The segmentation of patients into homogeneous groups could help to improve eradication therapy ef... more 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 (...
ObjectiveTo evaluate the use, effectiveness and safety ofHelicobacter pyloriempirical rescue ther... more ObjectiveTo evaluate the use, effectiveness and safety ofHelicobacter pyloriempirical rescue therapy in third and subsequent treatment lines in Europe.DesignInternational, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis.ResultsOverall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatm...
SummaryThe authors report on an acute renal failure occuring in a 34-year old man clue to leptosp... more SummaryThe authors report on an acute renal failure occuring in a 34-year old man clue to leptospira icterohaemorrhagiae. The diagnosis is evoked clinically: association of jaundice, acute renal failure, fever, elevated leucocytosis in a fisherman. The serological studies confirm the clinical suspicion. Hemodialysis was successful. Recent literature is reviewed. Pathogenesis—like in ethers tubular intertitial nephritis—is not convincingly established. Pathogenies mecanisms have been postulated for leptospirosis.
After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain ... more After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of current study was to assess the effectiveness and safety of second-line empirical treatment in Europe. This international, multicenter, prospective non-interventional Registry aimed to evaluate the decisions and outcomes of H. pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered at AEG-REDCap up to February 2021. Patients allergic to penicillin and those having received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. Overall, 5,055 patients received empirical second-line treatment. Triple-therapy with amoxicillin and levofloxacin was most commonly prescribed (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple-therapy or levofloxacin-containing quadruple-therapy (with bismuth). In patients receiving triple-therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple-treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, three-in-one single capsule or levofloxacin-bismuth quadruple-therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. Empirical second-line regimens including 14-day quinolone triple-therapies, 14-day levofloxacin-bismuth quadruple-therapy, 14-day tetracycline-bismuth classical quadruple therapy, and 10-day bismuth quadruple-therapy (as single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates; ClincialTrials.gov number, NCT02328131.
Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNichol... more 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, Gyorgy M. Buzas, 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
Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has ... more 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.
Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has ... more 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.
In a first step, midazolam 0.1 mg/kg, midazolam 0.05 mg/kg and diazepam 0.15 mg/kg administered i... more In a first step, midazolam 0.1 mg/kg, midazolam 0.05 mg/kg and diazepam 0.15 mg/kg administered intravenously were blindly evaluated as a sedating preparation in 3 groups of each 30 patients undergoing gastroscopy. Although amnesia is better with midazolam 0.1 mg/kg, the induced sedation is protracted, which is not to be wished in ambulatory patients. On the other side, diazepam 0.15 mg/kg was locally less well tolerated. Taking into consideration the efficacy and the general and local tolerance, the dose of midazolam 0.05 mg/kg seems the best compromise. In a second step, the specific benzodiazepine antagonist flumazenil was blindly evaluated at two intravenous doses, 1 mg and 0.5 mg, against placebo for reversal of midazolam (0.1 mg/kg) induced sedation in gastroscopy patients. 1 mg of flumazenil (and to a lesser degree 0.5 mg) suppresses the sedation and amnesia induced by midazolam and normalizes attention and sensori-motor functions. However a certain degree of resedation can r...
Background Helicobacter pylori eradication is a challenge in penicillin allergy. Aim To assess th... more Background Helicobacter pylori eradication is a challenge in penicillin allergy. Aim To assess the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin. Methods Prospective multicenter study. Patients allergic to penicillin were given a first-line treatment comprising (a) 7-day omeprazole-clarithromycin-metronidazole and (b) 10-day omeprazole-bismuth-tetracycline-metronidazole. Rescue treatments were as follows: (a) bismuth quadruple therapy; (b) 10-day PPI-clarithromycin-levofloxacin; and (c) 10-day PPI-clarithromycin-rifabutin. Eradication was confirmed by 13 C-urea breath test. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by questionnaires. Results In total, 267 consecutive treatments were included. (1) First-line treatment: Per-protocol and intention-totreat eradication rates with omeprazole-clarithromycinmetronidazole were 59 % (62/105; 95 % CI 49-62 %) and 57 % (64/112; 95 % CI 47-67 %). Respective figures for PPI-bismuth-tetracycline-metronidazole were 75 % (37/ 49; 95 % CI 62-89 %) and 74 % (37/50; 95 % CI (61-87 %) (p \ 0.05). Compliance with treatment was 94 and 98 %, respectively. Adverse events were reported in 14 % with both regimens (all mild). (2) Second-line treatment: Intention-to-treat eradication rate with omeprazole-clarithromycin-levofloxacin was 64 % both after triple and quadruple failure; compliance was 88-100 %, with 23-29 % adverse effects (all mild). (3) Third-/fourth-line treatment: Intention-to-treat eradication rate with PPIclarithromycin-rifabutin was 22 %.
Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has ... more 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.
The segmentation of patients into homogeneous groups could help to improve eradication therapy ef... more 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 (...
ObjectiveTo evaluate the use, effectiveness and safety ofHelicobacter pyloriempirical rescue ther... more ObjectiveTo evaluate the use, effectiveness and safety ofHelicobacter pyloriempirical rescue therapy in third and subsequent treatment lines in Europe.DesignInternational, prospective, non-interventional registry of the clinical practice of European gastroenterologists. Data were collected and quality reviewed until October 2021 at Asociación Española de Gastroenterología-Research Electronic Data Capture. All cases with three or more empirical eradication attempts were assessed for effectiveness by modified intention-to-treat and per-protocol analysis.ResultsOverall, 2144 treatments were included: 1519, 439, 145 and 41 cases from third, fourth, fifth and sixth treatment lines, respectively. Sixty different therapies were used; the 15 most frequently prescribed encompassed >90% of cases. Overall effectiveness remained <90% in all therapies. Optimised treatments achieved a higher eradication rate than non-optimised (78% vs 67%, p<0.0001). From 2017 to 2021, only 44% of treatm...
SummaryThe authors report on an acute renal failure occuring in a 34-year old man clue to leptosp... more SummaryThe authors report on an acute renal failure occuring in a 34-year old man clue to leptospira icterohaemorrhagiae. The diagnosis is evoked clinically: association of jaundice, acute renal failure, fever, elevated leucocytosis in a fisherman. The serological studies confirm the clinical suspicion. Hemodialysis was successful. Recent literature is reviewed. Pathogenesis—like in ethers tubular intertitial nephritis—is not convincingly established. Pathogenies mecanisms have been postulated for leptospirosis.
After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain ... more After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of current study was to assess the effectiveness and safety of second-line empirical treatment in Europe. This international, multicenter, prospective non-interventional Registry aimed to evaluate the decisions and outcomes of H. pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered at AEG-REDCap up to February 2021. Patients allergic to penicillin and those having received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. Overall, 5,055 patients received empirical second-line treatment. Triple-therapy with amoxicillin and levofloxacin was most commonly prescribed (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple-therapy or levofloxacin-containing quadruple-therapy (with bismuth). In patients receiving triple-therapy containing levofloxacin or moxifloxacin, and levofloxacin-bismuth quadruple-treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, three-in-one single capsule or levofloxacin-bismuth quadruple-therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. Empirical second-line regimens including 14-day quinolone triple-therapies, 14-day levofloxacin-bismuth quadruple-therapy, 14-day tetracycline-bismuth classical quadruple therapy, and 10-day bismuth quadruple-therapy (as single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates; ClincialTrials.gov number, NCT02328131.
Pan-European Registry on H. pylori Management (HP-EuReg): Bacterial Resistance Adrian G. McNichol... more 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, Gyorgy M. Buzas, 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
Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has ... more 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.
Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has ... more 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.
In a first step, midazolam 0.1 mg/kg, midazolam 0.05 mg/kg and diazepam 0.15 mg/kg administered i... more In a first step, midazolam 0.1 mg/kg, midazolam 0.05 mg/kg and diazepam 0.15 mg/kg administered intravenously were blindly evaluated as a sedating preparation in 3 groups of each 30 patients undergoing gastroscopy. Although amnesia is better with midazolam 0.1 mg/kg, the induced sedation is protracted, which is not to be wished in ambulatory patients. On the other side, diazepam 0.15 mg/kg was locally less well tolerated. Taking into consideration the efficacy and the general and local tolerance, the dose of midazolam 0.05 mg/kg seems the best compromise. In a second step, the specific benzodiazepine antagonist flumazenil was blindly evaluated at two intravenous doses, 1 mg and 0.5 mg, against placebo for reversal of midazolam (0.1 mg/kg) induced sedation in gastroscopy patients. 1 mg of flumazenil (and to a lesser degree 0.5 mg) suppresses the sedation and amnesia induced by midazolam and normalizes attention and sensori-motor functions. However a certain degree of resedation can r...
Background Helicobacter pylori eradication is a challenge in penicillin allergy. Aim To assess th... more Background Helicobacter pylori eradication is a challenge in penicillin allergy. Aim To assess the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin. Methods Prospective multicenter study. Patients allergic to penicillin were given a first-line treatment comprising (a) 7-day omeprazole-clarithromycin-metronidazole and (b) 10-day omeprazole-bismuth-tetracycline-metronidazole. Rescue treatments were as follows: (a) bismuth quadruple therapy; (b) 10-day PPI-clarithromycin-levofloxacin; and (c) 10-day PPI-clarithromycin-rifabutin. Eradication was confirmed by 13 C-urea breath test. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by questionnaires. Results In total, 267 consecutive treatments were included. (1) First-line treatment: Per-protocol and intention-totreat eradication rates with omeprazole-clarithromycinmetronidazole were 59 % (62/105; 95 % CI 49-62 %) and 57 % (64/112; 95 % CI 47-67 %). Respective figures for PPI-bismuth-tetracycline-metronidazole were 75 % (37/ 49; 95 % CI 62-89 %) and 74 % (37/50; 95 % CI (61-87 %) (p \ 0.05). Compliance with treatment was 94 and 98 %, respectively. Adverse events were reported in 14 % with both regimens (all mild). (2) Second-line treatment: Intention-to-treat eradication rate with omeprazole-clarithromycin-levofloxacin was 64 % both after triple and quadruple failure; compliance was 88-100 %, with 23-29 % adverse effects (all mild). (3) Third-/fourth-line treatment: Intention-to-treat eradication rate with PPIclarithromycin-rifabutin was 22 %.
Due to the importance of antibacterial resistance, a separate abstract of the Hp-EuReg study has ... more 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.
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