Evidence map›Paper›PMID 23407853›Full record

Trial reportEuropean journal of clinical pharmacology2013

Effect of ABCB1 polymorphisms and atorvastatin on sitagliptin pharmacokinetics in healthy volunteers.

Christina L Aquilante, Michael F Wempe, Maha S Sidhom, Lisa A Kosmiski, Julie A Predhomme

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. CommonTranslational and clinical pharmacology · 2022
    Article
  4. Article
  5. Pharmacogenetics of Type 2 Diabetes-Progress and Prospects.International journal of molecular sciences · 2020
    Review
  6. Review
  7. Review
  8. Patient profiling in diabetes and role of canagliflozin.Pharmacogenomics and personalized medicine · 2014
    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

5 authors at 2 institutions in 1 country.

Christina L AquilanteDepartment of Pharmaceutical Sciences, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, 12850 East Montview Boulevard, Mail Stop C238, Aurora, CO 80045, USA. Christina.aquilante@ucdenver.edu
Michael F Wempe
Maha S Sidhom
Lisa A Kosmiski
Julie A Predhomme
University of Montana · USUniversity of Colorado Denver · US

Funding

Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
The Role of P-glycoprotein in Sitagliptin Clinical PharmacologyR03DK084089 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI AQUILANTE, CHRISTINA L · 2009 to 2010
$152k
NCATS NIH HHS UL1 TR000154NCATS NIH HHS UL1TR000154NCATS NIH HHS UL1 TR001082NIDDK NIH HHS R03 DK084089
6 · The paper itself

Abstract

objectivesThe objectives of this study were to determine if ABCB1 polymorphisms are associated with interindividual variability in sitagliptin pharmacokinetics and if atorvastatin alters the pharmacokinetic disposition of sitagliptin in healthy volunteers.

methodsIn this open-label, randomized, two-phase crossover study, healthy volunteers were prospectively stratified according to ABCB1 1236/2677/3435 diplotype (n = 9, CGC/CGC; n = 10, CGC/TTT; n = 10, TTT/TTT). In one phase, participants received a single 100 mg dose of sitagliptin; in the other phase, participants received 40 mg of atorvastatin for 5 days, with a single 100 mg dose of sitagliptin administered on day 5. A 24-h pharmacokinetic study followed each sitagliptin dose, and the study phases were separated by a 14-day washout period.

resultsSitagliptin pharmacokinetic parameters did not differ significantly between ABCB1 CGC/CGC, CGC/TTT, and TTT/TTT diplotype groups during the monotherapy phase. Atorvastatin administration did not significantly affect sitagliptin pharmacokinetics, with geometric mean ratios (90 % confidence intervals) for sitagliptin maximum plasma concentration, plasma concentration-time curve from zero to infinity, renal clearance, and fraction of sitagliptin excreted unchanged in the urine of 0.93 (0.86-1.01), 0.96 (0.91-1.01), 1.02 (0.93-1.12), and 0.98 (0.90-1.06), respectively.

conclusionsABCB1 CGC/CGC, CGC/TTT, and TTT/TTT diplotypes did not influence sitagliptin pharmacokinetics in healthy volunteers. Furthermore, atorvastatin had no effect on the pharmacokinetics of sitagliptin in the setting of ABCB1 CGC/CGC, CGC/TTT, and TTT/TTT diplotypes.

Indexed as

Polymorphism, Single NucleotideAdultAtorvastatinATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1BiotransformationCohort StudiesColoradoCross-Over StudiesDipeptidyl-Peptidase IV InhibitorsDrug InteractionsFemaleGenetic Association StudiesHalf-LifeHeptanoic AcidsHumansABCB1 protein, humanAtorvastatinATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1Dipeptidyl-Peptidase IV InhibitorsHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPyrazinesPyrrolesSitagliptin PhosphateTriazoles

Identifiers

PMID23407853
PMCPMC3676426
OpenAlexW2018409137

What OpenQuestion holds

Textmetadata
LicenceTDM
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.