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Effects of Green Tea Extract on Atorvastatin Pharmacokinetics in Healthy Volunteers

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European Journal of Drug Metabolism and Pharmacokinetics Aims and scope Submit manuscript

A Letter to the Editor to this article was published on 16 April 2020

Abstract

Background and Objectives

Green tea catechins were recently reported to inhibit drug transporters such as organic anion-transporting polypeptides (OATPs) and metabolic enzymes, affecting the bioavailability of many drugs. This study aimed to evaluate the clinical significance of the effects of different doses of green tea extract on the pharmacokinetic parameters of atorvastatin and to rationalize the associated interaction mechanism.

Methods

A randomized, double-blind, three-phase crossover study involving 12 healthy volunteers was performed. Participants received a single dose of atorvastatin 40 mg alone (control group), atorvastatin 40 mg plus a capsule containing 300 mg of dry green tea extract, or atorvastatin 40 mg plus a capsule containing 600 mg of dry green tea extract. Plasma samples taken from the volunteers were analyzed for atorvastatin using liquid chromatography–tandom mass spectrometry (LC/MS/MS).

Results

Compared to atorvastatin alone, the administration of 300 mg or 600 mg of the green tea extract along with atorvastatin decreased the peak plasma concentration (Cmax) of atorvastatin by 25% and 24%, respectively (P < 0.05), and the area under the plasma concentration–time curve (AUC0−∞) of atorvastatin by 24% and 22%, respectively (P < 0.05). Additionally, administration of 300 mg or 600 mg of the green tea extract increased the apparent oral clearance (CL/F) of atorvastatin by 31% and 29%, respectively. The time to Cmax (Tmax) and the elimination half-life (t1/2) of atorvastatin did not differ among the three phases. The effects of 600 mg of the green tea extract on the pharmacokinetic parameters of atorvastatin were not significantly different from the effects of 300 mg of the green tea extract.

Conclusion

Green tea extract decreases the absorption but not the elimination of atorvastatin, possibly by inhibiting OATP, albeit not in a dose-dependent manner. Coadministration of green tea extract with atorvastatin may necessitate the monitoring of the plasma concentration of atorvastatin in clinical practice.

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Acknowledgements

We thank the members of the Clinical Pharmacy Department and the Pharmaceutical Technology Research Center in the Faculty of Pharmacy, Tanta University, Egypt.

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Authors and Affiliations

  1. Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt

    Khaled S. Abdelkawy & Reham M. Abdelaziz

  2. Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh City, Egypt

    Ahmed M. Abdelmageed

  3. Pharmaceutical Technology Department, Faculty of Pharmacy, Menofia University, Menofia City, Egypt

    Ahmed M. Donia

  4. Clinical Pharmacy Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt

    Noha M. El-Khodary

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  1. Khaled S. Abdelkawy
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Correspondence to Noha M. El-Khodary.

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Funding

This work was supported and funded by the Pharmaceutical Technology Research Center in the Faculty of Pharmacy, Tanta University, Egypt.

Conflict of interest

Khaled Abdelkawy, Reham Abdelaziz, Ahmed Abdelmageed, Ahmed Donia, and Noha El-Khodary declare that they have no conflict of interest relating to the content of this article.

Ethical approval

The study protocol was approved by the ethics committee of Tanta University in accordance with the Declaration of Helsinki and its amendments.

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All subjects provided written informed consent before participation.

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Abdelkawy, K.S., Abdelaziz, R.M., Abdelmageed, A.M. et al. Effects of Green Tea Extract on Atorvastatin Pharmacokinetics in Healthy Volunteers. Eur J Drug Metab Pharmacokinet 45, 351–360 (2020). https://doi.org/10.1007/s13318-020-00608-6

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