Introduction

Bismuth-based quadruple therapy (BQT) is recommended as the first-line therapy for Helicobacter pylori eradication as it is not associated with resistance. Tegoprazan, a new, fast, and strong potassium-competitive acid blocker, has been approved for the treatment of gastric acid-related diseases in México. However, real-world clinical data regarding this drug are scarce. We aimed to compare the Helicobacter pylori eradication rates of tegoprazan- and omeprazole-based quadruple therapy.

Aims & Methods

Aim: To investigate the efficacy and safety profiles of tegoprazan-based BQT (TBMT) versus omeprazole-based BQT (OBMT) for H. pylori eradication.
Methods: We included patients older than 18 with an H. pylori infection without a history of H. pylori eradication who visited two centers between January 2024 and April 2024. H. pylori infection was diagnosed using histology. Patients received tegoprazan 50 mg BID , bismuth subcitrate 300 mg QID, metronidazole 500 mg QID, and doxycycline 100 mg QID for 14 days. An historic control groups was used as comparator. Historic controls were age-sex matched subjects that received omeprazole 40 mg BID , bismuth subcitrate 300 mg QID, metronidazole 500 mg QID, and doxycycline 100 mg QID, in the previous year.

Results

Until now, 80 patients have been included (40 TBMT and 40 OBMT). Most common indication for erradication was dyspeptic symptoms (78%), followed by peptic ulcer disease (10%), folicular gastritis (9%) and familiar hystory of cance (2.5%). Eradication rates of TBMT and OBMT were 90% and 77.4% (=OR 2.61, CI 95% 0.73-9.37, p=0.12), respectively. There was no significant difference in the rate of adverse events between the TBMT and OBMT groups (42.5% vs. 55,5%, p = 0.37). Nausea was the most common adverse effect (37.5% vs 40%, p=0.92) , followed by abdominal pain (12.5% vs 17.5%, p=0.16%)Adherence to the treatments was similar between groups (> 90%, 10% vs 12%, p=0.98)

Conclusion

TBMT showed a noninferior eradication rate and similar adverse events to OBMT as a first-line eradication regimen. Our results suggest that tegoprazan might be substituted for proton pump inhibitors in H. pylori eradication regimens in Mexico. A further randomized controlled trial es required to confirm our findings.

Disclosure

JMRT has served as advisory board for Takeda, Asofarma, Carnot and and Biocodex. Also is a speaker for Takeda, Asofarma, Alfasigma, Carnot, Chinoin, Medtronic, Ferrer, and Sanofi. ECA and LRVD are speakers for Carnot and Asofarmna. ACC and GM do not have any conflict of interest

Clinical Case Summary

A 71-year-old female presented to the gastroenterology clinic following a two year history of dysphagia and sensation of food sticking in the oesophagus. Her dysphagia was limited to solid foods, and symptoms were not exacerbated by positional change. Pain was mostly localised around the sternal notch where she would have the sensation of a food bolus. Over the preceding 2 years, she had experienced about 7.5kg of weight loss with no constitutional symptoms of fevers or fatigue. Her past medical history included hypertension, dyslipidaemia, lower back pain, cold agglutinin disease, monoclonal B lymphocytosis and peripheral arterial disease. On examination, there were no signs of malnourishment or palpable lymph nodes in the axilla, neck or supraclavicular region. Her abdomen was soft and non-tender. Given largely non-illuminating blood results, an oesophageal-gastroduedonoscopy was performed. However, no findings were noted, specifically no oesophageal webs, Zenker diverticulum, gastroparesis, trachealisation of the oesophagus or corrosive pathology. H. pylori was also not isolated on histopathology. A barium swallow was then performed which showed extensive external compression of the proximal third of the oesophagus at the level of the arch of the aorta, most indicative of dysphagia lusoria (Fig 1). Computed tomography angiography (CTA) showed retroesophageal aberrant right subclavian artery bifurcating from the ascending aorta independent of a brachiocephalic artery and causing external oesophageal compression (Fig 2 & 3). Given this definitive diagnosis, the patient was then seen in clinic where management of dysphagia lusoria was explained. Despite ongoing symptoms, the patient decided to continue with conservative management and lifestyle modifications, which included eating smaller bites and increase in fluid intake. Although an extensive compression typically requires surgical intervention, our patient was stable at two-year follow-up (Fig 4 A-B).

References

Figure 1: Barium swallow examination showing extrinsic compression of the proximal third of the oesophagus at the level of the aortic arch (white arrow).
Figure 2: Axial view of computed tomography angiography (CTA) showing the posterior course of the retroesophageal aberrant right subclavian artery.
Figure 3: Axial view of computed tomography angiography (CTA) showing compression of oesophagus (white arrow) by the retroesophageal aberrant right subclavian artery (white arrowhead).
Figure 4: Computed tomography angiography (CTA) multi-planar reconstruction (MPR) showing the posterior course of the right subclavian artery (white arrow), crossing the mediastinum and compressing the oesophagus. A. coronal view B. Sagittal view

Disclosure

None.

Introduction

There is limited evidence regarding how the dosage of each individual drug affects the effectiveness of the different first-line bismuth-based quadruple therapy regimens.

Aims & Methods

To analyse the effectiveness of first-line bismuth quadruple regimens according to the dosage of the different drugs used. Prospective, non-interventional registry of the clinical practice of European gastroenterologists on the management of H. pylori infection (Hp-EuReg) between 2013 and 2024. Only first-line bismuth quadruple regimens with more than 100 cases were included, and effectiveness was analysed by modified intention-to-treat (mITT) based on the different dosages.

Results

A total of 10,767 first-line records were analysed (Table 1). The clarithromycin-amoxicillin-bismuth (CAB) quadruple regimen showed effectiveness >90% regardless of the daily dose of bismuth, using A and C at standard doses. The tetracycline-metronidazole-bismuth (TMB) quadruple regimen achieved effectiveness >90% with T doses of at least 1,500 mg/day, M 1,500 mg/day, and bismuth at least 480 mg/day, with no improvement seen when the bismuth dose was increased further. The amoxicillin-metronidazole-bismuth (AMB) quadruple regimen showed mITT >90% with A at 2,000 mg/day, M at least 1,000 mg/day, and bismuth at 480 mg/day, without relevant improvement when increasing the M dose. The clarithromycin-metronidazole-bismuth (CMB) regimen showed mITT ≥90% with M doses of 800 mg/day or higher, C 1,000 mg/day, and bismuth 480 mg/day, with no improvement seen with higher daily doses of bismuth. In the amoxicillin-levofloxacin-bismuth (ALB) quadruple therapy, mITT was >90% across all regimens, with no differences observed when increasing the L dose above 500 mg/day. The rest of the regimens studied did not reach mITT >90%.

Conclusion

Several first-line bismuth quadruple regimens (CAB, TMB, AMB, CMB, and ALB) are highly effective (>90%) in clinical practice in Europe. Increasing the daily dose of bismuth above 480 mg did not yield additional benefit, supporting the use of standard bismuth dosages in routine management.

Disclosure

Dr. Javier P. 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. Olga P. Nyssen has served as a speaker or has received research funding from Mayoly, Allergan, Diasorin, Biocodex, Juvisé and Richen. Dr. Samuel J. Martínez-Domínguez has served as a speaker for Juvisé. Dr. Ángel Lanas has served as a speaker for Juvisé. The remaining authors declare no conflicts of interest.

Introduction

Despite the availability of clinical guidelines, a wide range of alternative Helicobacter pylori (H. pylori) eradication regimens continue to be used in routine clinical practice. Data on the frequency and effectiveness of these less frequently prescribed regimens remain limited.

Aims & Methods

Aim: To evaluate the prescription patterns and effectiveness of less frequently prescribed eradication regimens within the European Registry on Helicobacter pylori Management (Hp-EuReg).
Methods: International, multicentre, prospective, non-interventional registry on the management of H. pylori infection, ongoing since 2013. For this analysis, treatment regimens prescribed in fewer than 5% of all cases were classified as 'less frequently prescribed'. Additionally, therapies not previously categorized in the registry database were also included. Treatment effectiveness was assessed using modified intention-to-treat (mITT) and per-protocol (PP) analyses.

Results

Overall, 260 less frequently prescribed regimens were identified, representing 5.5% of all recorded prescriptions (82,510). A total of 2,853 (63%) of these regimens were used as first-line therapy. Among these less frequently prescribed regimens, the most frequently used first-line treatments encompassed bismuth-containing quadruple therapy with PPI–clarithromycin–metronidazole–bismuth (20%), followed by non-bismuth hybrid quadruple therapy with clarithromycin–amoxicillin–metronidazole (9.5%), and dual therapy with PPI–amoxicillin (8.6%). In second-line, the most common regimens were triple therapies, such as the PPI–amoxicillin–moxifloxacin (16%), PPI–clarithromycin–levofloxacin (11%), and PPI–metronidazole–levofloxacin (9.5%). In third-line, the most frequently used regimes were bismuth-based quadruple regimens including PPI–metronidazole–doxycycline–bismuth (27%), followed by triple therapies with PPI–clarithromycin–levofloxacin (6.8%) and PPI–amoxicillin–moxifloxacin (5.6%). In the fourth-line, the most frequent prescriptions were: bismuth-based quadruple therapies including PPI–amoxicillin–rifabutin–bismuth (30%) and PPI–metronidazole–doxycycline–bismuth (11%). Finally, the fifth treatment-line accounted for some less common treatments, such as the dual therapy with PPI–amoxicillin (19%) and the triple therapy with PPI–amoxicillin–bismuth (18%). Effectiveness and frequency of use in first-, second- and third-line of treatment are described in Table 1. Antibiotic-free regimens such as the combination of a PPI with a probiotic —generally Lactobacillus bulgaricus or Lactobacillus reuteri—were prescribed as alternative therapeutic approaches in 104 cases (2.3%), achieving 74% mITT and 76% PP overall effectiveness.
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Conclusion

Among the various less frequently used H. pylori eradication regimens, only a few (such as the PPI-clarithromycin-metronidazole-bismuth regimen and the hybrid regimen including clarithromycin–amoxicillin–metronidazole) achieved first-line eradication rates above 90%. In subsequent treatment lines, effectiveness was highly variable and often suboptimal. These findings highlight the importance of evidence-based treatment selection to optimize treatment outcomes.

Disclosure

Conflict of interest statement
Olga P. Nyssen has served as a speaker or has received research funding from Allergan, Mayoly Spindler, Richen, Biocodex and Juvisé.
Javier P. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from Mayoly, Allergan/Abbvie, Diasorin, Richen, Juvisé, Biocodex.
The remaining authors declare no conflicts of interest.

Introduction

The number of gastroesophageal reflux disease (GERD) patients that do not improve sufficiently by standard treatment is relatively high. Multichannel intraluminal impedance and pH monitoring (MII-pH) is the gold standard for diagnosing GERD, and it can be useful for selecting secondary treatment. However, in some cases, secondary treatments are not remarkably effective even when selected based on the diagnosis. On the other hand, the clinical value of the symptom–reflux association (SRA) obtained using MII-pH remains unknown.

Aims & Methods

The current study aimed to investigate the effect of SRA on the efficacy of secondary treatment in refractory true GERD.
This study included patients who underwent MII-pH monitoring for evaluating proton pump inhibitor (PPI)- or potassium-competitive acid blocker (P-CAB)-refractory GERD symptoms and who were diagnosed with abnormal acid reflux (acid exposure time > 6%). Patients with a positive symptom index (SI) and symptom association probability (SAP) on the MII-pH monitoring were included in the SRA-positive group and the remaining ones in the SRA-negative group. The differences in the subsequent treatment efficacy between the two groups were retrospectively analyzed. Treatment efficacy was evaluated using the Frequency Scale for the Symptoms of GERD (FSSG) questionnaire.

Results

Of the 192 patients with PPI-/PCAB-refractory GERD, 41 (21.4%) were diagnosed with abnormal acid reflux. Among them, 30 (7 in the SRA-positive group and 23 in the SRA-negative group) underwent symptom assessments before and after treatment. The SRA-positive group had a significantly greater symptom improvement after treatment compared with the SRA-negative group (FSSG score changes: −13.0 ± 6.5 vs −5.4 ± 8.2, p = 0.016).

Conclusion

SRA evaluation is effective in predicting secondary treatment outcomes in patients with abnormal acid reflux.