Helicobacter Pylori Management Research Articles

Role of proton pump inhibitors dosage and duration in Helicobacter pylori eradication treatment: Results from the European Registry on H. pylori management.

Management of Helicobacter pylori (H. pylori) infection requires co-treatment with proton pump inhibitors (PPIs) and the use of antibiotics to achieve successful eradication. To evaluate the role of dosage of PPIs and the duration of therapy in the effectiveness of H. pylori eradication treatments based on the 'European Registry on Helicobacter pylori management' (Hp-EuReg). Hp-EuReg is a multicentre, prospective, non-interventionist, international registry on the routine clinical practice of H. pylori management by European gastroenterologists. All infected adult patients were systematically registered from 2013 to 2022. Overall, 36,579 patients from five countries with more than 1000 patients were analysed. Optimal (≥90%) first-line-modified intention-to-treat effectiveness was achieved with the following treatments: (1) 14-day therapies with clarithromycin-amoxicillin-bismuth and metronidazole-tetracycline-bismuth, both independently of the PPI dose prescribed; (2) All 10-day (except 10-day standard triple therapy) and 14-day therapies with high-dose PPIs; and (3) 10-day quadruple therapies with clarithromycin-amoxicillin-bismuth, metronidazole-tetracycline-bismuth, and clarithromycin-amoxicillin-metronidazole (sequential), all with standard-dose PPIs. In first-line treatment, optimal effectiveness was obtained with high-dose PPIs in all 14-day treatments, in 10- and 14-day bismuth quadruple therapies and in 10-day sequential with standard-dose PPIs. Optimal second-line effectiveness was achieved with (1) metronidazole-tetracycline-bismuth quadruple therapy for 14- and 10days with standard and high-dose PPIs, respectively; and (2) levofloxacin-amoxicillin triple therapy for 14days with high-dose PPIs. None of the 7-day therapies in both treatment lines achieved optimal effectiveness. We recommend, in first-line treatment, the use of high-dose PPIs in 14-day triple therapy and in 10-or 14-day quadruple concomitant therapy in first-line treatment, while standard-dose PPIs would be sufficient in 10-day bismuth quadruple therapies. On the other hand, in second-line treatment, high-dose PPIs would be more beneficial in 14-day triple therapy with levofloxacin and amoxicillin or in 10-day bismuth quadruple therapy either as a three-in-one single capsule or in the traditional scheme.

Analysis of Clinical Phenotypes through Machine Learning of First-Line H. pylori Treatment in Europe during the Period 2013-2022: Data from the European Registry on H. pylori Management (Hp-EuReg).

The segmentation of patients into homogeneous groups could help to improve eradication therapy effectiveness. Our aim was to determine the most important treatment strategies used in Europe, to evaluate first-line treatment effectiveness according to year and country. Data collection: All first-line empirical treatments registered at AEGREDCap in the European Registry on Helicobacter pylori management (Hp-EuReg) from June 2013 to November 2022. A Boruta method determined the "most important" variables related to treatment effectiveness. Data clustering was performed through multi-correspondence analysis of the resulting six most important variables for every year in the 2013-2022 period. Based on 35,852 patients, the average overall treatment effectiveness increased from 87% in 2013 to 93% in 2022. The lowest effectiveness (80%) was obtained in 2016 in cluster #3 encompassing Slovenia, Lithuania, Latvia, and Russia, treated with 7-day triple therapy with amoxicillin-clarithromycin (92% of cases). The highest effectiveness (95%) was achieved in 2022, mostly in Spain (81%), with the bismuth-quadruple therapy, including the single-capsule (64%) and the concomitant treatment with clarithromycin-amoxicillin-metronidazole/tinidazole (34%) with 10 (69%) and 14 (32%) days. Cluster analysis allowed for the identification of patients in homogeneous treatment groups assessing the effectiveness of different first-line treatments depending on therapy scheme, adherence, country, and prescription year.

Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg)

BackgroundThe recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four...

Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management.

Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe. The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori-infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed. A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29-99% in <50 years to 60-99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed. A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.

Effectiveness of first and second-line empirical treatment in Italy: Results of the European registry on Helicobacter pylori management.

The optimal management of naïve and not naïve Helicobacter pylori patients remains unclear. Therefore, it is essential to evaluate whether the actual clinical practice mirrors the indications suggested by the guidelines. This study aimed to assess the effectiveness and the safety of the empirical first- and second-line treatments prescribed to patients enroled at Italian centres participating in the European Registry on H. pylori Management (Hp-EuReg). The Hp-EuReg is an international multicentre prospective non-interventional registry starting in 2013 aiming to evaluate the management of H. pylori infection by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables assessed included demographics, previous eradication attempts, treatment regimen, effectiveness, and tolerance. Overall, 3723 patients from 2013 to February 2021 were included: 2996 and 727 received an empirical first- and second-line treatment, respectively. According to the modified ITT analysis, among the first-line regimens, only the bismuth quadruple therapy with three-in-one-single capsule (BQT-TSC), the concomitant, and the sequential treatment - all lasting 10 days - achieved an eradication rate >90%. Among the second-line regimens, only the 10-day BQT-TSC reported an effectiveness >90%. High-dose PPI twice daily also significantly increased the effectiveness of some therapies. The BQT-TSC was the regimen with the highest incidence of adverse events. Only quadruple therapies lasting at least 10days achieved over 90% eradication rates among the empirical first- and second-line regimens. It remains unclear whether high-dose PPI twice daily can improve the efficacy of quadruple treatment.

Current trends in the treatment of H. pylori infection in Ukraine: results of the European Registry on Helicobacter pylori Management (Hp EuReg)

Current trends in the treatment of H. pylori infection in Ukraine: results of the European Registry on Helicobacter pylori Management (Hp EuReg)&#x0D; The European Registry on Helicobacter pylori Management (Hp EuReg) was established to evaluate the efficacy and safety of the different eradication H. pylori treatments, as well as to audit H. pylori infection consensus and clinical guidelines implementation. The current study presents data from a sample of patients from Ukraine who were registered in the Hp EuReg until February 2022.&#x0D; The aim was to assess the frequency, effectiveness and safety of treatment against H. pylori infection in Ukraine.&#x0D; Materials and methods. The Hp EuReg, an international multicenter prospective non‑interventional registry, was launched in 2013 and is promoted by the European Helicobacter and Microbiota Study Group (www.helicobacter.org). The Hp EuReg protocol was approved by the Ethics Committee of La Princesa University Hospital (Madrid, Spain) and registered with Clinical Trials.gov under the code NCT02328131. The effectiveness analysis included mainly a modified intention‑to‑treat (mITT) analysis, aiming to mimic the clinical practice outcomes and including all records with a confirmatory test after the eradication treatment, regardless of compliance. Given that some treatment regimens were used only in a small number of patients, only regimens with a relevant number of patients were selected for analyses.&#x0D; Results. Overall 841 patients (54 % women, 46 % men), whose average age (SD) was 48.35 (± 15.52) were included in the register. The main method for diagnosing on‑going H. pylori infection was histology, and the use of urea breath tests and stool antigen tests was low — (approximately 6 % of cases). Assessment of bacterial antibiotic resistance was performed in 13 % of patients, with less than 1 % reporting a positive result. More than half of the patients received quadruple therapy and 40 % triple therapy. Over 90 % of patients were treatment‑ naïve. Almost all patients received low‑dose proton pump inhibitors (PPIs), and a smaller proportion received standard (7.2 %) or high‑dose PPIs (1.2 %). Low‑doses PPI prescriptions negatively affected the effectiveness of therapy: in treatment‑naïve patients’ overall effectiveness was below 85 %, while the use of standard‑ and high‑doses of PPIs achieved 100 % eradication rates in all patients. Despite the fact that the duration of therapy in the vast majority of patients was at least prescribed for 10 days, there were cases (12 %) of administration of 7‑day therapy with the reported suboptimal (&lt; 90 %) effectiveness. In those prescribed with a first‑line treatment of 7 — 10 days, the eradication rate was 82 %, while therapy for 14 days provided 100 % treatment eradication success. In the overall mITT analysis, the use of therapy in naïve patients resulted in the eradication of H. pylori in more than 90 % of patients. It is noteworthy that effectiveness with PPI+ amoxicillin + levofloxacin was below 84 %, suboptimal according to the most up‑to‑date consensus. The administered therapy was well tolerated, which allowed to complete the treatment of more than 90 % of patients, and the incidence of adverse events was less than 4 % in naïve patients, while in patients with repeated courses of therapy it was more than 3 times higher.&#x0D; Conclusions. In Ukraine, the frequency of use of validated non‑invasive methods (urea breath tests and stool antigen test) to detect H. pylori infection is very low. However, Ukrainian doctors often use methods to assess the antibiotic resistance of Helicobacter pylori, which certainly helps to increase the rate of therapy‑guided eradication. The vast majority of eradication therapies administered to patients in the Ukrainian population corresponds to the current guidelines, but very often PPIs were administered in low doses and there were still some cases of regimens lasting 7 days, even in those patients receiving a second‑line therapy, which reduced the treatment effectiveness. Even though overall effectiveness of eradication therapy was over 90 %., there is a need to closely monitor treatment management. Prescribed first‑line therapy was well tolerated by patients — more than 98 % of patients completed treatment.&#x0D;

European Registry on Helicobacter pylori Management (Hp-EuReg): Most relevant results for clinical practice

BackgroundThe ideal treatment approach for H. pylori infection has not yet been defined; therefore, the most effective management strategies for adult patients need to be identified to ensure clinical practice is aligned with the best standard of care. Our aim was to perform a review of research studies from the European Registry on H. pylori management (Hp-EuReg) by synthesizing the most clinically relevant information from each published manuscript.MethodsAll research studies published between 2013 and 2022, evaluating any information related to H. pylori infection management within the Hp-EuReg, a long-term registry of routine clinical practice by gastroenterologists in Europe, were included in the review.ResultsOverall, 26 studies have been published to date, where 12 evaluated the overall European data and the remaining were performed locally among the 28 participating countries. Eighteen studies evaluated the effectiveness of first- and/or second-line treatment, where one focused on penicillin allergic patients, six focused on specific treatment schemes, one evaluated the role of statins as a concomitant drug when combined with the eradication therapy, one assessed the adverse event profile of treatments, one evaluated the bacterial antibiotic resistance trends, and a last one reported on the common mistakes in routine clinical practice of European gastroenterologists.ConclusionThe Hp-EuReg had a major influence on the routine clinical practice of European gastroenterologists, improving H. pylori eradication treatment success, allowing to make recommendations in line with the current consensus guidelines and potentially serving as a model for other diseases.

Experience with Rifabutin-Containing Therapy in 500 Patients from the European Registry on Helicobacter pylori Management (Hp-EuReg).

Background: First-line Helicobacter pylori (H. pylori) treatments have been relatively well evaluated; however, it remains necessary to identify the most effective rescue treatments. Our aim was to assess the effectiveness and safety of H. pylori regimens containing rifabutin. METHODS: International multicentre prospective non-interventional European Registry on H. pylori Management (Hp-EuReg). Patients treated with rifabutin were registered in AEG-REDCap e-CRF from 2013 to 2021. Modified intention-to-treat and per-protocol analyses were performed. Data were subject to quality control. Results: Overall, 500 patients included in the Hp-EuReg were treated with rifabutin (mean age 52 years, 72% female, 63% with dyspepsia, 4% with peptic ulcer). Culture was performed in 63% of cases: dual resistance (to both clarithromycin and metronidazole) was reported in 46% of the cases, and triple resistance (to clarithromycin, metronidazole, and levofloxacin) in 39%. In 87% of cases rifabutin was utilised as part of a triple therapy together with amoxicillin and a proton-pump-inhibitor, and in an additional 6% of the patients, bismuth was added to this triple regimen. Rifabutin was mainly used in second-line (32%), third-line (25%), and fourth-line (27%) regimens, achieving overall 78%, 80% and 66% effectiveness by modified intention-to-treat, respectively. Compliance with treatment was 89%. At least one adverse event was registered in 26% of the patients (most frequently nausea), and one serious adverse event (0.2%) was reported in one patient with leukopenia and thrombocytopenia with fever requiring hospitalisation. Conclusion: Rifabutin-containing therapy represents an effective and safe strategy after one or even several failures of H. pylori eradication treatment.

Helicobacter pylori Management Is Associated with Predominantly Negative Patient Experiences: Results from a Focused Qualitative Analysis.

Helicobacter pylori eradication is associated with reduced gastric cancer and peptic ulcer disease incidence and mortality. Factors influencing patients' experiences surrounding H. pylori diagnosis and management are not well-described. Current patient perceptions can influence adherence to treatment, and also their anxieties related to this potentially carcinogenic condition. The objective of this study was to understand the patient experience surrounding H. pylori management and to qualitatively construct a contextual framework to inform and guide providers who manage patients with H. pylori infection. We conducted a qualitative analysis using a focus group and one-on-one telephone interviews. An iterative inductive/deductive approach was applied to recorded transcripts to identify and hierarchically order themes. Patient experience was defined according to major themes within a structured health behavior framework. Theme saturation was achieved with thirteen participants (mean age 50.4years; 62% female; 38% non-Hispanic white). Qualitative analysis yielded a total of 987 codes that resulted in five major themes related to the patient H. pylori experience: context of decision-making; health beliefs; barriers experienced; cues to action; and impact of new knowledge. These themes aligned with the Health Behavior Model framework. Participants were motivated to treat H. pylori. However, the experience was more often perceived negatively versus positively. The perceived patient-provider interaction contributed most prominently to the negative experience compared to other patient experiences, including treatment-related side effects. Internal cues, including symptoms and fear of cancer, modified participants' perceptions and motivation to accept treatment. Patient experiences related to H. pylori management are predominantly negative. Increasing providers' awareness about patients' values, beliefs, anxieties, and expectations surrounding H. pylori diagnosis/treatment may improve provider-patient communication and, ideally, related outcomes.

Antibiotic Resistance Prevalence and Trends in Patients Infected with Helicobacter pylori in the Period 2013-2020: Results of the European Registry on H. pylori Management (Hp-EuReg).

Background: Bacterial antibiotic resistance changes over time depending on multiple factors; therefore, it is essential to monitor the susceptibility trends to reduce the resistance impact on the effectiveness of various treatments. Objective: To conduct a time-trend analysis of Helicobacter pylori resistance to antibiotics in Europe. Methods: The international prospective European Registry on Helicobacter pylori Management (Hp-EuReg) collected data on all infected adult patients diagnosed with culture and antimicrobial susceptibility testing positive results that were registered at AEG-REDCap e-CRF until December 2020. Results: Overall, 41,562 patients were included in the Hp-EuReg. Culture and antimicrobial susceptibility testing were performed on gastric biopsies of 3974 (9.5%) patients, of whom 2852 (7%) were naive cases included for analysis. The number of positive cultures decreased by 35% from the period 2013–2016 to 2017–2020. Concerning naïve patients, no antibiotic resistance was found in 48% of the cases. The most frequent resistances were reported against metronidazole (30%), clarithromycin (25%), and levofloxacin (20%), whereas resistances to tetracycline and amoxicillin were below 1%. Dual and triple resistances were found in 13% and 6% of the cases, respectively. A decrease (p < 0.001) in the metronidazole resistance rate was observed between the 2013–2016 (33%) and 2017–2020 (24%) periods. Conclusion: Culture and antimicrobial susceptibility testing for Helicobacter pylori are scarcely performed (<10%) in Europe. In naïve patients, Helicobacter pylori resistance to clarithromycin remained above 15% throughout the period 2013–2020 and resistance to levofloxacin, as well as dual or triple resistances, were high. A progressive decrease in metronidazole resistance was observed.

Evaluation of the Effectiveness of Helicobacter pylori Eradication Regimens in Lithuania during the Years 2013-2020: Data from the European Registry on Helicobacter pylori Management (Hp-EuReg).

Background and Objectives: The prevalence of H. pylori in Eastern Europe remains quite high; however, there is insufficient data on the eradication regimens and their effectiveness. Therefore, the objective of the study was to evaluate the diagnostic methods and treatment of H. pylori infection as well as their adherence to Maastricht V/Florence consensus during the years 2013–2020 in Lithuania. Materials and Methods: Sub-study of the “European Registry on H. pylori Management” (Hp-EuReg), international multicenter prospective non-interventional registry of the routine clinical practice. Lithuanian data from the years 2013–2020 were analyzed for effectiveness on a modified intention-to-treat (mITT) basis. 2000 adult patients, diagnosed with H. pylori infection, were included. Data were compared to the European Maastricht V guidelines. Results: Triple-therapy was used in 90% of the cases. In 91% of the first-line prescriptions, standard triple therapy (STT) was used. The most common second-line treatment was a combination of PPI, amoxicillin and levofloxacin (PPI+A+L) (47%). The overall effectiveness in 552 cases valid for analysis was 90% by mITT. In first-line treatment, the STT effectiveness was 90% and second-line treatment with PPI+A+L achieved 92% by mITT. Increasing overall H. pylori eradication rates were observed: from 72% in 2013 to more than 90% in 2018–2020, as well as a shift from 7 to 10–14 days treatments duration throughout 2013–2020. Conclusions: In Lithuania, the prescribed eradication regimens for H. pylori were in accordance with the international guidelines but diagnostic methods and treatment duration only partially met Maastricht V/Florence guidelines. The eradication effectiveness was improved progressively during the years 2018–2020, reaching ≥90% cure rates.

Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg).

The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management." Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.

Room for Improvement in the Treatment of Helicobacter pylori Infection: Lessons from the European Registry on H. pylori Management (Hp-EuReg).

Managing Helicobacter pylori infection requires constant decision making, and each decision is open to possible errors. The aim was to evaluate common mistakes in the eradication of H. pylori, based on the "European Registry on Helicobacter pylori management". European Registry on Helicobacter pylori management is an international multicentre prospective noninterventional registry evaluating the decisions and outcomes of H. pylori management by European gastroenterologists in routine clinical practice. Countries recruiting more than 1000 patients were included (26,340 patients). The most common mistakes (percentages) were: (1) To use the standard triple therapy where it is ineffective (46%). (2) To prescribe eradication therapy for only 7 to 10 days (69%). (3) To use a low dose of proton pump inhibitors (48%). (4) In patients allergic to penicillin, to prescribe always a triple therapy with clarithromycin and metronidazole (38%). (5) To repeat certain antibiotics after eradication failure (>15%). (6) Failing to consider the importance of compliance with treatment (2%). (7) Not to check the eradication success (6%). Time-trend analyses showed progressive greater compliance with current clinical guidelines. The management of H. pylori infection by some European gastroenterologists is heterogeneous, frequently suboptimal and discrepant with current recommendations. Clinical practice is constantly adapting to updated recommendations, although this shift is delayed and slow.

Assessment of first-line eradication treatment in Greece: data from the European Registry on Helicobacter pylori management (Hp-EuReg).

BackgroundHelicobacter pylori (H. pylori) is the most common chronic bacterial infection. Its management has to rely on local effectiveness, given the geographical variability of bacterial antibiotic resistance. We evaluated treatment effectiveness in naïve patients in Greece, as part of the European Registry on the management of H. pylori (Hp-EuReg).MethodsPatients were registered in the AEG-REDCap Electronic Case Report Form from 2013-2020. All cases with a first-line treatment were included. Modified intention-to-treat (mITT) analysis was used.ResultsA total of 547 patients from 5 medical institutions were treated with the following regimens: concomitant with proton pump inhibitors (PPIs), clarithromycin, amoxicillin and metronidazole (concomitant-C+A+M) (38%); hybrid with PPI, clarithromycin, amoxicillin and metronidazole (hybrid-C+A+M) (20%); sequential with PPI, clarithromycin, amoxicillin and tinidazole (sequential-C+A+T) (12%); sequential with PPI, clarithromycin, amoxicillin and metronidazole (sequential-C+A+M) (12%); concomitant with PPI, clarithromycin, amoxicillin and tinidazole (concomitant-C+A+T) (8%); triple with PPI, clarithromycin and amoxicillin (triple-C+A) (7%); and other (3%). Overall compliance was 99%. Triple-C+A, sequential-C+A+T, sequential-C+A+M and concomitant-C+A+T were used from 2013-2015. The respective mITT cure rates (95% confidence interval) were 92% (78-98), 87% (76-94), 67% (54-78) and 91% (79-98). Since 2015, patients were also treated with concomitant-C+A+M and hybrid-C+A+M regimens, with respective mITT cure rates of 90% (85-94) and 88% (80.5-94). Adverse events were reported by 31% of the patients, dysgeusia being the most frequent (15%).Conclusions“Optimized” H. pylori therapies should achieve cure rates over 90%. In Greece, at present, only non-bismuth quadruple concomitant regimens achieve this target and can be recommended as first-line treatment.

European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain.

The management of Helicobacter pylori infection has to rely on previous local effectiveness due to the geographical variability of antibiotic resistance. The aim of this study was to evaluate the effectiveness of first and second-line H. pylori treatment in Spain, where the empirical prescription is recommended. A multicentre prospective non-interventional registry of the clinical practice of European gastroenterologists concerning H. pylori infection (Hp-EuReg) was developed, including patients from 2013 until June 2019. Effectiveness was evaluated descriptively and through a multivariate analysis concerning age, gender, presence of ulcer, proton-pump inhibitor (PPI) dose, therapy duration and compliance. Overall, 53 Spanish hospitals were included, and 10,267 patients received a first-line therapy. The best results were obtained with the 10-day bismuth single-capsule therapy (95% cure rate by intention-to-treat) and with both the 14-day bismuth-clarithromycin quadruple (PPI-bismuth-clarithromycin-amoxicillin, 91%) and the 14-day non-bismuth quadruple concomitant (PPI-clarithromycin-amoxicillin-metronidazole, 92%) therapies. Second-line therapies were prescribed to 2448 patients, with most-effective therapies being the triple quinolone (PPI-amoxicillin-levofloxacin/moxifloxacin) and the bismuth-levofloxacin quadruple schemes (PPI-bismuth-levofloxacin-amoxicillin) prescribed for 14 days (92%, 89% and 90% effectiveness, respectively), and the bismuth single-capsule (10 days, 88.5%). Compliance, longer duration and higher acid inhibition were associated with higher effectiveness. “Optimized” H. pylori therapies achieve over 90% success in Spain.

European registry on Helicobacter pylori management (Hp-EuReg) as a tool to evaluate and improve clinical practice in Moscow

to evaluate the effectiveness of the standard triple therapy (amoxicillin, clarithromycin, a proton pump inhibitor) and the standard triple therapy plus bismuth tripotassium dicitrate. Observational, prospective, multicenter study, carried out in one single Russian centre A.S. Loginov Moscow Clinical Scientific Center as part of the Hp-EuReg. Patients were included from 2013 to November 2019 by Russian gastroenterologists. A total of 647 patients were collected and 330 were administered either standard triple therapy ((amoxicillin, clarithromycin, a proton pump inhibitor) or standard triple therapy plus bismuth tripotassium dicitrate. Invasive methods is dominates in the initial diagnosis of H. pylori: the frequency of use of the quick urease test decreased from 50% in 2013 to 31% in 2019. Serology was used in 27.9%. There has been an increase in the use of the13C-urea breath test from 13% in 2013 to 31% in 2019. The histological method (7.5%) and the stool antigen test (3.2%) were used less frequently. For eradication control non-invasive methods are mostly used:13C-UDT (82.7%) and the stool antigen test (14.4%). The effectiveness of standard triple therapy (mITT) was 68% with a 7-day course, 79% with a 10-day course, and 70% with a 14-day course. Combination of bismuth and standard triple therapy eradicates H. pylori (mITT) in 63%, 75% and 89%, respectively. An improvement in the clinical practice of managing patients with H. pylori infections has been noted. The standard triple therapy in combination with bismuth tripotassium dicitrate, prescribed for 14 days, is more effective.

Pan-European Registry on Helicobacter pylori management. Results from Ferencváros, Budapest, 2013-2019

Introduction: The Pan-European Registry on Helicobacter pylori management was conceived in 2013 to monitor eradication practices in Europe for 10 years. Aim: To assess the efficacy of different eradication regimens in a single outpatient clinic of gastroenterology. Method: Between 2013 and 2019, 247 patients were registered in a prospective non-interventional study. The infection was diagnosed either by endoscopy, histology, rapid urease test or 13C-urea breath test. As first-line treatment, the patients received either a 7-day triple regimen (any of PPI + amoxicillin + clarithromycin or tinidazole), 10-day modified sequential treatment (PPI + amoxicillin for 5 days + tinidazole and levofloxacin for 5 days), 10-day quadruple concomitant treatment (PPI + amoxicillin + tetracycline or doxycycline + metronidazole or tinidazole) or bismuth-based quadruple treatment. Bismuth or non-bismuth based quadruple or alternative regimens were given as second- or third-line treatment. Results: The eradication rates on per protocol basis were: 82.7% (95% confidence interval: 68.1-97.4) (first-line regimens), 85.2% (75.4-94.9) (sequential treatment), 95.1% (89.6-100) (concomitant treatment) and 82.6% (69.7-95.9) (bismuth-based quadruple regimen). Second-line regimens achieved 65.2% (48.2-83.0) and third-line therapy 54.5% (19.4-86.6), respectively. Conclusion: The first-line concomitant regimen was superior to triple and not significantly better than the sequential or bismuth-based treatment. Second- and third-line regimens achieved largely suboptimal results. Orv Hetil. 2019; 160(47): 1856-1863.

Helicobacter Pylori Treatment Results in Slovenia in the Period 2013-2015 as a Part of European Registry on Helicobacter Pylori Management.

BackgroundHelicobacter pylori (H. pylori) is the most common chronic bacterial infection in the world affecting over 50% of the world’s population. H. pylori is a grade I carcinogen, responsible for the development of 89 % of noncardia gastric cancers. In the present study we analyzed the data for H. pylori eradication treatments in Slovenia.Patients and methodsSlovenia is a part of the European Registry on Helicobacter pylori Management from the beginning. In seven medical institutions data for H. pylori eradication treatments was collected for 1774 patients from April 16th 2013 to May 15th 2016. For further modified intention to treat (mITT) analysis 1519 patients were eligible and for per protocol (PP) analysis 1346 patients.ResultsPatients’ dropout was 11.4%. Eradication rate for 7 day triple therapy with proton pump inhibitor (PPI) + Clarithromycin (C) + Amoxicillin (A) was 88.7% PP and 72.0% mITT; for PPI + C + Metronidazole (M) 85.2% PP and 84.4% mITT. Second line 14 day therapy PPI + A + Levofloxacin had 92.3% eradication rate PP and 87.1% mITT. Ten to fourteen day Bismuth quadruple therapy was the therapy in difficult to treat patients. At the end all patients that adhered to prescribed regimens were cured of their H. pylori infection.ConclusionsHigh dropout rate deserves further analysis. Slovenia is still a country with < 15% H. pylori resistance to clarithromycin, triple therapy with PPI plus two antibiotics reaches PP eradication rate > 85%, but mITT eradication rates are suboptimal.

Development of a Pan-European register on Helicobacter Pylori management. Preliminary results

Development of a Pan-European register on Helicobacter Pylori management. Preliminary results

Helicobacter pylori management in primary care

Helicobacter pylori is a Gram-negative bacterium that chronically infects the stomach of more than 50% of the human population, and represents the major cause of gastric cancer, gastric lymphoma, gastric autoimmunity and peptic ulcer diseases [1–4]. The International Agency for Research on Cancer classifies H. pylori as a human carcinogen for distal gastric cancer. Eradicating the bacterium, in high-risk populations, reduces the incidence of gastric cancer [5]. Likewise, antibiotic treatment leads to the regression of gastric MALT lymphoma [2]. H. pylori also contributes to other conditions, such as vitamin B12 and iron deficiencies, idiopathic thrombocytic purpura, and growth retardation in children [6]. Current guidelines indicate that the eradication of H. pylori infection is considered mandatory in patients with peptic ulcer and gastric malignancies, such as gastric adenocarcinoma and MALT lymphoma [6, 7]. Furthermore, it is recommended in patients with non-ulcer dyspepsia, especially in those with the evidence of macroscopic or microscopic mucosal abnormalities (erosions, intestinal metaplasia, atrophy), naive non-steroidal anti-inflammatory drugs (NSAIDs) users, chronic NSAIDs users, first-degree relatives of gastric cancer patients as well as in unexplained iron deficiency anaemia, and idiopathic thrombocytopenic purpura. Low-dose aspirin (ASA) therapy is widely used in primary care because of the proved efficacy in both primary and secondary prevention of cardiovascular events [8]. A synergistic interaction between H. pylori infection and NSAIDs has been extensively documented although the benefits of H. pylori eradication in NSAIDs users are conflicting [6, 9–11]. H. pylori has been shown to increase, by almost seven times, the risk of upper gastrointestinal complications in chronic NSAIDs users [12, 13]. The relationship between H. pylori infection and NSAIDs in gastroduodenal pathology is complex. Since both NSAIDs and H. pylori can cause peptic ulcers, H. pylori eradication can only be expected to prevent the recurrence of H. pylori ulcers, and while it may also reduce the incidence of ulcers among those with both H. pylori and NSAID use, the effects will vary depending on the proportion with real H. pylori ulcers in the population studied [6]. Zullo et al. [14] designed a very interesting study (reported in the current issue) to assess the management of H. pylori infection in a very large cohort of chronic NSAID users in primary care clinical settings. H. pylori was being used only in a minority (less than 20%) of primary care patients receiving chronic NSAID therapy. H. pylori was eventually cured in two-third of the infected cases. The low alertness towards such H. pylori infection in these patients suggests a need for prompt implementation of current guidelines. Furthermore, the results obtained by Zullo et al. [14], other large meta-analysis studies, strongly support the concept that patients requiring long-term NSAIDs/ASA therapy should be tested and cured of the infection [9, 14, 15] because the cure of H. pylori infection contributes to the reduction of potential life-threatening gastrointestinal critical events (such as gastroduodenal bleeding) in primary care unstable patients. M. M. D’Elios E. Silvestri G. Emmi D. Prisco PatologiaMedica, AOU Careggi, Largo Brambilla 3, 50134 Florence, Italy