Un ensayo clínico piloto de la efectividad clínica de dos presentaciones de esomeprazol / Clinical effectiveness of two esomeprazole presentations in a pilot trial

Resumen Introducción: el presente estudio tuvo como fin investigar la efectividad clínica de dos presentaciones de esomeprazol en pacientes con dispepsia de causa no estudiada. Métodos: se realizó un ensayo clínico piloto de dos presentaciones de esomeprazol de 40 mg recibidos diariamente por 28 días. Se eligieron pacientes con diagnóstico de dispepsia no estudiada que asistieron a consulta de gastroenterología en un hospital de referencia. Se evaluaron a los pacientes inicialmente con endoscopia y biopsia, el seguimiento a 2 y 4 semanas con escalas clínicas de síntomas y calidad de vida con cuestionarios validados en español (SODA y QoL-PEI) y eventos adversos. Además, se midieron los niveles de pH gástrico con pH-metrías en 24 horas al día 14 de tratamiento. Se tomaron niveles séricos del medicamento al momento de la evaluación de la pH-metría. Para las escalas clínicas se aplicó un análisis de varianza (ANOVA) de dos factores con medidas repetidas y al encontrar diferencias significativas en los tiempos se realizó una corrección de Bonferroni. Resultados: se aleatorizó un total de 33 pacientes, 16 y 17 pacientes en cada grupo. No hubo diferencias en el porcentaje de inhibición del pH gástrico al día 14 de tratamiento (p = 0,9795). No hubo diferencias en concentraciones de niveles séricos el día 14 (p = 0,2199). No se encontraron diferencias significativas en las escalas de gravedad y calidad de vida en las dos primeras semanas de tratamiento, pero sí en las últimas dos semanas, en las cuales el producto de prueba demostró mayor disminución del dolor (p = 0,0048) y superioridad en conformidad (p = 0,01) en la subescala SODA. No se presentaron eventos adversos serios y no hubo diferencias estadísticas entre la presentación eventos adversos no serios. Conclusiones: los productos de prueba y el de referencia mostraron efectos similares en variables clínicamente relevantes.

Abstract Introduction: This pilot studied the clinical effectiveness of two presentations of esomeprazole in patients with dyspepsia with undiagnosed causes. Methods: We conducted a pilot clinical trial of two 40 mg Esomeprazole presentations. Patients with dyspepsia of unknown cause at a gastroenterology clinic in a referral hospital were included. They received one or the other presentation daily for 28 days. Patients were initially evaluated with endoscopy and biopsy and received follow-up examinations at two and four weeks. Adverse events were recorded, and clinical symptom scales and quality of life questionnaires validated in Spanish (SODA and QoL-PEI) were used. In addition, gastric pH levels were measured continuously for 24 hours on day 14 of treatment. Serum levels of the medication administered were also measured on day 14 of treatment. A two-way repeated measures ANOVA was used to compare mean differences between the two groups. When significant differences in times were found, a Bonferroni correction was made. Results: A total of 33 patients were randomized into two groups: 16 patients in one group and 17 in the other. There were no differences in the percentages of gastric pH inhibition at day 14 of treatment (p = 0.9795). There were no differences in serum level concentrations on day 14 (p = 0.2199). No significant differences were found in severity and quality of life scales in the first two weeks of treatment. However, in the last two weeks of treatment the test product showed a larger decrease in pain (p = 0.0048) and superiority in compliance (p = 0.01) on the SODA subscale. There were no serious adverse events, and there were no statistical differences between the presentations of non-serious adverse events. Conclusions: The Test product and the Reference product showed similar effects on clinically relevant variables.

Vitamin D binding protein, but not vitamin D or vitamin D-related peptides, is associated with septic shock mortality.

BACKGROUND: The aim of this study was to assess the prognostic value of vitamin D, vitamin D binding protein (VDBP) and vitamin D-related peptides in septic shock patients in relation to hospital mortality. METHODS: This is a single-center, prospective, observational study that included all consecutive patients meeting criteria for septic shock who were admitted to the ICU. VDBP, 25-hydroxy vitamin D, 1,25-dihydroxy vitamin D, cathelicidin and beta-defensin levels were determined in blood samples obtained on admission to the ICU. RESULTS: Seventy-five patients were studied. The best area under the curve (AUC) for prediction of in-hospital mortality was for VDBP (0.78), with a negative predictive value of 85.45% for the optimal cut-off point. VDBP was also the only variable that had a statistically significant association with a higher risk of in-hospital mortality, regardless of other assessed variables and pre-determined confounders: adjusted odds ratio of 5.20 (95% confidence interval: 1.21-22.36). When restricted to patients with vitamin D insufficiency (n=54), the AUC was 0.77, and the adjusted OR 12.22 (95% CI: 1.46-102.14; p=0.021) for in-hospital mortality. CONCLUSIONS: VDBP levels showed a statistically significant association with in-hospital mortality, supporting the clinical utility of VDBP as a good prognostic marker in septic shock patients. Vitamin D and vitamin D-related peptides are not associated with in-hospital mortality. These results should be confirmed in a multicentre study with a larger sample size.