Evidence map›Paper›PMID 33822479›Full record

ArticlePharmacology research & perspectives2021

Effect of hepatic impairment on pharmacokinetics, safety, and tolerability of lemborexant.

Satish Dayal, Jagadeesh Aluri, Nancy Hall, Gleb Filippov, Margaret Moline, Larisa Reyderman, Ishani Landry

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Pharmacology research & perspectives, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 46% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Orexin Receptor Antagonists and Insomnia.Current psychiatry reports · 2022
    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

7 authors at 2 institutions in 2 countries.

Satish DayalEisai Ltd., Hatfield, United Kingdom.
Jagadeesh AluriEisai Inc., Woodcliff Lake, NJ, USA.
Nancy HallEisai Inc., Woodcliff Lake, NJ, USA.
Gleb FilippovEisai Inc., Woodcliff Lake, NJ, USA.
Margaret MolineEisai Inc., Woodcliff Lake, NJ, USA.
Larisa ReydermanEisai Inc., Woodcliff Lake, NJ, USA.
Ishani LandryEisai Inc., Woodcliff Lake, NJ, USA.ORCID 0000-0002-4865-4754
Eisai (United States) · USEisai (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lemborexant, a dual orexin receptor antagonist, is approved in the United States, Japan, and Canada for the treatment of insomnia in adults. This phase I, multicenter, open-label, parallel-group study assessed the impact of mild or moderate hepatic impairment (HI) on lemborexant pharmacokinetics and metabolism. The pharmacokinetics, tolerability, and safety of lemborexant were evaluated in subjects with mild (Child-Pugh class A) or moderate (Child-Pugh class B) HI and healthy age-, sex-, and body mass index (BMI)-matched control subjects (n = 8 subjects/group). Subjects received a single oral dose of lemborexant 10 mg (LEM10). Blood samples were collected up to 312 hours post dosing for lemborexant pharmacokinetics assessments. Median time to maximum plasma concentration was similar across all groups. Compared with healthy subjects, exposure measures (maximum plasma concentration [C

Indexed as

Administration, OralAdolescentAdultAgedArea Under CurveFemaleHealthy VolunteersHepatic InsufficiencyHepatobiliary EliminationHumansMaleMiddle AgedPyridinesPyrimidinesSeverity of Illness IndexSleep Aids, PharmaceuticallemborexantPyridinesPyrimidinesSleep Aids, Pharmaceuticaldrug safetydual orexin receptor antagonisthepatic impairmentlemborexantpharmacokinetics

Identifiers

PMID33822479
PMCPMC8023329
OpenAlexW3147918177

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.