Evidence map›Paper›PMID 29368187›Full record

Trial reportEuropean journal of clinical pharmacology2018

Lack of pharmacokinetic interaction between fluvastatin and green tea in healthy volunteers.

Shingen Misaka, Osamu Abe, Hideyuki Sato, Tomoyuki Ono, Yayoi Shikama, Satomi Onoue, Hirooki Yabe, Junko Kimura

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Effects of Green Tea Extract on Atorvastatin Pharmacokinetics in Healthy Volunteers.European journal of drug metabolism and pharmacokinetics · 2020
    Trial
  4. Green Tea: Current Knowledge and Issues.Foods (Basel, Switzerland) · 2025
    Review
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Shingen MisakaDepartment of Pharmacology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 9601295, Japan. misaka@fmu.ac.jp.ORCID http://orcid.org/0000-0003-3426-6897
Osamu AbeDepartment of Pharmacology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 9601295, Japan.
Hideyuki SatoDepartment of Pharmacokinetics and Pharmacodynamics, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Tomoyuki OnoDepartment of Pharmacology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 9601295, Japan.
Yayoi ShikamaDepartment of Pharmacology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 9601295, Japan.
Satomi OnoueDepartment of Pharmacokinetics and Pharmacodynamics, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Hirooki YabeDepartment of Neuropsychiatry, Fukushima Medical University School of Medicine, Fukushima, Japan.
Junko KimuraDepartment of Pharmacology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 9601295, Japan.
Fukushima Medical University · JPUniversity of Shizuoka · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe objective of this study is to assess the effects of green tea and its major catechin component, (-)-epigallocatechin gallate (EGCG), on CYP2C9-mediated substrate metabolism in vitro, and the pharmacokinetics of fluvastatin in healthy volunteers.

methodsThe metabolism of diclofenac and fluvastatin in human recombinant CYP2C9 was investigated in the presence of EGCG. In a randomized three-phase crossover study, 11 healthy volunteers ingested a single 20-mg dose of fluvastatin with green tea extract (GTE), containing 150 mg of EGCG, along with water (300 mL), brewed green tea (300 mL), or water (300 mL) after overnight fasting. Plasma concentrations of fluvastatin and EGCG were measured by ultra-performance liquid chromatography with fluorescence detection and a single mass spectrometer.

resultsEGCG inhibited diclofenac 4'-hydroxylation and fluvastatin degradation with IC

conclusionsAlthough in vitro studies indicated that EGCG and brewed green tea produce significant inhibitory effects on CYP2C9 activity, the concomitant administration of green tea and fluvastatin in healthy volunteers did not influence the pharmacokinetics of fluvastatin.

Indexed as

TeaAdultAnti-Inflammatory Agents, Non-SteroidalCatechinCross-Over StudiesCytochrome P-450 CYP2C9DiclofenacFatty Acids, MonounsaturatedFemaleFluvastatinFood-Drug InteractionsHealthy VolunteersHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIndolesMaleAnti-Inflammatory Agents, Non-SteroidalCatechinCYP2C9 protein, humanCytochrome P-450 CYP2C9Diclofenacepigallocatechin gallateFatty Acids, MonounsaturatedFluvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsIndolesTeaCYP2C9Diclofenac(−)-Epigallocatechin gallateFluvastatinGreen teaPharmacokinetics

Identifiers

PMID29368187
OpenAlexW2785044372

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.