Effect of Green Tea Extract and Soy Isoflavones on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Weiwei Zeng; Miao Hu; Hon Kit Lee; Elaine Wat; Clara Bik San Lau; Chung Shun Ho; Chun Kwok Wong; Brian Tomlinson

doi:10.3389/fnut.2022.850318

Effect of Green Tea Extract and Soy Isoflavones on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Front Nutr. 2022 Mar 24:9:850318. doi: 10.3389/fnut.2022.850318. eCollection 2022.

Authors

Weiwei Zeng¹, Miao Hu², Hon Kit Lee^{3

4}, Elaine Wat⁵, Clara Bik San Lau⁵, Chung Shun Ho³, Chun Kwok Wong^{3

5}, Brian Tomlinson^{2

6}

Affiliations

¹ Shenzhen Baoan Women's and Children's Hospital, Jinan University, Shenzhen, China.
² Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Hong Kong SAR, China.
³ Department of Chemical Pathology, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.
⁴ Department of Clinical Pathology, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.
⁵ Institute of Chinese Medicine and State Key Laboratory of Research on Bioactivities and Clinical Applications of Medicinal Plants, The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.
⁶ Faculty of Medicine, Macau University of Science and Technology, Macau, China.

Abstract

Background and aim: Green tea and soy products are extensively consumed in daily life. Research has shown that green tea catechins and soy isoflavones may influence the activity of drug metabolizing enzymes and drug transporters. We examined whether regular consumption of green tea extract or soy isoflavones affected the pharmacokinetics of a single dose of rosuvastatin in healthy subjects and whether any interactions were influenced by the polymorphism in the drug transporter ABCG2.

Study design: This was an open-label, three-phase randomized crossover study with single doses of rosuvastatin.

Methods: Healthy Chinese male subjects were given a single dose of rosuvastatin 10 mg on 3 occasions: 1. without herbs; 2. with green tea extract; 3. with soy isoflavone extract. The green tea and soy isoflavone extract were given at a dose containing EGCG 800 mg once daily or soy isoflavones-80 mg once daily for 14 days before statin dosing and at the same time as the statin dosing with at least 4-weeks washout period between phases.

Results: Twenty healthy male subjects completed the study and the intake of green tea extract significantly reduced the systemic exposure to rosuvastatin by about 20% reducing AUC_0-24h from [geometric mean (% coefficient of variation)] 108.7 (28.9) h·μg/L to 74.1 (35.3) h·μg/L and C_max from 13.1 (32.2) μg/L to 7.9 (38.3) μg/L (P < 0.001 for both), without affecting the elimination half-life. The ABCG2 421C>A polymorphism had a significant effect on rosuvastatin exposure but no impact on the interaction with green tea. Soy isoflavones had no significant effect on rosuvastatin pharmacokinetics.

Conclusion: This study showed that repeated administration of green tea extract significantly reduced the systemic exposure of rosuvastatin in healthy volunteers. These effects might be predicted to either reduce or increase the lipid-lowering effect of rosuvastatin depending on the mechanism of the effect.

Keywords: ABCG2; EGCG; drug interaction; green tea; rosuvastatin; soy isoflavones.