Bioequivalencia clínica de dos marcas de esomeprazol administradas en pacientes con ulcus gastroduodenal / Clinical bioequivalence of 2 brands of esomeprazol administered in patients with gastroduodenal ulcus

RESUMEN

Los inhibidores de bomba de protones son usados en el tratamiento de la gastropatía ácido-péptica. Objetivo: comparar la eficacia de dos marcas de esomeprazol en el tratamiento de gastropatía ácido-péptica, la evolución de síntomas y su tolerancia. Materiales y Métodos: Se incluyeron pacientes de ambos sexos, con edades entre 18-60 años, con o sin Helicobacter pylori, que en la gastroscopia presentaron una o más erosiones o úlceras ≥ 5 mm y < 25 mm en su diámetro mayor. Se distribuyeron aleatoriamente a recibir una de las marcas, 40 mg/día, oral, durante 4 semanas. Al final fueron evaluados con endoscopia, interrogatorio de efectos adversos y laboratorio, comparando tasa de curación y evolución de la endoscopia. Se evaluó la tasa de respondedores por disminución del score de síntomas y la tolerancia mediante interrogatorio de efectos adversos y pruebas de laboratorio. Resultados: Ingresaron 34 pacientes, analizando los resultados de 30. En ambos grupos observamos mejoría en la endoscopia (curación y/o mejoría). El score de síntomas mejoró en ambos grupos, con significancia intragrupo pero no intergrupal. Los efectos adversos no fueron significativos. Conclusiones: Observamos mejoría en los criterios de endoscopia, y en el score de síntomas, en ambos grupos.

ABSTRACT

Introduction: Proton pump inhibitors are used in the treatment of acid-peptic gastropathy. Objective: to compare the efficacy of two brands of esomeprazole in the treatment of acid-peptic gastropathy, the evolution of symptoms and their tolerance. Materials and methods: Patients of both sexes, aged 18-60 years, with or without Helicobacter pylori, who had one or more erosions or ulcers ≥ 5 mm and <25 mm in their largest diameter, in gastroscopy, were included. They were randomized to receive one of the brands, 40 mg / day, orally, for 4 weeks. At the end, they were evaluated with endoscopy, adverse event questioning and laboratory tests, comparing cure rate and evolution of endoscopy. We evaluated the rate of responders according to decreased symptom score, and tolerance through questioning of adverse effects and laboratory tests. Results: Thirty-four patients were enrolled, analyzing the results of 30 patients. In both groups we observed improvement in endoscopy (healing and / or improvement). The score of symptoms improved in both groups, with intragroup but not intergroup significance. Adverse events were not significant. Conclusions: Thirty-four patients were enrolled, analyzing the results of 30 patients. In both groups we observed improvement in endoscopy (healing and / or improvement). The score of symptoms improved in both groups, with intragroup but not intergroup significance. Adverse events were not significant.