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Su1135 Pan-European Registry on H. pylori Management (HP-EuReg): Rescue Treatments
Su1135 Pan-European Registry on H. pylori Management (HP-EuReg): Rescue Treatments Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
Su1133 Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
INTRODUCTION: Due to the diversity of regimens used as second-line treatment in the Hp-EuReg study, a separate abstract has been created to describe the efficacy of these treatments. AIMS & METHODS: Our aim was to evaluate the efficacy of rescue treatments prescribed in the Hp-EuReg. A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up). RESULTS: Up to now, 1,160 second-line rescue treatments have been registered. The most commonly used treatments (51%) were quinolonecontaining triple therapies (levofloxacin 82% and moxifloxacin 18%) and bismuth quadruple therapy (11%). The remaining treatments were too diverse and reduced in number to be evaluated. Overall, eradication was not confirmed in 3.4% of treatments, and 39% of rescue treatment failures were not retreated. CONCLUSION: Quinolone-containing triple therapies offer acceptable results as rescue treatments in H. pylori eradication. Extending regimens to 14 days and/or using esomeprazole as the PPI may increase their efficacy. Bismuth quadruple therapy may be an acceptable alternative for rescue treatment.
INTRODUCTION: Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has been created to describe the rates of resistances in Europe. AIMS & METHODS: Our aim was to evaluate the resistance rates identified in the Hp-EuReg. A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up). RESULTS: So far 8,271 patients have been included and 5,734 have finished follow-up. Culture was performed in 17% of naïve patients (prior to first-line treatment), 15% in second-line, 47% in third-line, and 37% in fourth-line. Overall resistance to any antibiotic was found in 50% of first-line tested cases, 83% in second-line, 88% in thirdline and 90% in fourth-line. Table shows antibiotic resistance per antibiotic and line of treatment CONCLUSION: The mean rate of H. pylori clarithromycin resistance in European naïve patients reaches the threshold established by consensus conferences (15-20%) in which standard triple therapy should be discarded. There is a strong acquisition of antibiotic resistance after failed treatments.
Table
Table
* the sample size was not enough to draw conclusions Numbers represent prevalence of resistant strains and 95% Confidence Intervals (In parenthesis) Su1134 Pan-European Registry on H. pylori Management (HP-EuReg): Safety Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
PPI: proton pump inhibitor; A: amoxicillin; L: levofloxacin; M: moxifloxacin; mITT: modified intention-to-treat excluding those patients in which confirmation of eradication was not performed.; CI: confidence interval. Su1136 Pan-European Registry on H. pylori Management (HP-EuReg): Interim Analysis of 8,271 Patients Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
INTRODUCTION: Antibacterial treatments often cause adverse events (AEs), especially when treatment contains two or more antibiotics. AIMS: To evaluate the AEs associated with H. pylori eradication treatment in patients registered in the Hp-EuReg. METHODS: A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up).AEs were registered using a pre-defined AE list for the typically reported AEs, and with free text fields for uncommon AEs. RESULTS: Of the 5,734 patients that have finished follow-up, 17% (95%CI=16-18%) presented at least one AE. The majority of patients suffered only one (6% of patients) or two (4%) AEs, although up to 5 or 6 different events occurred in some patients (0.3% and 0.1%, respectively). The most common AE was dysgeusia (metallic taste) in 6% of cases, followed by nausea in 5.1%, and diarrhoea in 5%. Most AEs (59%; 95%ci=57-61%) were mild and only 3% (95%CI=2.3-3.7%) were of severe intensity; in any case, they only caused treatment discontinuation in 3.9%(95%CI=3.4-4.4%) of patients. The average length of ARs was 6.7 days. Most common free text field AEs were headache (0.9%), candidiasis (oral 0.7%, vaginal 0.3%) and constipation (0.2%). CONCLUSION: H. pylori eradication treatment causes AEs in a relevant proportion of the patients (17%). However, the intensity is mostly mild and on average lasted less than a week. Adverse events only caused treatment discontinuation in a minority (4%) of the patients.
INTRODUCTION: Due to the diversity of H. pylori strains, resistances and geographical particularities, the most efficient management strategy is still to be found. AIM: To systematically register the clinical practice of European gastroenterologists regarding H. pylori infection and treatment (31 countries, 250 recruiting investigators). METHODS: A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up). RESULTS: Up to now, 8,271 patients have been included, and 5,734 have finished followup (58% females, 85% caucasian, mean age 57 years). 3.9% had drug allergies (76% to penicillin). 52% of indications were dyspepsia. 21% had gastroduodenal ulcer. 78% were treatment naïve, 16% second-line, 4.8% third-line, 1.3% fourth-line, and 0.4% fifth-line. Culture was performed in 15% of cases (50% presenting antibiotic resistance). 57% of prescriptions were triple regimens, 11% non-bismuth quadruple concomitant, 11% sequential, and 6.4% bismuth-quadruple. 35% of patients had adverse events, although mostly mild (59%) and short lasting (6.7 days), causing treatment discontinuation in only 3.9% of cases. Given the great diversity of included regimens, detailed results for first-line, rescue treatments, and adverse events will be presented as separate abstracts. CONCLUSION: H. pylori management by gastroenterologists in Europe is extremely diverse, and in most settings suboptimal. Continuation of this registry may offer valuable information to improve this management.
S-417
AGA Abstracts
AGA Abstracts
PPI and clarithromycin) represents a second-line rescue option in the presence of penicillin allergy.
Su1133 Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
INTRODUCTION: Due to the diversity of regimens used as second-line treatment in the Hp-EuReg study, a separate abstract has been created to describe the efficacy of these treatments. AIMS & METHODS: Our aim was to evaluate the efficacy of rescue treatments prescribed in the Hp-EuReg. A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up). RESULTS: Up to now, 1,160 second-line rescue treatments have been registered. The most commonly used treatments (51%) were quinolonecontaining triple therapies (levofloxacin 82% and moxifloxacin 18%) and bismuth quadruple therapy (11%). The remaining treatments were too diverse and reduced in number to be evaluated. Overall, eradication was not confirmed in 3.4% of treatments, and 39% of rescue treatment failures were not retreated. CONCLUSION: Quinolone-containing triple therapies offer acceptable results as rescue treatments in H. pylori eradication. Extending regimens to 14 days and/or using esomeprazole as the PPI may increase their efficacy. Bismuth quadruple therapy may be an acceptable alternative for rescue treatment.
INTRODUCTION: Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has been created to describe the rates of resistances in Europe. AIMS & METHODS: Our aim was to evaluate the resistance rates identified in the Hp-EuReg. A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up). RESULTS: So far 8,271 patients have been included and 5,734 have finished follow-up. Culture was performed in 17% of naïve patients (prior to first-line treatment), 15% in second-line, 47% in third-line, and 37% in fourth-line. Overall resistance to any antibiotic was found in 50% of first-line tested cases, 83% in second-line, 88% in thirdline and 90% in fourth-line. Table shows antibiotic resistance per antibiotic and line of treatment CONCLUSION: The mean rate of H. pylori clarithromycin resistance in European naïve patients reaches the threshold established by consensus conferences (15-20%) in which standard triple therapy should be discarded. There is a strong acquisition of antibiotic resistance after failed treatments.
Table
Table
* the sample size was not enough to draw conclusions Numbers represent prevalence of resistant strains and 95% Confidence Intervals (In parenthesis) Su1134 Pan-European Registry on H. pylori Management (HP-EuReg): Safety Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
PPI: proton pump inhibitor; A: amoxicillin; L: levofloxacin; M: moxifloxacin; mITT: modified intention-to-treat excluding those patients in which confirmation of eradication was not performed.; CI: confidence interval. Su1136 Pan-European Registry on H. pylori Management (HP-EuReg): Interim Analysis of 8,271 Patients Adrian G. McNicholl, Antonio Gasbarrini, Bojan Tepes, Dmitry S. Bordin, Frode Lerang, Marcis Leja, Theodore Rokkas, Dino Vaira, Oleg Shvets, Limas Kupcinskas, Angeles Perez Aisa, Anthony T. Axon, György M. Buzás, Ilkay Simsek, Miroslava Katicic, Jose C. Machado, Vincent Lamy, Krzysztof Przytulski, Lyudmila Boyanova, Peter Bytzer, Christoph Beglinger, Lisette Capelle, Adrian Goldis, Lea Veijola, Miroslav Vujasinovic, Alain Huerta, Jorge Perez-Lasala, Maria Caldas, Mercedes Ramas, Francis Megraud, Colm A. O'Morain, Javier P. Gisbert
INTRODUCTION: Antibacterial treatments often cause adverse events (AEs), especially when treatment contains two or more antibiotics. AIMS: To evaluate the AEs associated with H. pylori eradication treatment in patients registered in the Hp-EuReg. METHODS: A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up).AEs were registered using a pre-defined AE list for the typically reported AEs, and with free text fields for uncommon AEs. RESULTS: Of the 5,734 patients that have finished follow-up, 17% (95%CI=16-18%) presented at least one AE. The majority of patients suffered only one (6% of patients) or two (4%) AEs, although up to 5 or 6 different events occurred in some patients (0.3% and 0.1%, respectively). The most common AE was dysgeusia (metallic taste) in 6% of cases, followed by nausea in 5.1%, and diarrhoea in 5%. Most AEs (59%; 95%ci=57-61%) were mild and only 3% (95%CI=2.3-3.7%) were of severe intensity; in any case, they only caused treatment discontinuation in 3.9%(95%CI=3.4-4.4%) of patients. The average length of ARs was 6.7 days. Most common free text field AEs were headache (0.9%), candidiasis (oral 0.7%, vaginal 0.3%) and constipation (0.2%). CONCLUSION: H. pylori eradication treatment causes AEs in a relevant proportion of the patients (17%). However, the intensity is mostly mild and on average lasted less than a week. Adverse events only caused treatment discontinuation in a minority (4%) of the patients.
INTRODUCTION: Due to the diversity of H. pylori strains, resistances and geographical particularities, the most efficient management strategy is still to be found. AIM: To systematically register the clinical practice of European gastroenterologists regarding H. pylori infection and treatment (31 countries, 250 recruiting investigators). METHODS: A Local Coordinator was selected from each country with more than 10 H. pylori references in PubMed. Each Coordinator selected a representative group of recruiting investigators from his/her country. An e-CRF was created to systematically register all adult patients infected with H. pylori. Variables included: Patient's demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes (H. pylori cure rates, compliance and follow-up). RESULTS: Up to now, 8,271 patients have been included, and 5,734 have finished followup (58% females, 85% caucasian, mean age 57 years). 3.9% had drug allergies (76% to penicillin). 52% of indications were dyspepsia. 21% had gastroduodenal ulcer. 78% were treatment naïve, 16% second-line, 4.8% third-line, 1.3% fourth-line, and 0.4% fifth-line. Culture was performed in 15% of cases (50% presenting antibiotic resistance). 57% of prescriptions were triple regimens, 11% non-bismuth quadruple concomitant, 11% sequential, and 6.4% bismuth-quadruple. 35% of patients had adverse events, although mostly mild (59%) and short lasting (6.7 days), causing treatment discontinuation in only 3.9% of cases. Given the great diversity of included regimens, detailed results for first-line, rescue treatments, and adverse events will be presented as separate abstracts. CONCLUSION: H. pylori management by gastroenterologists in Europe is extremely diverse, and in most settings suboptimal. Continuation of this registry may offer valuable information to improve this management.
S-417
AGA Abstracts
AGA Abstracts
PPI and clarithromycin) represents a second-line rescue option in the presence of penicillin allergy.