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Inter‐individual variability in atrasentan exposure partly explains variability in kidney protection and fluid retention responses: a post‐hoc analysis of the SONAR trial

Diabetes, Obesity and Metabolism Nov 24, 2020

Koomen JV, Stevens J, Bakris G, et al. - Experts aspired to explore whether atrasentan plasma exposure explains between‐patient variability in urinary albumin‐to‐creatinine‐ratio (UACR) response, a surrogate for kidney protection, and B‐type natriuretic peptide (BNP) response, a surrogate for fluid expansion. In the active run-in period, type 2 diabetic patients with CKD (n = 4775) received 0.75 mg of atrasentan for six weeks. Using a population pharmacokinetic model, individual area under the concentration‐time‐curve (AUC) was estimated. Data reported that the median atrasentan AUC was 43.8 ng.h/mL with large variation among patients. Atrasentan plasma exposure differed among individual patients and partially explained between‐patient variability in effectiveness and safety response.

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