EVALUATION OF HELICOBACTER PYLORI RESISTANCE TO CLARITHROMYCIN AND LEVOFLOXACIN BY EPSILOMETER TEST IN DONG NAI PROVINCE, 2013

2014 ◽  
pp. 12-18
Author(s):  
Ngoc Quy Hue Dang ◽  
Van Huy Tran ◽  
Si Tuan Nguyen ◽  
Nguyen Dang Khoa Le ◽  
Thi Minh Thi Nguyen ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Resistance Rate ◽  
Concomitant Therapy ◽  
Secondary Resistance ◽  
Quadruple Therapy ◽  
Sensitivity Rate ◽  
The Mean ◽  
H Pylori ◽  
Mean Time ◽  
Main Factor

Background: Regimens with Clarithromycin-based and Levofloxacin-based triple were standard treatments for H.pylori eradication, but the increased prevalence of H.pylori strains resistant to Clarithromycin (CLA) and Levofloxacin (LEV) had became the main factor for treatment failure. Aims: to determine the rate of H. pylori isolates in culture and antibiogram using Epsilometer (Etest) with CLA and LEV done successfully in patients who have positive CLO test; to determine the prevalence of primary and secondary resistance of H. pylori to CLA and LEV. Materials and methods: 60 patients who presenting with gastroduodenal diseases at Thong Nhat-Dong Nai Hospital, from 11/2013 to 12/2013, with CLO test positive, were recruited to the study. H.pylori isolates were cultured with PYL medium, then antibiogram against CLA and LEV done by Epsilometer test (Etest) method with Muller Hinton Agar. Results: the rate of successful culture of H.pylori isolates was 91.7%; the mean time for H.pylori growth was 4.0±1.2 days (3-10 days), of these, 81.8% growing in 3-4 days; the successful rate of antibiograms was 89,1%; the rate of primary and secondary resistance to CLA and LEV were 64.1-100% and 29.2-100% respectively; sensitivity rate and resistance rate to both kinds of antibiotics were 20.4% and 22.4%. Conclusions: We should not choose the CLA-based and LEV-based triple therapies in treatment for patients infected with H.pylori in Dong Nai province, except when having sensitive evidence; rather, we should choose Bismuth-based quadruple therapy or use CLA with a different usage such as sequential or concomitant therapy. Key words: H.pylori, antibiotic resistance, primary culture, antibiogram

scholarly journals Efficacy of and Resistance to Rifaximin-based Quadruple Therapy in Helicobacter pylori Eradication

2020 ◽  
Vol 20 (3) ◽  
pp. 218-224
Author(s):  
Hyun Soo Kim ◽  
Hyuk Yoon ◽  
Dong Woo Shin ◽  
Dong Jun Oh ◽  
Mingu Kwon ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Rescue Therapy ◽  
Treatment Options ◽  
Treatment Protocol ◽  
Resistance Rate ◽  
Quadruple Therapy ◽  
Minimal Inhibitory Concentrations ◽  
Intention To Treat ◽  
H Pylori ◽  
Triple Regimen

Background/Aims: The treatment options for Helicobacter pylori (<i>H. pylori</i>) infection are in a state of flux: traditional triple therapies have started to fail, and new treatments are unable to achieve optimal eradication rates. Rifaximin and rifabutin are new antibiotics. The aim of this study was to evaluate the efficacy and safety of adding rifaximin to the standard triple regimen and of a rifabutin-based triple regimen as a rescue therapy for <i>H. pylori</i> eradication.Materials and Methods: We enrolled 27 <i>H. pylori</i>-positive patients who were treated with a proton pump inhibitor, amoxicillin, clarithromycin, and rifaximin for 14 days. <i>H. pylori</i> eradication was assessed by a <sup>13</sup>C-urea breath test performed 4 weeks after therapy completion. The efficacy of the therapy was based on intention-to-treat (ITT) and per-protocol (PP) analysis. We also investigated the resistance rate, compliance, and side effects associated with rifaximin therapy. Minimal inhibitory concentrations and resistance to rifabutin were evaluated using the agar dilution method.Results: Of the 27 patients, 22 completed the treatment protocol with 100% compliance; five patients withdrew. The ITT and PP eradication rates for the rifaximin-containing quadruple therapy were 70.4% (19/27) and 86.3% (19/22), respectively. Adverse events were observed in five of 22 patients (22.7%). The resistance rates to rifaximin and rifabutin were 66.7% (2/3) and 0% (0/3), respectively.Conclusions: The findings of this study show the limitations of rifaximin-based quadruple therapy and suggest the benefits of a rifabutin-based rescue regimen in South Korea.

scholarly journals The efficacy and safety of quadruple therapy without bismuth (concomitant therapy) in the treatment of patients with Helicobacter pylori - associated gastric and duodenal peptic ulcer disease

2019 ◽  
Vol 91 (8) ◽  
pp. 28-33 ◽  
Author(s):  
A M Veliev ◽  
I V Maev ◽  
D N Andreev ◽  
D T Dicheva ◽  
A V Zaborovskii ◽  
...  
Keyword(s):  
Duodenal Ulcer ◽  
Helicobacter Pylori ◽  
Side Effects ◽  
Triple Therapy ◽  
Eradication Therapy ◽  
Test System ◽  
Efficacy And Safety ◽  
Concomitant Therapy ◽  
Quadruple Therapy ◽  
H Pylori

Aim. Evaluation of the efficacy and safety of quadrupletherapy without bismuth (concomitant therapy) in patients with Helicobacter pylori - associated gastric ulcer and duodenal ulcer in the framework of a comparative research in the population of patients in Russia. Materials and methods. A prospective randomized trial was conducted, which included 210 patients with H. pylori - associated gastric/duodenal ulcer without complications. During the process of randomization, the patients were divided into three equal groups (n=70) depending on the prescribed 10-day scheme of eradication therapy (ET): the first group received the classic triple scheme (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day and Clarithromycin 500 mg 2 times a day); the second group received quadruple therapy with bismuth drugs (Omeprazole 20 mg 2 times a day, Tetracycline 500 mg 4 times a day, Metronidazole 500 mg 3 times a day, Bismuth subcitrate potassium 120 mg 4 times a day); the third group received quadruple therapy without bismuth - concomitant therapy (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day, Clarithromycin 500 mg 2 times a day and Metronidazole 500 mg 2 times a day). Diagnostics of H. pylori infection during screening and control of eradication was carried out via the fast urease biopsy sample test and urea breath test system. Control of the effectiveness of ET of the microorganism was carried out not earlier than 4 weeks after the end of the treatment. During the course of therapy, the frequency of development of side effects was assessed using a special questionnaire. Results and discussion. The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94). Quadruple therapy without bismuth was reliably more effective than the classical triple therapy in the PP selection (p=0.044883). Statistical analysis showed a tendency to poorer effectiveness of ET in patients who had previously used antibiotic therapy (OR 0.4317; 95% CI 0.1776-1.049), and in individuals with a rapid metabolism genotype - CYP2C19*1/*1 (OR 0.12; 95% CI 0.005848-2.4624). The frequency of development of side effects during the use of triple therapy was 18.5% (95% CI of 9.23-27.91), when using quadruple therapy with bismuth - 20.0% (95% CI 10.39-29.6), and with the use of quadruple therapy without bismuth - concomitant therapy - 24.2% (95% CI 13.98-34.58). Conclusion. This prospective randomized study demonstrated the high efficiency of quadruple therapy without bismuth (concomitant therapy) in the framework of eradication of H. pylori infection in Russia.

scholarly journals Trend of changes in antibiotic resistance in Helicobacter pylori from 2013 to 2019: a multicentre report from Taiwan

2020 ◽  
Vol 13 ◽  
pp. 175628482097699
Author(s):  
Chih-Ming Liang ◽  
Wei-Chen Tai ◽  
Pin-I Hsu ◽  
Deng-Chyang Wu ◽  
Chao-Hung Kuo ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Linear Trend ◽  
Eradication Therapy ◽  
Resistance Rate ◽  
Test Method ◽  
Success Rates ◽  
Primary Resistance ◽  
Secondary Resistance ◽  
H Pylori

Background: Antibiotic resistance plays a crucial role in the treatment failure of Helicobacter pylori (H. pylori) infection. This study aimed to determine the trend of changes in the primary, secondary and tertiary antibiotic resistance of H. pylori in Taiwan over the last 7 years. Methods: We retrospectively analysed H. pylori-infected isolates from patients with primary resistance ( n = 1369), secondary resistance ( n = 196) and tertiary resistance ( n = 184) from January 2013 to December 2019. The H. pylori strains were tested for susceptibility to amoxicillin, clarithromycin, levofloxacin, metronidazole and tetracycline using the Epsilometer test method. Results: A progressively higher primary resistance rate was observed for clarithromycin (11.8–20.4%, p = 0.039 in χ2 test for linear trend), levofloxacin (17.3–38.8%, p < 0.001) and metronidazole (25.6–42.3%, p < 0.001) among naïve patients who received first-line eradication therapy. The dual primary resistance to clarithromycin and metronidazole also progressively increased in a linear trend (2.4–10.4%, p = 0.009). For secondary resistance, an increase was observed for levofloxacin (30.5–64.7%, p = 0.006) and metronidazole (40.5–77.4%, p < 0.001). For tertiary resistance, the observed increase was even more significant for levofloxacin (65.9–100.0%, p = 0.106) and metronidazole (44.4–88.2%, p < 0.001). The resistance to amoxicillin and tetracycline remained very low in Taiwan regardless of primary, secondary and tertiary resistance. Conclusion: Primary, secondary and tertiary antibiotic resistance to clarithromycin, levofloxacin and metronidazole for H. pylori has been increasing in Taiwan since 2013. Treatment should be targeted for eradication success rates of more than 90%. Third-line treatment should be based on antibiotic susceptibility.

DIFFUSION METHODS FOR CLARITHROMYCIN AND LEVOFLOXACIN SUSCEPTIBILITY TESTING OF HELICOBACTER PYLORI

2014 ◽  
pp. 63-70
Author(s):  
Trung Nam Phan ◽  
Van Huy Tran ◽  
Thi Nhu Hoa Tran ◽  
Van An Le
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Alternative Therapy ◽  
Resistance Rate ◽  
Disk Diffusion ◽  
Primary Resistance ◽  
Secondary Resistance ◽  
Central Vietnam ◽  
Resistant Strains ◽  
H Pylori

Background: The rate of antibiotic resistance in H. pylori is increasing and has become a main cause for failure of treatment. Antibiogram is very important to provide optimal regimens for eradication of H.pylori infected patients. Objective: To determine the resistance prevalence to clarithromycin, levofloxacin of H.pylori strains from patients in Central Vietnam by E-test and disk diffusion isolated, assess the relationship between two diffusion methods. Methods: 56 H.pylori strains were isolated from gastric biopsies of H.pylori infected patients from 7/2012 to 8/2013, of which 13 strains originated from patients in whom eradication of the infection failed after treatment. E-test was used to determine the minimum inhibitory concentrations of clarithromycin (CH) and levofloxacin (LE). Disk diffusion was evaluated as an alternative method to determine susceptibility and compared with the E-test results. Results: In total, the resistant strains (regardless of previous eradication history) to CH, LE were 42,9% and 44,6%, respectively. The ratio of strains with secondary resistance was significantly greater than that of the strains with primary resistance, CH: 84.6% vs. 30.2%, LE: 61.5% vs 39,5% (p < 0.05). The resistance rate to LE in female was significantly higher than in male (p < 0.05). All CH-sensitive strains by E-test had the inhibition diameters of CH was ≥ 24mm and all CH-resistant strains had the inhibition diameters was ≤ 18mm (breakpoint for MIC: 1µg/ml). To LE, the inhibition diameters was ≥ 30mm can determine all LE-sensitive strains and the inhibition diameters was ≤ 26mm can determine all LE-resistant strains by E-test (breakpoint for MIC: 1µg/ml). Conclusions: High resistance rate to CH and LE, suggests that standard CH-based triple therapie may not be useful as the first-line treatment and LE-based triple therapy should not use as an alternative therapy in Central Vietnam. The disk diffusion can use as alternative phenotypic method to determine the susceptbility of H.pylori, which is more practical and inexpensive. Keywords: Helicobacter pylori, levofloxacin, clarithromycin, E-test antibiotic resistance, disk diffusion.

Synthesis, Molecular Modelling and Antibacterial Activity Against Helicobacter pylori of Novel Diflunisal Derivatives as Urease Enzyme Inhibitors

2019 ◽  
Vol 16 (4) ◽  
pp. 392-400 ◽  
Author(s):  
Göknil Pelin Coşkun ◽  
Teodora Djikic ◽  
Sadık Kalaycı ◽  
Kemal Yelekçi ◽  
Fikrettin Şahin ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibacterial Activity ◽  
Enzyme Inhibitors ◽  
Binding Modes ◽  
Bacterial Strains ◽  
Urease Enzyme ◽  
H Pylori ◽  
Ulcer Treatment ◽  
Main Factor

Background:The main factor for the prolongation of the ulcer treatment in the gastrointestinal system would be Helicobacter pylori infection, which can possibly lead to gastrointestinal cancer. Triple therapy is the treatment of choice by today&#039;s standards. However, observed resistance among the bacterial strains can make the situation even worse. Therefore, there is a need to discover new targeted antibacterial therapy in order to make success in the eradication of H. pylori infections.Methods:The targeted therapy rule is to identify the related macromolecules that are responsible for the survival of the bacteria. Thus, 2-[(2&#039;,4&#039;-difluoro-4-hydroxybiphenyl-3-yl)carbonyl]-N- (substituted)hydrazinocarbothioamide (3-13) and 5-(2&#039;,4&#039;-difluoro-4-hydroxybiphenyl-3-yl)-4- (substituted)-2,4-dihydro-3H-1,2,4-triazole-3-thiones (14-17) were synthesized and evaluated for antibacterial activity in vitro against H. pylori.Results:All of the tested compounds showed remarkable antibacterial activity compared to the standard drugs (Ornidazole, Metronidazole, Nitrimidazin and Clarithromycin). Compounds 4 and 13 showed activity as 2&#181;g/ml MIC value.Conclusion:In addition, we have investigated binding modes and energy of the compounds 4 and 13 on urease enzyme active by using the molecular docking tools.

E-Test or Agar Dilution for Metronidazole Susceptibility Testing of Helicobacter Pylori: Importance of the Prevalence of Metronidazole Resistance

2021 ◽  
Author(s):  
Jinnan Chen ◽  
Yu Huang ◽  
Zhaohui Ding ◽  
Xiao Liang ◽  
Hong Lu
Keyword(s):  
Helicobacter Pylori ◽  
Susceptibility Testing ◽  
Resistance Rate ◽  
Test Method ◽  
Major Error ◽  
Metronidazole Resistance ◽  
Agar Dilution ◽  
H Pylori ◽  
High Level ◽  
Level Resistance

Abstract Background: A number of studies have shown that E-test overestimated the presence of Helicobacter pylori (H. pylori) resistance compared to agar dilution.Objective: The purpose of this study was to explore whether E-test could be an alternative for agar dilution to detect the metronidazole susceptibility of H. pylori.Method: E-test and agar dilution were used to assess susceptibility of H. pylori to metronidazole, clarithromycin and levofloxacin in 281 clinical isolates obtained from China where resistance was high. Cohen kappa analysis, McNemar test, essential and categorical agreement analysis were performed for these two methods. Results: Overall, the result of E-test showed similar prevalence of resistance rate to all antibiotics compared with agar dilution. The essential agreement (EA) of E-test method and agar dilution in the evaluation susceptibility of H. pylori to clarithromycin and levofloxacin were moderate, with 89.0% and 79.7% respectively, but only 45.9% for metronidazole. Results showed categorical agreement (CA) between E-test and agar dilution were 100% for both clarithromycin and levofloxacin. As for metronidazole, the CA was 98.7%, no major error was identified, and rate of very major error was 1.8%.Conclusion: E-test can be an alternative method to detect the metronidazole susceptibility of H. pylori in regions where high-level resistance is common.

Culture and Susceptibility of Levofloxacin Resistant H.pylori

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Sameh Mohamed Fahiem Ghaly ◽  
Hany Ali Hussien Abd El-Rahman ◽  
Mohamed Osama Aly Aly ◽  
Ahmed Medhat Youssef Ibrahim Youssef
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Proper Time ◽  
Wide Spectrum ◽  
Signs And Symptoms ◽  
Line Treatment ◽  
Clarithromycin Resistance ◽  
Prior Use ◽  
H Pylori ◽  
Main Factor

Abstract Background Antibiotic resistance in Helicobacter pylori is the major cause of eradication failure. Prevalence of H.pylori antibiotic resistance is increasing worldwide, and it is the main factor affecting efficacy of current therapeutic regimens. Our aim is to investigate H.pylori resistant patients toward Levofloxacin and detect the most effective antibiotic in eradication of H.pylori. Objective To investigate H.pylori resistant patients toward Levofloxacin including regimens and to detect the most effective antibiotic in H.pylori eradication. Patients and Methods The present study aimed to investigate the Susceptibility of Levofloxacin Resistant H.pylori in patients who had been diagnosed and received any regimen including Levofloxacin and still signs and symptoms of H.pylori infection not releaved and after proper time of stoppage of PPI and antibiotics H.pylori Ag in stool still positive at the period from January 2019 to February 2020. Results In the present study we found a wide spectrum of resistance to rates of H. pylori, from nearly negligible rates of Rifampicin (0%), Imipenem (0%), Cefotaxime (2%), Tetracycline (6%), Doxycycline(10%), and Amoxicillin(38%). To high rates resistance to Metronidazole (100%), Erythromycin (72%), Clarithromycin (68%), Azithromycin (60%), Ciprofloxacin (52%), and Levofloxacin (48%). Conclusion Helicobacter pylori is the most common chronic bacterial infection in humans. Antibiotic resistance is a major issue nowadays. Prior use of macrolide antibiotics or metronidazole appears to increase the risk of H. pylori resistance. Clarithromycin resistance appears to be an "absolute" condition that can not be overcome by increasing the macrolide dose. Levofloxacin resistance seems to be increasing. Culture and susceptibility should be done before starting second line treatment.

scholarly journals 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)

Antibiotics ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 1058
Author(s):  
Luis Bujanda ◽  
Olga P. Nyssen ◽  
Dino Vaira ◽  
Ilaria M. Saracino ◽  
Giulia Fiorini ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Antimicrobial Susceptibility ◽  
Susceptibility Testing ◽  
Resistance Rate ◽  
Antimicrobial Susceptibility Testing ◽  
Metronidazole Resistance ◽  
Infected Adult ◽  
H Pylori ◽  
European Registry

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.

scholarly journals Antibiotic Resistance of Helicobacter pylori Strains Isolated From Pediatric Patients in Southwest China

2021 ◽  
Vol 11 ◽  
Author(s):  
Juan Li ◽  
Jianjun Deng ◽  
Zhiling Wang ◽  
Hong Li ◽  
Chaomin Wan
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Pediatric Patients ◽  
Southwest China ◽  
Pediatric Population ◽  
Primary Resistance ◽  
Secondary Resistance ◽  
Treatment Naïve ◽  
H Pylori ◽  
Resistance Rates

The number of antibiotics that are appropriate for Helicobacter pylori eradication in children is limited. Profiling regional or population-specific antibiotic resistance is essential in guiding the H. pylori eradication treatment in children. The aim of this study was to evaluate the antibiotic resistance in H. pylori strains isolated from children and adolescents in Southwest China. Gastric biopsies from 157 pediatric patients with or without previous H. pylori eradication treatment were collected for H. pylori culture. Susceptibility to amoxicillin (AML), clarithromycin (CLR), metronidazole (MTZ), levofloxacin (LEV), tetracycline (TET), furazolidone (FZD), and rifampicin (RIF) was determined by E-test or a disk diffusion assay. A total of 87 patients from three ethnic groups (Han/Tibetan/Yi) were H. pylori culture positive (55.4%). The overall resistance rates were 55.2% for CLR, 71.3% for MTZ, 60.9% for RIF, and 18.4% for LEV. No isolate was found to be resistant to AML, TET, and FZD. Among the 53 treatment-naïve pediatric patients, primary resistance rates to clarithromycin, metronidazole, levofloxacin, and rifampicin were 45.3, 73.6, 15.1, and 60.4%, respectively. Among the 34 treatment-experienced patients, secondary resistance rates to clarithromycin, metronidazole, levofloxacin, and rifampicin were 70.6, 67.6, 23.5, and 61.8%, respectively. Isolates exhibiting simultaneous resistance to clarithromycin and metronidazole were 28.3 and 52.9% among the treatment-naïve and treatment-experienced patients, respectively. In conclusion, among pediatric patients in Southwest China, resistance rates were high for clarithromycin, metronidazole, levofloxacin, and rifampicin, whereas nil resistance was found to amoxicillin, tetracycline, and furazolidone. Our data suggest that the standard clarithromycin-based triple therapy should be abandoned as empiric therapy, whereas the bismuth quadruple therapy (bismuth/PPI/amoxicillin/tetracycline) would be suitable as first-line empiric treatment regimen for this pediatric population. Tetracycline and furazolidone may be considered for treating refractory H. pylori infections in adolescent patients.

scholarly journals European Registry on Helicobacter pylori Management: single-capsule bismuth quadruple therapy is effective in real-world clinical practice

2020 ◽  
pp. 205064062097261
Author(s):  
Olga P Nyssen ◽  
Angeles Perez-Aisa ◽  
Manuel Castro-Fernandez ◽  
Rinaldo Pellicano ◽  
Jose M. Huguet ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Clinical Practice ◽  
Proton Pump Inhibitor ◽  
Proton Pump ◽  
Real World ◽  
Case Report Form ◽  
First Line ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
H Pylori

Background There has been resurgence in the use of bismuth quadruple therapy (proton pump inhibitor, bismuth, tetracycline and metronidazole) for treating Helicobacter pylori infection thanks to a three-in-one single-capsule formulation. Objective To evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy. Methods Data were collected in a multicentre, prospective registry of the clinical practice of gastroenterologists on the management of H. pylori infection, where patients were registered at the Asociación Española de Gastroenterología REDCap database on an electronic case report form until January 2020. Effectiveness by modified intention-to-treat and per-protocol as well as multivariable analysis were performed. Independent factors evaluated were: age, gender, indication, compliance, proton pump inhibitor dose and treatment line. Results Finally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e. three capsules every 6 hours for 10 days). The majority of these patients were naive (64%), with an average age of 50 years, 64% women and 16% with peptic ulcer. An overall modified intention-to-treat effectiveness of 92% was achieved. Eradication was over 90% in first-line treatment (95% modified intention-to-treat, n = 1166), and this was maintained as a rescue therapy, both in second (89% modified intention-to-treat, n = 375) and subsequent lines of therapy (third to sixth line: 92% modified intention-to-treat, n = 236). Compliance was the factor most closely associated with treatment effectiveness. Adverse events were generally mild to moderate, and 3% of patients reported a severe adverse event, leading to discontinuation of treatment in 1.7% of cases. Conclusions Single-capsule bismuth quadruple therapy achieved H. pylori eradication in approximately 90% of patients in real-world clinical practice, both as a first-line and rescue treatment, with good compliance and a favourable safety profile.

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