Cumplimiento, efectos adversos y efectividad del tratamiento cuádruple con bismuto (Pylera(R)) como tratamiento erradicador de primera línea en 200 pacientes con infección por Helicobacter pylori / Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera(R)) to eradicate Helicobacter pylori infection in 200 patients

Introducción y objetivos: la cuádruple terapia con bismuto se recomienda como primera línea de tratamiento de la infección por Helicobacter pylori (H. pylori). El objetivo del estudio es valorar el cumplimiento, los efectos adversos y la efectividad de este tratamiento con la nueva forma galénica de cápsulas que contienen subcitrato de bismuto, metronidazol y tetraciclinas (Pylera(R)). Métodos: estudio observacional, prospectivo, unicéntrico, no controlado. Se incluyen 200 pacientes consecutivos, el 58% mujeres, con infección por H. pylori y sin tratamiento erradicador previo, tratados durante diez días con Pylera(R) (tres cápsulas cuatro veces al día con las comidas) asociado a un inhibidor de la bomba de protones antes de desayuno y cena. La cápsula de Pylera(R) contiene 140 mg de subcitrato de bismuto, 125 mg de metronidazol y 125 mg de tetraciclina. El cumplimiento y los efectos adversos del tratamiento se valoran mediante contacto telefónico y entrevista en la revisión clínica. El control de erradicación se realiza, al menos, tras cuatro semanas de finalizado el tratamiento, mediante la prueba del aliento con urea, la prueba de antígenos fecales con anticuerpos monoclonales o por histología. Resultados: a) cumplimiento del tratamiento en el 96% (192/200) de los pacientes; b) efectos adversos en el 28,5% (57/200) de los pacientes, motivando en siete casos el abandono del tratamiento y con gravedad en un solo caso por infección por Clostridium difficile; y c) efectividad por intención de tratamiento (183/200) del 91,5% (IC 95%: 87,1-96,8) y por protocolo (182/191) del 95,2% (IC 95%: 90,9-98,9). Conclusiones: el tratamiento con Pylera(R), en nuestra experiencia, es efectivo y seguro, debiéndose considerar como una opción terapéutica de primera línea en la erradicación de la infección por Helicobacter pylori

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(R)). 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(R) of three capsules four times daily with meals and a proton pump inhibitor taken before breakfast and dinner. The Pylera(R) 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(R) is an effective and safe treatment that should be considered as a first line therapeutic option for the eradication of H. pylori infection

Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients.

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.