylori) has impacted treatment success rates. Local audits of prescription patterns and eradication rates are necessary to assess treatment efficacy and compliance with clinical guidelines. The first Irish consensus guidelines on the management of H. pylori were published in 2017. Clarithromycin-amoxicillin triple therapy (CTT) or bismuth quadruple therapy (BQT) were the recommended first-line options. Other key recommendations included extending treatment durations to 14 days and the use of high-dose proton pump inhibitors (PPIs).

Aims & Methods

This study aimed to (i) investigate first-line H. pylori prescription patterns and cure rates over a 10-year period in Ireland, and (ii) evaluate the impact of the first Irish consensus guidelines on these trends. Data were collected at e-CRF AEG-REDCap from the European Registry on Helicobacter pylori Management (Hp-EuReg) and quality reviewed from 2013 to 2022. All treatment-naïve cases were assessed for effectiveness by modified intention-to-treat (mITT) analysis. Multivariate analysis was performed using a logistic regression model to evaluate the relationship between mITT rates and age, sex, indication, compliance, PPI dose and treatment duration.

Results

In all, data from 1,000 patients (mean age 50±15 years; 54% (n=536) female) were included in the analysis, from those 78% (n=784) were from Tallaght University Hospital, Dublin and 22% (n=216) were from Beacon Hospital, Dublin. The most common indication was dyspepsia (92%; n=920), followed by duodenal ulcer and gastric ulcer (2%; n=20 and 1%; n=10, respectively). CTT was the most common first-line treatment (88%; n=880). BQT represented 1.7% (n=17) of prescriptions. Of the reported treatment durations (n=998), 87% (n=868) were for 14 days, 4.5% (n=45) were for 10 days and 8.5% (n=85) were for 7 days. Of the reported PPI dose prescribed (n=999), 86% (n=860) were high (i.e., 80 mg omeprazole equivalent twice daily), 0.9% (n=9) were standard (i.e., 40 mg omeprazole equivalent twice daily), and 13% (n=130) were low (i.e., 20 mg omeprazole equivalent twice daily).

The eradication rate was 80.1% (95% confidence interval (CI) 77.5-82.5%) overall and 81.4% (95% CI 78.9-83.7%) for CTT. Multivariate analysis revealed that good compliance and the use of high dose PPI were significantly associated with higher overall mITT rates (odds ratio (OR) 4.5, 95% CI 1.4-14.2, p<0.05 and OR 1.9, 95% CI 1.2-2.8, p< 0.005, respectively) and CTT mITT rates (OR 4.2, 95% CI 1.2-14.2, p<0.05 and OR 1.9, 95% CI 1.1-3.2, p<0.05, respectively).

Following publication of the Irish consensus guidelines in 2017, prescriptions for 14 days therapy increased from 39% (n=82/208) pre-2017 to 99% (n=786/790; p<0.0001) and the use of high dose PPI increased from 37% (n=77/207) pre-2017 to 99% (n=783/792; p<0.0001). In line with this, overall eradication rates significantly increased from 74.5% (95% CI 68.2-80.0%) pre-2017 to 81.6% (95% CI 78.7-84.1%; p<0.05). CTT eradication rates significantly increased from 75.7% (95% CI 68.2-81.8%) pre-2017 to 82.6% (95% CI 79.6-85.1%; p<0.05).

Conclusion

CTT was the most frequently prescribed first-line therapy between 2013-2022. BQT was rarely prescribed, reflecting difficulty accessing bismuth in Ireland. While treatment success increased following publication of the Irish consensus guidelines, cure rates remain below 90%. Alternative first-line treatment strategies are required in the Irish healthcare setting.