Helicobacter pylori
 first‐line and rescue treatments in patients allergic to penicillin: Experience from the European Registry on
 H pylori
 management (Hp‐EuReg)

Nyssen, Olga P; Pérez-Aisa, Ángeles; Tepes, Bojan; Rodrigo-Sáez, Luis; Romero, Pilar Mata; Lucendo, Alfredo J.; Castro-Fernandez, Manuel; Phull, Perminder; Barrio, Jesús; Bujanda, Luis; Ortuño, Juan; Areia, Miguel; Jurecic, Natasa Brglez; Huguet, José María; Alcaide, Noelia; Voynovan, Irina; Bote, José María Botargues; Modolell, Ines; Lasala, Jorge Pérez; Ariño, Inés; Jonaitis, Laimas Virginijus; Domínguez-Cajal, Manuel; Buzás, György M.; Lerang, Frode; Perona, Monica; Bordin, Dmitry S.; Axon, T.; Gasbarrini, Antonio; Pinto, Ricardo Marcos; Niv, Yaron; Kupčinskas, Limas; Tonkic, Ante; Leja, Marcis; Rokkas, Theodore; Boyanova, Lyudmila; Shvets, Oleg; Venerito, Marino; Bytzer, Peter; Goldis, Adrian; Simsek, Ilkay; Lamy, Vincent; Przytulski, Krzysztof; Kunovský, Lumír; Capelle, Lisette G; Milosavljevic, Tomica; Caldas, Maria; Garre, Ana; Mégraud, Francis; O'Morain, Colm; Gisbert, Javier P.

doi:10.1111/hel.12686

Cited by 24 publications

(48 citation statements)

References 36 publications

(69 reference statements)

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“…In our cohort, the effectiveness of clarithromycin-containing triple therapies with either metronidazole or levofloxacin was suboptimal in the allergic to penicillin population, in agreement with previously published evidence [33]. The use of the bismuth singlecapsule in this setting has markedly increased effectiveness, achieving up to 94% in our cohort in first-line treatment, thus confirming this regimen as the current therapy of choice in this population [1,9,34].…”

Section: Discussionsupporting

confidence: 89%

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

Caldas

Pérez-Aisa²,

Castro-Fernandez³

et al. 2020

Antibiotics

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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.

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“…Since the incidence of primary resistance to CLR and LEV in H. pylori strains isolated in Poland has exceeded 15%, the conventional threshold of acceptable prevalence [13], therapies with these antibiotics is discouraged. Based on this, according to the authors of the article, it is reasonable to use bismuth quadruple therapy (bismuth salts, MTZ, TET, and proton pumps inhibitor [PPIs]) as a first line treatment [7,29], because in this case resistance to MTZ does not significantly affect the therapeutic result [30,31]. It should be borne in mind, however, that this applies to strains with low resistance levels (8-32 µg/mL), and higher resistance (>32 µg/mL) may reduce the effectiveness of this therapy from >90% to 60% [32].…”

Section: Discussionmentioning

confidence: 99%

High Primary Antibiotic Resistance of Helicobacter pylori Strains Isolated from Pediatric and Adult Patients in Poland during 2016–2018

et al. 2020

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Monitoring the antibiotic resistance of H. pylori is an important step in the effective treatment of this bacterium, thus the aim of the present study was to assess the prevalence of antimicrobial resistance of H. pylori strains isolated from pediatric and adult patients with primary infections in 2016–2018. Antral biopsies from 334 treatment-naïve patients (126 children and 208 adults) were obtained. A total of 71 clinical H. pylori strains (22 from children and 49 from adults) were isolated and examined for amoxicillin (AMX), clarithromycin (CLR), metronidazole (MTZ), tetracycline (TET), and levofloxacin (LEV) susceptibility. The activity of the antibiotics was measured by E-tests. Strains were considered as resistant to antibiotics with minimum inhibitory concentrations (MICs) equal to ≥0.125 μg/mL (AMX), ≥0.5 μg/mL (CLR), ≥8 μg/mL (MTZ), and ≥1 μg/mL (TET and LEV). The highest prevalence of antibiotic resistance in H. pylori strains was observed for CLR and MTZ, at frequencies of 54.5% and 31.8% vs. 30.6% and 46.9% for children and adults, respectively. A much lower frequency of isolation of resistant strains was demonstrated for LEV and TET, this being 9.1% and 4.5% vs. 18.4% and 4.1% for pediatric and adult patients, respectively. The presence of AMX-resistant strains was not observed. The H. pylori strains isolated from Polish patients with primary infections showed a high level of antibiotic resistance to CLR and MTZ (>30%).

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“…However, the eradication rate was only 31.8% as first‐line therapy in our previous study due to the rising prevalence of clarithromycin (29.5%) and metronidazole (42.7%) resistance 7 . Emerging data suggest that this combination has diminished its efficacy 8,9 . The latest guidelines of ESPGHAN/NASPGHAN recommended that if the strain is susceptible to CLA and MET, standard dose triple therapy with MET should be used in place of AMO; if the strain is resistant to CLA, bismuth‐based therapy with tetracycline should be used instead of AMO if the patient is older than 8 years 10 .…”

Section: Introductionmentioning

confidence: 99%

Long‐term changes in the gut microbiota after 14‐day bismuth quadruple therapy in penicillin‐allergic children

Zhou

et al. 2020

Helicobacter

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Background Penicillin‐allergic children who are infected with Helicobacter pylori constitute a relatively common subgroup. We aimed to study the short‐term and long‐term effects of bismuth quadruple therapy on gut microbiota in penicillin‐allergic children. Methods We prospectively recruited treatment‐naive children with H pylori infection and H pylori‐negative asymptomatic children as healthy controls. Patients received 14‐day bismuth quadruple therapy consisting of omeprazole, clarithromycin, metronidazole, and bismuth. Fecal samples were collected at weeks 0, 2, 6, and 52. Alterations in the gut microbiota were analyzed by 16S rRNA gene sequencing. Results Twenty‐two subjects (14 gastritis patients, 8 duodenal ulcer patients) and 23 controls participated in this study. At week 2, alpha diversity was reduced in both gastritis (P < .05) and ulcer (except P = .16 with Chao 1 index) patients compared with baseline. Some changes persisted at week 6, and all were restored at week 52. Beta diversity was significantly altered 2 weeks after treatment in the gastritis and duodenal ulcer groups (P = .001, P = .002, respectively) and restored at weeks 6 and 52. The mean relative abundance of Bacteroidetes (P < .001, P = .005, respectively) decreased and that of Proteobacteria increased (P < .001, P = .03, respectively). All alterations recovered at week 6 and 52. In both the gastritis and ulcer groups at week 2, some beneficial bacteria were decreased including Bacteroides (P < .001 and P = .003), Faecalibacterium (P < .001 and P = .02), Phascolarctobacterium (P = .002 and P = .004), Roseburia ( P < .001 and P = .13), Bifidobacterium (P = .08 and P = .04), and Blautia (P < .001 and P = .002). Some detrimental bacteria were increased including Escherichia‐Shigella (P < .001 and P = .19), Klebsiella (P < .001, and P = .09), Enterococcus (P < .001 and P = .007), and Streptococcus (P = .002 and P = .004). The changes returned to almost the pre‐eradication level 1 year after therapy. Conclusion Bismuth quadruple therapy causes short‐term dysbiosis of the gut microbiota. Most changes recovered 1‐year post‐eradication, indicating the long‐term safety of H pylori therapy.

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“…In China, a study on BQT used as a rescue therapy comparing amoxicillin plus berberine vs. tetracycline plus furazolidone found similar eradication rates (76% vs 77%) with a significantly lower rate of adverse events in the amoxicillin and berberine group 79 . The European Registry on H pylori Management (Hp‐EuReg) reported on penicillin‐allergic patients and found excellent eradication rates for bismuth as both first‐line (91%), second‐line (78%) and third‐line (75%) therapies in this cohort 80 . A Chinese study also on penicillin‐allergic patients reported 87% eradication for bismuth‐based therapy with tetracycline and metronidazole 81 .…”

Section: Bismuth‐based Therapymentioning

confidence: 65%

Review – Treatment of Helicobacter pylori infection 2020

et al. 2020

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This review summarizes important studies regarding Helicobacter pylori therapy published from April 2019 to April 2020. The main themes that emerge involve studies assessing antibiotic resistance, and there is also growing momentum behind the utility of vonoprazan as an alternative to proton pump inhibitor (PPI) therapy and also bismuth‐based regimens as a first‐line regimen. Antibiotic resistance is rising wherever it is being assessed, and clarithromycin resistance in particular has reached a point where it may no longer be a viable therapy without previous testing in many regions of the world. The evidence for the efficacy of a bismuth‐based quadruple therapy as a first‐line therapy is now very clearly established, and there is substantial evidence that it is the best performing first‐line therapy. The utility of vonoprazan as an alternative to PPI therapy, especially in resistant and difficult‐to‐treat groups, has also been considered in great detail this year, and it may offer an opportunity in the near future to reduce the problem of antibiotic resistance.

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“…In case of eradication failure, we prescribe 10-day esomeprazole + Pylera as a third-line therapy. As reported in article from Hp-EuReg data, good eradication rates (91%) can also be achieved with first-line 14-day therapy with esomeprazole-bismuth-tetracycline-metronidazole [22]. Thus, this therapy can become the second-line therapy of choice in Slovenia in patients allergic to penicillin when tetracycline will be available.…”

Section: Discussionmentioning

confidence: 90%

Helicobacter pylori Eradication Rates in Slovenia in the Period from 2017 to 2019: Data from the European Registry on H. pylori Management

Tepes¹,

Jurecic²,

Tepes³

et al. 2020

Dig Dis

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Background. Helicobacter 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 non-cardia gastric cancers. In the present study, we analyzed the data for H pylori eradication treatments in Slovenia after the 3rd National recommendations were implemented. Patients and methods. Slovenia is part of the European Registry on H pylori Management (Hp-EuReg) since the study was launched in 2013. Data were collected at AEG-REDCap e-CRF from September 2017 to December 2019. H pylori eradication treatment was assessed by modified intention-to-treat (mITT) and per-protocol (PP) analyses. Results. Overall, 823 patients from 3 medical institutions were included. Effectiveness with first line 14-day triple therapy with a proton-pomp-inhibitor (PPI), clarithromycin 500 mg, amoxicillin 1000 mg, all BID, was 93% by mITT (714 patients). In patients allergic to penicillin, first line 14-day triple therapy with PPI-clarithromycin-metronidazole achieved 83% effectiveness by mITT (35 patients). Second-line 14-day triple therapy with a PPI-amoxicillin-levofloxacin achieved 89% mITT eradication rate (51 patients). Second-line therapy with the 10-day three-in-one single capsule containing bismuth-tetracycline- metronidazole achieved optimal effectiveness (100% mITT) in 10 patients ( p=0.02). Conclusions. Slovenia is a country with < 15% H pylori resistance to clarithromycin. Triple therapy with a PPI plus two antibiotics during 14 days reported optimal effectiveness (over 90%). Ten-day quadruple bismuth second-line therapy had better results than 14-day triple therapy with levofloxacin).

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Helicobacter pylori first‐line and rescue treatments in patients allergic to penicillin: Experience from the European Registry on H pylori management (Hp‐EuReg)

Cited by 24 publications

References 36 publications

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

High Primary Antibiotic Resistance of Helicobacter pylori Strains Isolated from Pediatric and Adult Patients in Poland during 2016–2018

Long‐term changes in the gut microbiota after 14‐day bismuth quadruple therapy in penicillin‐allergic children

Review – Treatment of Helicobacter pylori infection 2020

<b><i>Helicobacter pylori</i></b> Eradication Rates in Slovenia in the Period from 2017 to 2019: Data from the European Registry on <b><i>H. pylori</i></b> Management

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