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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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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