To investigate the efficacy and safety of Abexol and atorvastatin in patients with non-alcoholic fatty liver disease (NAFLD).Material and methods: The present study had a monocentric, randomized, ...double-blinded, comparative design with 4 parallel groups - group 1 (Abexol), group 2 (atorvastatin), group 3 (combined therapy) and group 4 (placebo) - to which dietary recommendations and physical activity practice were provided twice a day, for 24 weeks. Significant changes in the ultrasound analysis of the liver were considered a primary efficacy variable. Insulin resistance improvement (HOMA2-IR) was considered as a co-primary efficacy criterion. Significant changes in the serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), lipid profile variables and the anthropometric variables were evaluated as secondary variables of effectiveness. Statistical analysis of all data was according to the intention to treat method.
The groups were statistically homogeneous at baseline conditions. At the end of the 6 months of treatment about 50% of the patients in all groups showed a decrease of at least one degree in echogenicity, while the rest remained the same. There were no significant changes in the values of liver enzymes or anthropometric variables evaluated. Treatment with atorvastatin and combined therapy significantly reduced levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol. The treatments were safe and well tolerated, although in the atorvastatin group the number of adverse events reported was greater than in the rest of the groups.
Abexol and atorvastatin showed comparable efficacy and safety in patients with NAFLD, with advantages for treatment with atorvastatin with respect to its effects on the lipid profile of these patients.
Introducción: El Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) utiliza el software OpenClinica para diseñar los Cuadernos de Recogida de Datos (CRD) de los ensayos clínicos. Cada ensayo ...tiene características específicas, pero existen datos comunes a todos los ensayos que pueden ser estandarizados. Objetivo: Desarrollar una biblioteca de plantillas para el diseño de los CRD. Método: Se realizó un análisis documental de los estándares para el manejo de datos en los ensayos clínicos y se analizaron los diseños utilizados en cuatro ensayos desarrollados en OpenClinica. Resultados: Según los tipos de datos que se registran en los ensayos clínicos se diseñaron 14 plantillas. Cada plantilla, es un fichero Excel con cinco hojas de trabajo donde se registran todas las definiciones del CRD. Las plantillas se han utilizado en tres ensayos clínicos con resultados favorables. Conclusión: Las 14 plantillas que componen la biblioteca CRD fueron diseñadas permitiendo su futura reutilización en la gestión de datos de nuevos ensayos clínicos. Palabras clave: cuaderno de recogida de datos; manejo de datos; ensayo clínico; OpenClinica. Abstract Introduction: CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process. Objective: To develop a library of templates in order to design the CRF. Methods: A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed. Results: A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT. Conclusions: The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials. Keywords: case report forms; data management; clinical trial; OpenClinica.
PDF