Effects of single green tea ingestion on pharmacokinetics of nadolol in healthy volunteers

Misaka, Shingen; Abe, Osamu; Ono, Tomoyuki; Ono, Yuko; Ogata, Hiroshi; Miura, Itaru; Shikama, Yayoi; Fromm, Martin F.; Shimomura, Kenju

doi:10.1111/bcp.14315

Cited by 15 publications

(19 citation statements)

References 17 publications

(47 reference statements)

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“…EGCG and other catechins have been reported to inhibit drug metabolism enzymes and transporters, such as cytochrome P450 (CYP), organic anion transporting polypeptides (OATPs), and P‐glycoprotein 8–12 . Moreover, previous studies by our group have demonstrated that green tea and EGCG‐concentrated green tea extract (GTE) significantly reduced plasma concentrations of a hydrophilic β‐blocker, nadolol, in humans, probably by inhibiting the intestinal absorption of nadolol 12–14 . These findings pose a hypothesis that the pharmacokinetics of hydrophilic cardiovascular drugs could be susceptible to green tea consumption.…”

Section: Methodsmentioning

confidence: 84%

“…[8][9][10][11][12] Moreover, previous studies by our group have demonstrated that green tea and EGCGconcentrated green tea extract (GTE) significantly reduced plasma concentrations of a hydrophilic β-blocker, nadolol, in humans, probably by inhibiting the intestinal absorption of nadolol. [12][13][14] These findings pose a hypothesis that the pharmacokinetics of hydrophilic cardiovascular drugs could be susceptible to green tea consumption.…”

Section: Lisinopril-green Tea Interactionmentioning

confidence: 85%

“…18 We designed this study based on our previous findings on nadolol-green tea interaction with respect to the following points: (i) EGCG would be a contributing factor to the interaction among various components of green tea, and (ii) single concomitant ingestion of GTE or green tea containing 300 mg of EGCG might be enough to cause the interaction. [12][13][14] The concentration of total catechins in a typical brewed green tea beverage has been reported to be 110-210 mg/100 mL, 19 and therefore a cup (200 mL) of green tea contains about 220-420 mg of catechins. Assuming that EGCG dose-dependently affects the lisinopril pharmacokinetics, as we observed in nadolol-EGCG interactions, 13 it is likely that EGCG at smaller doses contained in green tea products and supplements could substantially decrease the plasma concentrations of lisinopril in real-world settings.…”

Section: Discussionmentioning

confidence: 99%

“…However, due to high solubility, low membrane permeability, and poor metabolism, lisinopril is classified as a class 3 drug in both Biopharmaceutics Classification System and Biopharmaceutics Drug Disposition Classification System, which suggested that absorptive transporter effects may dominate the pharmacokinetics 18 . We designed this study based on our previous findings on nadolol–green tea interaction with respect to the following points: (i) EGCG would be a contributing factor to the interaction among various components of green tea, and (ii) single concomitant ingestion of GTE or green tea containing 300 mg of EGCG might be enough to cause the interaction 12–14 . The concentration of total catechins in a typical brewed green tea beverage has been reported to be 110–210 mg/100 mL, 19 and therefore a cup (200 mL) of green tea contains about 220–420 mg of catechins.…”

Section: Discussionmentioning

confidence: 99%

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Impact of Green Tea Catechin Ingestion on the Pharmacokinetics of Lisinopril in Healthy Volunteers

Misaka

Ono

Uchida

et al. 2020

Clinical Translational Sci

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Lisinopril, a highly hydrophilic long‐acting angiotensin‐converting enzyme inhibitor, is frequently prescribed for the treatment of hypertension and congestive heart failure. Green tea consumption may reduce the risk of cardiovascular outcomes and total mortality, whereas green tea or its catechin components has been reported to decrease plasma concentrations of a hydrophilic β blocker, nadolol, in humans. The aim of this study was to evaluate possible effects of green tea extract (GTE) on the lisinopril pharmacokinetics. In an open‐label, randomized, single‐center, 2‐phase crossover study, 10 healthy subjects ingested 200 mL of an aqueous solution of GTE containing ~ 300 mg of (–)‐epigallocatechin gallate, a major catechin component in green tea, or water (control) when receiving 10 mg of lisinopril after overnight fasting. The geometric mean ratio (GTE/control) for maximum plasma concentration and the area under the plasma concentration‐time curve of lisinopril were 0.289 (90% confidence interval (CI) 0.226–0.352) and 0.337 (90% CI 0.269–0.405), respectively. In contrast, there were no significant differences in time to reach maximum lisinopril concentration (6 hours in both phases) and renal clearance of lisinopril (57.7 mL/minute in control vs. 56.9 mL/minute in GTE). These results suggest that the extent of intestinal absorption of lisinopril was significantly impaired in the presence of GTE, whereas it had no major effect on the absorption rate and renal excretion of lisinopril. Concomitant use of lisinopril and green tea may decrease oral exposure to lisinopril, and therefore result in reduced therapeutic efficacy.

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Section: Methodsmentioning

confidence: 84%

Section: Lisinopril-green Tea Interactionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Impact of Green Tea Catechin Ingestion on the Pharmacokinetics of Lisinopril in Healthy Volunteers

Misaka

Ono

Uchida

et al. 2020

Clinical Translational Sci

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“…For this study, we reanalyzed the pharmacokinetic data of nadolol from 4 previously conducted studies in healthy Japanese volunteers. 11,13,18,19 The studies were registered in the UMIN Clinical Trials Registry under the code numbers UMIN000004221, UMIN000006064, UMIN000019398, and UMIN00 0019761. The study protocols were approved by the ethics committee of Fukushima Medical University.…”

Section: Clinical Datamentioning

confidence: 99%

Urinary Excretion of Nadolol as a Possible In Vivo Probe for Drug Interactions Involving P‐Glycoprotein

Shimazaki

Kuroda

Shimomura

et al. 2021

The Journal of Clinical Pharma

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Nadolol is a hydrophilic and nonselective β-adrenoceptor blocker with a bioavailability of 30%, relatively longer half-life, negligible metabolism, and predominant renal excretion. Previous studies have reported that nadolol is a substrate of P-glycoprotein, and the coadministration with itraconazole, a typical P-glycoprotein inhibitor,results in elevated plasma concentrations and cumulative urinary excretion of nadolol.In this study,we assessed whether measurements of urinary-excreted nadolol can be an alternative method of plasma pharmacokinetics for P-glycoprotein-mediated drug interactions in humans. We reanalyzed the pooled data set of plasma concentration and urinary excretion of nadolol from our previous clinical studies in a total of 32 healthy Japanese adults. The area under the plasma concentration-time curve from 0 to infinity (AUC 0-∞ ) of nadolol in individual subjects was significantly correlated with the maximum plasma concentration (r = 0.80, P < .01) and the cumulative amount excreted into urine (A e ) at 4 (r = 0.51, P = .01), 8 (r = 0.63, P < .01), 24 (r = 0.75, P < .01), and 48 (r = 0.77, P < .01) hours. Significant correlations were also observed between the AUC and A e during the same respective periods. In the drug interactions of nadolol with itraconazole, rifampicin, a well-known P-glycoprotein inducer, or grapefruit juice, there were significant correlations between the differences in AUC 0-48 and those in A e, 0-48 from the controls in individual subjects. These results suggest that the measurements of urinary excretion of nadolol can be employed as a sensitive and reliable alternative to plasma pharmacokinetics for the evaluation of P-glycoprotein-mediated drug interactions.

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Exposure of Fexofenadine, but Not Pseudoephedrine, Is Markedly Decreased by Green Tea Extract in Healthy Volunteers

Misaka

Ono

Taudte

et al. 2022

Clin Pharma and Therapeutics

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Green tea (GT) alters the disposition of a number of drugs, such as nadolol and lisinopril. However, it is unknown whether GT affects disposition of hydrophilic anti-allergic drugs. The purpose of this study was to investigate whether pharmacokinetics of fexofenadine and pseudoephedrine are affected by catechins, major GT components.A randomized, open, 2-phase crossover study was conducted in 10 healthy Japanese volunteers. After overnight fasting, subjects were simultaneously administered fexofenadine (60 mg) and pseudoephedrine (120 mg) with an aqueous solution of green tea extract (GTE) containing (−)-epigallocatechin gallate (EGCG) of ~ 300 mg or water (control). In vitro transport assays were performed using HEK293 cells stably expressing organic anion transporting polypeptide (OATP)1A2 to evaluate the inhibitory effect of EGCG on OATP1A2-mediated fexofenadine transport. In the GTE phase, the area under the plasma concentration-time curve and the amount excreted unchanged into urine for 24 hours of fexofenadine were significantly decreased by 70% (P < 0.001) and 67% (P < 0.001), respectively, compared with control. There were no differences in time to maximum plasma concentration and the elimination half-life of fexofenadine between phases. Fexofenadine was confirmed to be a substrate of OATP1A2, and EGCG (100 and 1,000 μM) and GTE (0.1 and 1 mg/mL) inhibited OATP1A2-mediated uptake of fexofenadine. On the contrary, the concomitant administration of GTE did not influence the pharmacokinetics of pseudoephedrine. These results suggest that intake of GT may result in a markedly reduced exposure of fexofenadine, but not of pseudoephedrine, putatively by inhibiting OATP1A2-mediated intestinal absorption.

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Effects of single green tea ingestion on pharmacokinetics of nadolol in healthy volunteers

Cited by 15 publications

References 17 publications

Impact of Green Tea Catechin Ingestion on the Pharmacokinetics of Lisinopril in Healthy Volunteers

Impact of Green Tea Catechin Ingestion on the Pharmacokinetics of Lisinopril in Healthy Volunteers

Urinary Excretion of Nadolol as a Possible In Vivo Probe for Drug Interactions Involving P‐Glycoprotein

Exposure of Fexofenadine, but Not Pseudoephedrine, Is Markedly Decreased by Green Tea Extract in Healthy Volunteers

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