Evaluation of Morbidity Variances Amongst Randomized Non-Alcoholic Steatohepatitis (NASH) Subjects in a Large Clinical Research Center
Mentor Information
Guy W. Neff (Department of Hepatology)
Description
Introduction: NAFLD is a disease state which has grown into a silent pandemic and presents a challenge in patient identification. Non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) are subtypes of NAFLD with the latter subtype presenting inflammation and fibrosis. To elucidate the morbidity variances amongst NASH patients, a multivariate analysis on a cohort of liver biopsy confirmed NASH patients randomized in stage 2 and 3 clinical trials were assessed. The aim of this project is to identify a more accurate screening criteria based on co-morbidities associated with NASH. Methods: A retrospective analysis was completed including 68 randomized subjects withing NASH studies, that received liver biopsy confirmation. Data includes the following: metabolic risk factors such as diabetes, hypertension and obesity, controlled attenuation parameter (CAP) scores, stiffness score measured in kPa, average transaminase values, and average MRI-PDFF values. Results: Results from the retrospective analysis show that patients with three metabolic risk factors, such as diabetes, hypertension, and obesity result in higher rates of randomization into NASH trials (see table 1). Conclusion: The data above demonstrates obesity is a key factor in higher rates of randomization into NASH trials based on this subset of patients. Further in-depth analysis is needed to delineate the morbidities that identify the NASH population.
Evaluation of Morbidity Variances Amongst Randomized Non-Alcoholic Steatohepatitis (NASH) Subjects in a Large Clinical Research Center
Introduction: NAFLD is a disease state which has grown into a silent pandemic and presents a challenge in patient identification. Non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) are subtypes of NAFLD with the latter subtype presenting inflammation and fibrosis. To elucidate the morbidity variances amongst NASH patients, a multivariate analysis on a cohort of liver biopsy confirmed NASH patients randomized in stage 2 and 3 clinical trials were assessed. The aim of this project is to identify a more accurate screening criteria based on co-morbidities associated with NASH. Methods: A retrospective analysis was completed including 68 randomized subjects withing NASH studies, that received liver biopsy confirmation. Data includes the following: metabolic risk factors such as diabetes, hypertension and obesity, controlled attenuation parameter (CAP) scores, stiffness score measured in kPa, average transaminase values, and average MRI-PDFF values. Results: Results from the retrospective analysis show that patients with three metabolic risk factors, such as diabetes, hypertension, and obesity result in higher rates of randomization into NASH trials (see table 1). Conclusion: The data above demonstrates obesity is a key factor in higher rates of randomization into NASH trials based on this subset of patients. Further in-depth analysis is needed to delineate the morbidities that identify the NASH population.
