Evidence map›Paper›PMID 26040405›Full record

Trial reportBritish journal of clinical pharmacology2015

Population pharmacokinetics of oseltamivir in non-pregnant and pregnant women.

Venkateswaran C Pillai, Kelong Han, Richard H Beigi, Gary D Hankins, Shannon Clark, Mary F Hebert, Thomas R Easterling, Anne Zajicek, Zhaoxia Ren, Steve N Caritis and 1 more

Open access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

12 citing papers in PubMed, 35 citations in OpenAlex.

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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

11 authors at 6 institutions in 1 country.

Venkateswaran C PillaiDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, PA.
Kelong HanClinical Pharmacology, Genentech, Inc, CA.
Richard H BeigiDepartment of Obstetrics, Gynecology and Reproductive Sciences, Magee-Women's Hospital, University of Pittsburgh Medical Center, PA.
Gary D HankinsDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, TX.
Shannon ClarkDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, TX.
Mary F HebertDepartment of Pharmacy and Obstetrics & Gynecology, University of Washington, WA.
Thomas R EasterlingDepartment of Pharmacy and Obstetrics & Gynecology, University of Washington, WA.
Anne ZajicekObstetric and Pediatric Pharmacology and Therapeutics Branch, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, MD, USA.
Zhaoxia RenObstetric and Pediatric Pharmacology and Therapeutics Branch, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, MD, USA.
Steve N CaritisDepartment of Obstetrics, Gynecology and Reproductive Sciences, Magee-Women's Hospital, University of Pittsburgh Medical Center, PA.
Raman VenkataramananDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, PA.
University of Pittsburgh · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USThe University of Texas Medical Branch at Galveston · USUniversity of Washington · USGenentechUniversity of Pittsburgh Medical Center · US

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Pregnancy and Drug Metabolizing Enzymes and TransportersU10HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2004 to 2014
$9.7M
UW Obstetric-Fetal Pharmacology Research UnitU10HD047892 · NICHD · UNIVERSITY OF WASHINGTON · PI EASTERLING, THOMAS R, HEBERT, MARY F · 2004 to 2014
$9.4M
Obstetric Pharmacology Research Units Network Center at UTMB-GalvestonU10HD047891 · NICHD · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI AHMED, MAHMOUD S, HANKINS, GARY D · 2004 to 2014
$9.3M
NCATS NIH HHS UL1 TR000005NICHD NIH HHS 3U10 HD047891-05S2NICHD NIH HHS 5U10 HD 047905NICHD NIH HHS U10 HD047892
6 · The paper itself

Abstract

aimsPhysiological changes in pregnancy are expected to alter the pharmacokinetics of various drugs. The objective of this study was to evaluate systematically the pharmacokinetics of oseltamivir (OS), a drug used in the treatment of influenza during pregnancy.

methodsA multicentre steady-state pharmacokinetic study of OS was performed in 35 non-pregnant and 29 pregnant women. Plasma concentration-time profiles were analyzed using both non-compartmental and population pharmacokinetic modelling (pop PK) and simulation approaches. A one compartment population pharmacokinetic model with first order absorption and elimination adequately described the pharmacokinetics of OS.

resultsThe systemic exposure of oseltamivir carboxylate (OC, active metabolite of OS) was reduced approximately 30 (19-36)% (P < 0.001) in pregnant women. Pregnancy significantly (P < 0.001) influenced the clearance (CL/F) and volume of distribution (V/F) of OC. Both non-compartmental and population pharmacokinetic approaches documented approximately 45 (23-62)% increase in clearance (CL/F) of OC during pregnancy.

conclusionBased on the decrease in exposure of the active metabolite, the currently recommended doses of OS may need to be increased modestly in pregnant women in order to achieve comparable exposure with that of non-pregnant women.

Indexed as

AdolescentAdultAntiviral AgentsComputer SimulationFemaleHumansMiddle AgedModels, BiologicalOseltamivirPregnancyYoung AdultAntiviral AgentsOseltamiviroseltamivir carboxylateoseltamivirpopulation pharmacokineticspregnancy

Identifiers

PMID26040405
PMCPMC4631177
OpenAlexW2116875218

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.