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Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management

JM. Huguet, L. Ferrer-Barceló, P. Suárez, S. Barcelo-Cerda, J. Sempere, IM. Saracino, G. Fiorini, D. Vaira, Á. Pérez-Aísa, L. Jonaitis, B. Tepes, M. Castro-Fernandez, M. Pabón-Carrasco, A. Keco-Huerga, I. Voynovan, AJ. Lucendo, Á. Lanas, SJ....

. 2024 ; 12 (6) : 691-704. [pub] 20240429

Language English Country England, Great Britain

Document type Journal Article

Grant support
10058099 UK Research and Innovation
101095359 HORIZON EUROPE European Innovation Council
101101252 European Union programme EU4Health
DIASORIN

BACKGROUND: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy. OBJECTIVE: To determine which factors influence compliance with treatment. METHODS: A systematic prospective non-interventional registry (Hp-EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG-REDCap e-CRF and were subjected to quality control. Modified intention-to-treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance. RESULTS: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non-compliance rate was higher in patients prescribed longer regimens (10-, 14-days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non-adherence was lower for first-line treatment than for rescue treatment (1.5% vs. 2.2%; p < 0.001). Differences in non-adherence in the three most frequent first-line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non-compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2-7.7]; p < 0.001). CONCLUSIONS: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue-treatment, prolonged treatment regimens, the presence of adverse events, and the use of non-bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication.

Agencia Sanitaria Costa del Sol Red de Investigación en Servicios de Salud en Enfermedades Crónicas Marbella Spain

CIBER de enfermedades Hepáticas y Digestiva Madrid Spain

CIBERehd Zaragoza Spain

Cintesis Center for Research in Health Technologies and Information Systems Porto Portugal

Department of Applied Statistics and Operational Research and Quality Universitat Politècnica de Valencia Valencia Spain

Department of Digestive Disorders Aberdeen Royal Infirmary Aberdeen UK

Department of Gastroenterology A S Loginov Moscow Clinical Scientific Center Moscow Russia

Department of Gastroenterology AM DC Rogaska Rogaska Slatina Slovenia

Department of Gastroenterology and Hepatology Meander Medical Center Amersfoort Netherlands

Department of Gastroenterology CHRU de Nantes Hôpital Hôtel Dieu Nantes France

Department of Gastroenterology Clinical Center of Serbia University of Belgrade School of Medicine Belgrade Serbia

Department of Gastroenterology Digestive Diseases Centre Riga Latvia

Department of Gastroenterology Ferencváros Health Centre Budapest Hungary

Department of Gastroenterology Gastrocentr Perm Russia

Department of Gastroenterology Henry Dunant Hospital Athens Greece

Department of Gastroenterology Hepatology and Infectious Diseases Otto von Guericke University Hospital Magdeburg Germany

Department of Gastroenterology Hospital Clínic Barcelona Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas University of Barcelona Barcelona Spain

Department of Gastroenterology Hospital General de Tomelloso Tomelloso Spain

Department of Gastroenterology Hospital General Universitario de Valencia Valencia Spain

Department of Gastroenterology Lithuanian University of Health Sciences Kaunas Lithuania

Department of Gastroenterology Medical Microbiology Medical University of Sofia Sofia Bulgaria

Department of Gastroenterology Østfold Hospital Trust Grålum Norway

Department of Gastroenterology Pomeranian Medical University in Szczecin Szczecin Poland

Department of Gastroenterology University Hospital of Split University of Split School of Medicine Split Croatia

Department of Gastroenterology University of Oviedo Oviedo Spain

Department of Internal Medicine 2nd Faculty of Medicine Charles University Prague Czech Republic

Department of Outpatient Therapy and Family Medicine Tver State Medical University Tver Russia

Department of Pancreatic Biliary and Upper Digestive Tract Disorders A S Loginov Moscow Clinical Scientific Center Moscow Russia

Department of Propaedeutic of Internal Diseases and Gastroenterology A 1 Yevdokimov Moscow State University of Medicine and Dentistry Moscow Russia

Department of Therapy Azerbaijan State Advanced Training Institute for Doctors Named After Aziz Aliyev Baku Azerbaijan

Division for the Study of the Digestive Diseases and its Comorbidity with Noncommunicable Diseases Government Institution L T Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine Kharkiv Ukraine

Division of Gastroenterology and Hepatology Hacettepe University School of Medicine Ankara Turkey

Division of Gastroenterology Rabin Medical Center Petah Tikva Israel

Faculty of Health Sciences Trinity College Dublin Dublin Ireland

Gastroenterology Department Centro Hospitalar do Porto Instituto De Ciências Biomédicas de Abel Salazar Universidade do Porto Porto Portugal

Gastroklinik Private Gastroenterological Practice Horgen Switzerland

GOES Research Group Althaia Xarxa Assistencial Universitària de Manresa Manresa Spain

Hepatogastroenterology Department Institute for Clinical and Experimental Medicine Prague Czech Republic

Hospital Universitario de La Princesa Instituto de Investigación Sanitaria Princesa Madrid Spain

INSERM U1312 Université de Bordeaux Bordeaux France

Institute of Clinical and Preventive Medicine University of Latvia Riga Latvia

Instituto de Investigación Sanitaria de Aragón Zaragoza Spain

Instituto de Investigación Sanitaria de Castilla La Mancha Tomelloso Spain

Instituto de Investigación Sanitaria La Princesa Madrid Spain

IRCCS S Orsola Polyclinic University of Bologna Bologna Italy

Medical University Department Division of Gastroenterology and Hepatology Kantonsspital Aarau Aarau Switzerland

Medicina interna e Gastroenterologia Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy

Memorial Clinic Baku Azerbaijan

Sackler School of Medicine Tel Aviv University Tel Aviv Israel

Servicio de Aparato Digestivo Hospital Clínico Universitario Lozano Blesa Zaragoza Spain

The Centre for Digestive Diseases Endoklinika Szczecin Poland

Unidad de Aparato Digestivo Hospital Universitario de Valme Sevilla Spain

References provided by Crossref.org

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$a Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management / $c JM. Huguet, L. Ferrer-Barceló, P. Suárez, S. Barcelo-Cerda, J. Sempere, IM. Saracino, G. Fiorini, D. Vaira, Á. Pérez-Aísa, L. Jonaitis, B. Tepes, M. Castro-Fernandez, M. Pabón-Carrasco, A. Keco-Huerga, I. Voynovan, AJ. Lucendo, Á. Lanas, SJ. Martínez-Domínguez, E. Alfaro Almajano, L. Rodrigo, L. Vologzanina, DS. Bordin, A. Gasbarrini, G. Babayeva, F. Lerang, M. Leja, J. Kupčinskas, T. Rokkas, R. Marcos-Pinto, A. Meštrović, O. Gridnyev, PS. Phull, SM. Smith, D. Boltin, GM. Buzás, J. Kral, H. Şimşek, T. Matysiak-Budnik, V. Milivojevic, W. Marlicz, M. Venerito, L. Boyanova, M. Doulberis, LG. Capelle, A. Cano-Català, L. Moreira, OP. Nyssen, F. Mégraud, C. O'Morain, JP. Gisbert, Hp‐EuReg Investigators
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$a BACKGROUND: Adherence to Helicobacter pylori (H. pylori) eradication treatment is a cornerstone for achieving adequate treatment efficacy. OBJECTIVE: To determine which factors influence compliance with treatment. METHODS: A systematic prospective non-interventional registry (Hp-EuReg) of the clinical practice of European gastroenterologists. Compliance was considered adequate if ≥90% drug intake. Data were collected until September 2021 using the AEG-REDCap e-CRF and were subjected to quality control. Modified intention-to-treat analyses were performed. Multivariate analysis carried out the factors associated with the effectiveness of treatment and compliance. RESULTS: Compliance was inadequate in 646 (1.7%) of 38,698 patients. The non-compliance rate was higher in patients prescribed longer regimens (10-, 14-days) and rescue treatments, patients with uninvestigated dyspepsia/functional dyspepsia, and patients reporting adverse effects. Prevalence of non-adherence was lower for first-line treatment than for rescue treatment (1.5% vs. 2.2%; p < 0.001). Differences in non-adherence in the three most frequent first-line treatments were shown: 1.1% with proton pump inhibitor + clarithromycin + amoxicillin; 2.3% with proton pump inhibitor clarithromycin amoxicillin metronidazole; and 1.8% with bismuth quadruple therapy. These treatments were significantly more effective in compliant than in non-compliant patients: 86% versus 44%, 90% versus 71%, and 93% versus 64%, respectively (p < 0.001). In the multivariate analysis, the variable most significantly associated with higher effectiveness was adequate compliance (odds ratio, 6.3 [95%CI, 5.2-7.7]; p < 0.001). CONCLUSIONS: Compliance with Helicobacter pylori eradication treatment is very good. Factors associated with poor compliance include uninvestigated/functional dyspepsia, rescue-treatment, prolonged treatment regimens, the presence of adverse events, and the use of non-bismuth sequential and concomitant treatment. Adequate treatment compliance was the variable most closely associated with successful eradication.
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