Systemic pharmacokinetics of indacaterol, an inhaled once-daily long-acting beta2-agonist, in different ethnic populations.
BACKGROUND
To assess ethnic sensitivity of indacaterol systemic pharmacokinetics in Japanese vs. non-Japanese patients.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Novartis Pharma KK, Minato-ku, Tokyo, Japan. soichiro.matsushima@novartis.com
Soichiro
S
Matsushima
Ivan
I
Matthews
Ralph
R
Woessner
Gregory
G
Pinault
Hisanori
H
Hara
Justin
J
Wilkins
Kaneo
K
Sekiguchi
D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000493:pharmacokinetics*; D044466:Asian People; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D015233:Models, Statistical; D015363:Quinolones / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D044465:White People
D058666:Adrenergic beta-2 Receptor Agonists; D003692:Delayed-Action Preparations; D007189:Indans; D015363:Quinolones; C510790:indacaterol