Evidence map›Paper›PMID 34062053›Full record

ArticleCPT: pharmacometrics & systems pharmacology2021

Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers.

Daryl J Fediuk, Kevin Sweeney, Vaishali Sahasrabudhe, Thomas McRae, Wonkyung Byon

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 55% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

5 authors at 1 institution in 1 country.

Daryl J FediukPfizer Inc, Groton, CT, USA.
Kevin SweeneyPfizer Inc, Groton, CT, USA.
Vaishali SahasrabudhePfizer Inc, Groton, CT, USA.
Thomas McRaePfizer Inc, New York, NY, USA.
Wonkyung ByonPfizer Inc, Groton, CT, USA.
Pfizer (United States) · US

Funding

Pfizer
6 · The paper itself

Abstract

Varenicline is an approved smoking cessation aid in adults. Population pharmacokinetics (popPK) and exposure-response (ER) (continuous abstinence rates [CAR] weeks 9-12 and nausea/vomiting incidence) for varenicline in adolescent smokers were characterized using data from two phase 1 and one phase 4 studies. A one-compartment popPK model with first-order absorption and elimination adequately fitted the observed data. The effect of female sex on apparent clearance was significant. Apparent volume of distribution increased with body weight and decreased by 24%, 15%, and 14% for black race, "other" race, and female sex, respectively. The observed range of exposure in the phase 4 study was consistent with that expected for each dose and body-weight group from the results obtained in adolescent PK studies, supporting that varenicline dose and administration were appropriate in the study. The relationship between CAR9-12 and varenicline area under the concentration-time curve (AUC) from 0 to 24 hours (AUC

Indexed as

Models, BiologicalSmokersAdolescentArea Under CurveChildClinical Trials, Phase I as TopicClinical Trials, Phase IV as TopicFemaleHumansMaleRacial GroupsRandomized Controlled Trials as TopicSex FactorsSmoking Cessation AgentsTissue DistributionVareniclineSmoking Cessation AgentsVarenicline

Identifiers

PMID34062053
PMCPMC8302239
OpenAlexW3165645136

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.