Year 2019 / Volume 111 / Number 6
Original
Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients

467-470

DOI: 10.17235/reed.2019.5950/2018

Manuel Castro Fernández, Teresa Romero García, Alma Keco Huerga, Manuel Pabón Jaén, Eloísa Lamas Rojas, Rocío Llorca Fernández, Lourdes Grande Santamaría, María Rojas Feria,

Abstract
Introduction and objectives: quadruple therapy with bismuth is recommended as a first line treatment for Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the compliance, adverse effects and effectiveness of this treatment with the new galenic three-in-one capsule formulation containing bismuth subcitrate, metronidazole and tetracycline (Pylera®). Methods: a prospective, non-controlled, single center observational study was performed in a cohort of 200 consecutive patients with an untreated H. pylori infection; 58% were female. The subjects were treated for ten days with Pylera® of three capsules four times daily with meals and a proton pump inhibitor taken before breakfast and dinner. The Pylera® capsule contains 140 mg of bismuth subcitrate, 125 mg of metronidazole and 125 mg of tetracycline. The compliance and adverse effects of the treatment were evaluated via telephone contact and via an interview during the clinical revision. Eradication of infection was controlled for at least four weeks after treatment termination via the urea breath test, the stool antigen test with monoclonal antibodies or by histology. Results: treatment compliance was observed in 96% (192/200) of the patients. Only 28.5% (57/200) of the patients experienced adverse effects, which led to abandoning the treatment in only seven subjects. Severe adverse effects developed in only one case due to Clostridium difficile infection. The effectiveness based on intention to treat was 91.5% (183/200, 95% CI: 87.1-96.8) and per protocol was 95.2% (182/191, 95% CI: 90.9-98.9). Conclusions: in our experience, Pylera® is an effective and safe treatment that should be considered as a first line therapeutic option for the eradication of H. pylori infection.
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References
1.-Pajares JM, Gisbert JP. Helicobacter pylori: its discovery and relevance for medicine. Rev Esp Enferm Dig. 2006; 98: 770-85.
2.- Kandulsky A, Selgrad M, Malfertheiner P. Helicobacter pylori infection: A clinical overview. Dig Liver Dis. 2008 Aug;40(8):619-26. doi: 10.1016/j.dld.2008.02.026. .
3.- Correa P, Piazuelo MB. Natural History of Helicobacter pylori infection. Dig Liver Dis. 2008; 40(7): 490-6.
4.-IARC Helicobacter pylori Working Group (2014). Helicobacter pylori Eradication as a Strategy for Preventing Gastric Cancer. Lyin, France: International Agency for Research on cancer (IARC Working Group Reports, No 8).
5.-David Y. Graham. Helicobacter pylori update: Gastric Cancer, Reliable Therapy, and Possible Benefits. Gastroenterology. 2015; 148: 719-31.
6.-Megraud F, Bessede E, Varon C . Helicobacter pylori infection and gastric carcinoma, Clin Microbiol Infect. 2015 Nov;21(11):984-90. doi: 10.1016/j.cmi.2015.06.004.
7.- Gisbert JP ,Pajares R , Pajares JM. Evolution of Helicobacter pylori Therapy from a Meta-analytical Perspective. Helicobacter. 2007; 12: 50-8.
8.- Graham DY, Lee-Y-Ch, Wu M-S. Rational Helicobacter pylori therapy: evidence based medicine rather than medicine base evidence (revision 2). Clin Gastroenterol Hepatol 2014;12: 177-186.
9.-Molina-Infante , Shiotani A. et al. Practical Aspects in Choosing a Helicobacter pylori Therapy. Gastroenterol Clin. 2015; 44: 519-35.
10.-Gisbert JP,Calvet X, Gomollon F, et al. Tratamiento erradicador de Helicobacter Pylori.Recomendaciones de la II Conferencia Española de Consenso. Med Clin (Barc) 2005;125:301-16.
11.-Malfertheiner P, Megraud F, O´Mrain C, et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 2007;56: 772-781
12.-Gisbert JP, Calvet X , Bermejo F , et al. III Conferencia Española de Consenso sobre la infección por Helicobacter pylori. Gastroenterol Hepatol. 2013; 36: 340-74.
13.- Gisbert JP, Molina-Infante J, Amador J, et al. IV Conferencia Española de Consenso sobre el tratamiento de la infección por Helicobacter pylori. Gastroenterol Hepatol. 2016; 39: 697-721.
14.-Malfertheiner P, Megraud F, O’Morain CA, et al. Management of Helicobacter pylori infection—the Maastricht V/Florence Consensus Report. Gut. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288.
15.-Gomollón F, Ducóns JA , Gimeno L, et al. The Ideal Therapy Must Be Defined in Each Geographical Area: Experience with a Quadruple Therapy in Spain. Helicobacter. 1988; 3(2): 110-4.
16.-Gené E, Calvet X, Azagra R, et al. Triple vs. quadruple therapy for treating Helicobacter pylori infection: a meta-analysis. Aliment Pharmacol Ther. 2003; 17: 1137-43.
17.-Calvet X , Ducons J, Guardiola J, et al. One week triple vs. quadruple therapy for Helicobacter pylori infection-a randomized trial. Aliment Pharmacol Ther. 2002; 16: 1261-7.
18.-Graham DY, Lee S-Y. How to effectively use bismuth quadruple therapy: The good, the bad and the ugly. Gastroenterol Clin N Am 2015;44: 537-563.
19.-Malfertheiner P, Bazzoli F, Delchier JC, et al. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. Lancet. 2011; 377(9769): 905-13.
20.-.-De Francesco V, Pontone S, Bellesia A, et al. Quadruple, sequential, and concomitant first-line therapies for H.pylori eradication: a prospective, randomized study. Dig Liver Dis. 2017; 50(2): 139-41
21.- Gómez- Rodríguez BJ, Castro- Laria, Arguelles F, et al. A real life study of Helicobacter pylori eradication with bismuth quadruple therapy in naïve and previously treated patients. Rev Esp Enf Dig. 2017; 109(8): 552-8.
22.-Pérez-Arellano E, Rodriguez-Garcia MI et al. Eradication of Helicobacter pylori infection with a new bismuth-based quadruple therapy in clinical practice. Gastroenterol Hepatol. 2017; 41(3): 145-52.
23.-Agudo-Fernández S, González-Blanco A. Retrospective analysis of the use of quadruple therapy with bismuth (Pylera®) in real-life clinical practice in Spain.Gastroenterol Hepatol. 2018 Jul 2. pii: S0210-5705(18)30147-X. doi: 10.1016 /j.gastrohep. 2018.05.016.
24.-Tursi A, Di Mario F, Franceschi M, et al. . New bismuth-containing quadruple therapy in patients infected with Helicobacter pylori: A first Italian experience in clinical practice. Helicobacter. 2017 Jun;22(3). doi: 10.1111/hel.12371.
25.-Tursi A, Franceschi M, Allegretta L, et al. Effectiveness and safety of Pylera® in patients infected by Helicobacter Pylori. A multicenter, retrospective, real life study. Dig Dis 2018; 36:264-268.
26.-Fiorini G, Zullo A, Saracino IM, et al. Pylera and sequencial therapy for first-line Helicobacter pylori eradication: a cultura-based study in real clinical practice. Eur J Gastroenterol Hepatol 2018;30: 621-625.
27.-Zagari RM, Romiti A, Ierardi E, et al. The “three-in-one” formulation of bismuth quadruple therapy for Helicobacter pylori eradication with or without probiotics supplementation: Efficacy and safety in daily clinical practice. Helicobacter. 2018 Aug;23(4):e12502. doi: 10.1111/hel.12502.
28.-Miehlke S, Frederking D, Gunther T, et al. Efficacy of three-in-one capsule bismuth quadruple therapy for Helicobacter pylori eradication in clinical practice in a multinational patient population. Helicobacter. 2017 Dec;22(6). doi: 10.1111/hel.12429.
29.-McNicholl AG, Castro M, Pérez-Aisa A, et al. Registro europeo del manejo de H. pylori (HP-EuReg). Eficacia del tratamiento con Pylera® en más de 1000 pacientes. Gastroenterol Hepatol 2018;41 (Espec Congr 2):116.
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Castro Fernández M, Romero García T, Keco Huerga A, Pabón Jaén M, Lamas Rojas E, Llorca Fernández R, et all. Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients. 5950/2018


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Publication history

Received: 01/10/2018

Accepted: 12/11/2018

Online First: 22/05/2019

Published: 07/06/2019

Article revision time: 35 days

Article Online First time: 233 days

Article editing time: 249 days


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