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Systemic pharmacokinetics of indacaterol, an inhaled once-daily long-acting β2-agonist, in different ethnic populations

Matsushima, Soichiro and Matthews, Ivan and Woessner, Ralph and Pinault, Gregory and Hara, Hisanori and Wilkins, Justin and Sekiguchi, Kaneo (2012) Systemic pharmacokinetics of indacaterol, an inhaled once-daily long-acting β2-agonist, in different ethnic populations. International journal of clinical pharmacology and therapeutics, 50. pp. 545-556. ISSN 0946-1965

Abstract

Rationale: 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 (Cmax) and trough (Cmin) 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, Cmax (4,392 observations, 1,845 patients) and Cmin (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. Conclusion: 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.

Item Type: Article
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Keywords: Indacaterol, Population Pharmacokinetics, Ethnic sensitivity
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Date Deposited: 13 Oct 2015 13:14
Last Modified: 13 Oct 2015 13:14
URI: https://oak.novartis.com/id/eprint/8171

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