Evidence map›Paper›PMID 24995851›Full record

ArticleBritish journal of clinical pharmacology2014

Modified renal function in pregnancy: impact on emtricitabine pharmacokinetics.

Elodie Valade, Jean-Marc Tréluyer, François Dabis, Elise Arrivé, Emmanuelle Pannier, Sihem Benaboud, Floris Fauchet, Naïm Bouazza, Frantz Foissac, Saïk Urien and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. p16CPT: pharmacometrics & systems pharmacology · 2017
    Trial
  3. Article
  4. Article
  5. Review
  6. Article
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 5 institutions in 1 country.

Elodie ValadeEA08, Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Unité de Recherche Clinique Paris Centre, AP-HP, Paris, France; DHU Risques et Grossesse, Paris, France.
Jean-Marc Tréluyer
François Dabis
Elise Arrivé
Emmanuelle Pannier
Sihem Benaboud
Floris Fauchet
Naïm Bouazza
Frantz Foissac
Saïk Urien
Déborah Hirt
Gouvernance, Risque, Environnement, Développement · FRInserm · FRUniversité de Bordeaux · FRSorbonne Paris Cité · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aims were to describe emtricitabine (FTC) pharmacokinetics in a large population of pregnant women during the different trimesters of pregnancy, and to explain FTC pharmacokinetic variability during pregnancy.

methodsFTC plasma concentrations were measured in 103 non-pregnant and 83 pregnant women, including women in the different trimesters of pregnancy and on the day of delivery. A total of 457 plasma concentrations were available for analysis. A population pharmacokinetic model was developed with Monolix 4.1.3.

resultsFTC pharmacokinetics was best described by a two compartment model. The effect of creatinine clearance on apparent elimination clearance (CL/F) was significant. CL/F in pregnant women was significantly higher compared with non-pregnant women (geometric mean 24.1 vs 20.5 l h(-1) , P < 0.001), reflecting a modified renal function. FTC daily exposures (AUC) during pregnancy were lower than AUC in non-pregnant women, regardless of the trimester of pregnancy. FTC AUC geometric means were 8.38 mg l(-1 ) h in the second trimester of pregnancy, 8.16 mg l(-1 ) h in the third trimester of pregnancy, 8.30 mg l(-1 ) h on the day of delivery and 9.77 mg l(-1 ) h in non-pregnant women. FTC concentrations 24 h after administration were lower in pregnant women compared with non-pregnant women (0.054 vs. 0.079 mg l(-1) , P < 0.001) but still above the inhibitory concentration 50%.

conclusionsFTC CL/F was increased by 18% during pregnancy, reflecting a modified renal function with 50% increase in estimated glomerular filtration rate. However, the impact of this modified renal function on FTC pharmacokinetics was not sufficiently large to consider dose adjustments during pregnancy.

Indexed as

Area Under CurveCreatinineDeoxycytidineEmtricitabineFemaleGlomerular Filtration RateHumansModels, BiologicalPregnancyCreatinineDeoxycytidineEmtricitabineemtricitabinepopulation pharmacokineticspregnancy

Identifiers

PMID24995851
PMCPMC4256626
OpenAlexW1528424535

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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.