Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Caldas M

PROVIDER: S-EPMC7823881 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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

Caldas María M Pérez-Aisa Ángeles Á Castro-Fernández Manuel M Bujanda Luis L Lucendo Alfredo J AJ Rodrigo Luis L Huguet Jose M JM Pérez-Lasala Jorge J Molina-Infante Javier J Barrio Jesús J Fernández-Salazar Luis L Lanas Ángel Á Perona Mónica M Domínguez-Cajal Manuel M Ortuño Juan J Gómez-Rodríguez Blas José BJ Almela Pedro P Botargués Josep María JM Núñez Óscar Ó Modolell Inés I Gómez Judith J Ruiz-Zorrilla Rafael R De la Coba Cristóbal C Huerta Alain A Iyo Eduardo E Pozzati Liliana L Antón Rosario R Barenys Mercé M Angueira Teresa T Fernández-Bermejo Miguel M Campillo Ana A Alcedo Javier J Pajares-Villaroya Ramón R Mego Marianela M Bermejo Fernando F Dominguez-Jiménez José Luis JL Titó Llúcia L Fernández Nuria N Pabón-Carrasco Manuel M Cosme Ángel Á Mata-Romero Pilar P Alcaide Noelia N Ariño Inés I Di Maira Tommaso T Garre Ana A Puig Ignasi I Nyssen Olga P OP Megraud Francis F O'Morain Colm C Gisbert Javier P JP

Antibiotics (Basel, Switzerland) 20201225 1

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 develope ...[more]

PMID: 33375717

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Project description:BackgroundThere 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.ObjectiveTo evaluate the effectiveness and safety of the single-capsule bismuth quadruple therapy.MethodsData 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 Gastroenterologia 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.ResultsFinally, 2100 patients were prescribed single-capsule bismuth quadruple therapy following the technical sheet (i.e., three capsules every 6 h 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.ConclusionsSingle-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.

Project description:Summary of Trial Design.Lengthy exposure to quinolone-containing triple therapy in Helicobacter pylori eradication leads to the development of drug resistance. Sequential therapy with a quinolone and metronidazole -containing regimen appears to be an effective treatment option. This randomized controlled trial aimed to compare the efficacy of 5-plus 5 days' levofloxacin and metronidazole-containing sequential therapy (EALM) with that of 10-day levofloxacin-containing triple therapy (EAL) in second-line H pylori eradication treatment.One hundred and sixty-four patients who had failed the H pylori eradication attempts using the standard triple therapy (proton pump inhibitor bid, clarithromycin 500?mg bid, amoxicillin 1?g bid?×?7 days) were randomly assigned to either an EALM therapy group (n?=?82; esomeprazole 40?mg bid and amoxicillin 1?g bid for 5 days, followed by esomeprazole 40?mg bid, levofloxacin 500?mg qd, and metronidazole 500?mg tid, for 5 days) or a 10-day EAL therapy group (n?=?82; levofloxacin 500?mg qd, amoxicillin 1?g bid, and esomeprazole 40?mg bid). One patient was lost to follow-up in each group. Follow-up for H pylori status was performed 4 to 8 weeks later.Eradication rates for the EALM and EAL groups were 90.2% (74/82, 95% confidence interval [CI]?=?83.7%-96.8%) and 80.5% (66/82, 95% CI?=?71.7%-89.2%, P?=?0.077) in the intention-to-treat analysis; and 91.4% (74/81, 95% CI?=?85.1%-97.6%) and 81.5% (66/81, 95% CI?=?72.8%-90.1%, P?=?0.067) in the per-protocol analysis. The adverse events for the EALM and EAL groups were 23.5% versus 11.1%, P?=?0.038 but were all very mild and were well tolerated except for 1 patient with poor compliance. The compliances were 98.8% and 100%, respectively, between the 2 groups. An antibiotic resistance to levofloxacin was the clinical factor influencing the efficacy of H. pylori eradication therapy in the EAL group, and dual resistance to levofloxacin and metronidazole in the EALM group.Levofloxacin and metronidazole-containing sequential therapy achieved a >90% eradication rate as a second-line H pylori therapy. Dual antibiotic resistance to levofloxacin and metronidazole was the clinical factor influencing the efficacy of H pylori eradication therapy in the sequential therapy (ClinicalTrials.gov number: NCT02596620).

Project description:BACKGROUND AND AIM: Helicobacter pylori eradication clearly decreases peptic ulcer recurrence rates. H. pylori eradication is achieved in 70-90% of cases, but treatment failures due to poor patient compliance and resistant organisms do occur. Lactobacillus gasseri can suppress both clarithromycin-susceptible and -resistant strains of H. pylori in vitro. The aim of this study was to determine the effect of pretreatment with L. gasseri- containing yogurt on H. pylori eradication. We conducted a randomized, controlled clinical trial in patients with H. pylori infection. METHODS: A total of 229 patients were randomized into either a 1-week triple therapy of rabeprazole (10 mg bid), amoxicillin (750 mg bid), and clarithromycin (200 mg bid) or triple therapy plus L. gasseri-containing yogurt. In the yogurt-plus-triple therapy groups, yogurt containing L. gasseri OLL2716 (112 g) was given twice daily for 4 weeks (3 weeks pretreatment and also 1 week during eradication therapy). Clarithromycin resistance was determined by the detection of a mutation in 23S rRNA using nested polymerase chain reaction and the direct sequencing of DNA from pretreatment feces. H. pylori eradication was diagnosed based on the urea breath test and a stool antigen test after 8 weeks of eradication. RESULTS: The status of H. pylori susceptibility to clarithromycin was successively determined in 188 out of 229 samples. The rate of infection with clarithromycin-resistant strains of H. pylori was 27.1%. Overall eradication (intention to treat/per protocol) was 69.3/74.5% for the triple-only group, and 82.6/85.6% for the yogurt-plus-triple group (P = 0.018/P = 0.041). Eradication of primary clarithromycin-resistant strains tended to be higher for yogurt-plus-triple therapy than triple-only therapy (38.5 vs 28.0%, respectively, P = 0.458). CONCLUSION: This study confirmed that the major cause of treatment failure is resistance to clarithromycin. A 4-week treatment with L. gasseri-containing yogurt improves the efficacy of triple therapy in patients with H. pylori infection.

Dataset Information

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

Publications

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

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