茚达特罗
药代动力学
医学
人口
内科学
支气管扩张剂
环境卫生
哮喘
作者
Shin Matsushima,Ivan Matthews,Ralph Woessner,Gregory Pinault,Hisanori Hara,Justin Wilkins,Kaneo Sekiguchi
出处
期刊:International Journal of Clinical Pharmacology and Therapeutics
[Dustri-Verlag Dr. Karl Feistle]
日期:2012-08-01
卷期号:50 (08): 545-556
被引量:7
摘要
To assess ethnic sensitivity of indacaterol systemic pharmacokinetics in Japanese vs. non-Japanese patients.Analyses were in three parts: data from a single "all Asian" clinical study; and two on pooled data - one using a linear mixed effects (LME) model and the other a non-linear mixed effects (NLME) model. The NLME model analyzed pharmacokinetic data from nine indacaterol studies; the LME model analyzed peak (C(max)) and trough (C(min)) serum concentration using data from four of these studies.In the all-Asian study, indacaterol serum concentration-time pharmacokinetic profiles in Japanese patients (n = 102) were similar to those in the overall population (n = 229). In the LME model, C(max) (4,392 observations, 1,845 patients) and C(min) (4,664 observations, 1,796 patients) for Japanese patients (n = 94) were on average 25% and 18% higher, respectively, than non-Japanese patients. However, after adjusting for study differences, this apparent ethnicity effect was not significant (p = 0.25 and 0.39, respectively). In the NLME model (25,540 observations, 2,857 patients), there was no statistically significant effect of Japanese (n = 230) ethnicity on indacaterol serum pharmacokinetics.No ethnicity effect was observed on indacaterol systemic pharmacokinetic profile for Japanese patients when compared with the overall Asian patient population or with the Caucasian patient population.
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