Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of evolocumab between Caucasian and Asian populations.

ABSTRACT:

Aims

To evaluate the potential ethnic differences in the pharmacokinetics (PK) and pharmacodynamics (PD) of evolocumab in Caucasian and Asian populations using population PK/PD modelling analysis.

Methods

Data from different ethnic groups in 5 Phase I clinical trials, including two American studies, one Japanese study and two Chinese studies, were chosen for model building and evaluation. A target-mediated drug disposition model together with an indirect response model best captured evolocumab binding and the removal of unbound proprotein convertase subtilisin/kexin type 9 (PCSK9) as well as a reduction in circulating low-density lipoprotein cholesterol (LDL-C). Ethnicity and other related factors (body weight, target expression level etc.) were analysed as potential covaria

SUBMITTER: Wang C 

PROVIDER: S-EPMC6303218 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature