AI Article Synopsis

  • The study reanalyzed pharmacokinetics (PK) data of meloxicam in East Asian populations using previously published results from 119 healthy male subjects, including Japanese, Chinese, Korean, and white participants.
  • Key findings indicated that CYP2C9 genotype and lean body mass significantly influenced meloxicam clearance and volume of distribution, but no notable PK differences were found between the ethnic groups.
  • Moreover, simulations revealed that CYP2C9 genotype impacts the drug's pharmacodynamics (PD), suggesting that these genetic factors should be considered in clinical trials for East Asians with similar genetic profiles.

Article Abstract

We aimed to reanalyze the differences in the pharmacokinetics (PKs) of meloxicam in East Asian populations based on a population approach using previously published data and to investigate the factors found in population PK analysis that affect the pharmacodynamics (PDs) of meloxicam. Population PK analysis was performed in 119 healthy male subjects (30 Japanese, 30 Chinese, 29 Korean, and 30 white) under strictly controlled trial conditions with regulated meals and a single lot of the drug. We found that CYP2C9 genotype and lean body mass were statistically significant predictors of clearance and volume of distribution, respectively. A statistical significant difference in the PK parameters between ethnic groups could not be identified. Simulations using PK/PD models showed that CYP2C9 genotype is the factor that affects the PDs of meloxicam. The genetic polymorphisms highlighted in this study would be beneficial for conducting clinical trials in East Asians with similar genetic backgrounds.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5744175PMC
http://dx.doi.org/10.1002/psp4.12259DOI Listing

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