Role of compliance in Helicobacter pylori eradication treatment: Results of the European Registry on H. pylori management.
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Huguet Jose M, Ferrer-Barceló Luis, Suárez Patrícia, Barcelo-Cerda Susana, Sempere Javier, Saracino Ilaria Maria, Fiorini Giulia, Vaira Dino, Pérez-Aísa Ángeles, Jonaitis Laimas, Tepes Bojan, Castro-Fernandez M, Pabón-Carrasco Manuel, Keco-Huerga Alma, Voynovan Irina, Lucendo Alfredo J, Lanas Ángel, Martínez-Domínguez Samuel J, Alfaro Almajano Enrique, Rodrigo Luis, Vologzanina Ludmila, Bordin Dmitry S, Gasbarrini Antonio, Babayeva Gülüstan, Lerang Frode, Leja Mārcis, Kupčinskas Juozas, Rokkas Theodore, Marcos-Pinto Ricardo, Meštrović Antonio, Gridnyev Oleksiy, Phull Perminder S, Smith Sinead M, Boltin Doron, Buzás György Miklós, Kral Jan, Şimşek Halis, Matysiak-Budnik Tamara, Milivojevic Vladimir, Marlicz Wojciech, Venerito Marino, Boyanova Lyudmila, Doulberis Michael, Capelle Lisette G, Cano-Català Anna, Moreira Leticia, Nyssen Olga P, Mégraud Francis, O'Morain Colm, Gisbert Javier P, Hp‐EuReg Investigators
Аннотация
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.