Systemic pharmacokinetics of indacaterol, an inhaled once-daily long-acting β2-agonist, in different ethnic populations
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Matsushima, Soichiro, Matthews, Ivan, Woessner, Ralph, Pinault, Gregory, Hara, Hisanori, 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 |