European Registry on Helicobacter pylori management: Single-capsule bismuth quadruple therapy is effective in real-world clinical practice

Olga P Nyssen  1 , Angeles Perez-Aisa  2 , Manuel Castro-Fernandez  3 , Rinaldo Pellicano  4 , Jose M Huguet  5 , Luis Rodrigo  6 , Juan Ortuñ, O  7 , Blas J Gomez-Rodriguez  8 , Ricardo M Pinto  9   10 , Miguel Areia  10   11 , Monica Perona  12 , Oscar Nuñez  13 , Marco Romano  14 , Antonietta G Gravina  14 , Liliana Pozzati  15 , Miguel Fernandez-Bermejo  16 , Marino Venerito  17 , Peter Malfertheiner  17 , Luis Fernanadez-Salazar  18 , Antonio Gasbarrini  19 , Dino Vaira  20 , Ignasi Puig  21 , Francis Megraud  22 , Colm O'Morain  23 , Javier P Gisbert  1 , Hp-EuReg investigators

United European Gastroenterol J. 2021 Feb;9(1):38-46. doi: 10.1177/2050640620972615.

Abstract

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 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.

Results: Finally, 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.

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.

Trial registration: ClinicalTrials.gov NCT02328131.

Keywords: Helicobacter pylori; Pylera; bismuth; eradication; quadruple.