Evidence map›Paper›PMID 33135390›Full record

Trial reportPharmacology research & perspectives2020

Effect of gastric acid-reducing agents on the pharmacokinetics and efficacy of lemborexant.

Ishani Landry, Jagadeesh Aluri, Nancy Hall, Dinesh Kumar, Satish Dayal, Margaret Moline, Larisa Reyderman

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology research & perspectives, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

7 authors at 2 institutions in 2 countries.

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

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lemborexant is a dual orexin receptor antagonist approved for treating insomnia. As the solubility of lemborexant is pH-sensitive, the impact of the gastric acid-reducing agent (ARA), famotidine, on lemborexant pharmacokinetics was evaluated in a Phase 1 study. Additionally, post hoc analysis of data from Phase 3 studies examined the potential effect of concomitant ARAs on patient-reported/subjective sleep onset latency (sSOL) in subjects with insomnia. Coadministration of lemborexant 10 mg with famotidine decreased the maximum observed concentration by 27% and delayed time of maximum observed concentration by 0.5 hours. Famotidine did not affect overall lemborexant exposure based on comparison of area under the concentration curves. Concomitant ARA use in the Phase 3 studies did not impact the effect of lemborexant on sSOL; the change from baseline during the last 7 nights of 1 month of treatment with lemborexant 10 mg was -17.1 minutes with vs -17.9 minutes without ARAs. Collectively, these results indicate that lemborexant can be coadministered with ARAs.

Indexed as

AdultDouble-Blind MethodDrug InteractionsFamotidineFemaleGastric AcidHistamine H2 AntagonistsHumansMaleOrexin Receptor AntagonistsPyridinesPyrimidinesTreatment OutcomeFamotidineHistamine H2 AntagonistslemborexantOrexin Receptor AntagonistsPyridinesPyrimidinesgastric acidinsomnialemborexantorexin receptor antagonistspharmacokinetics

Identifiers

PMID33135390
PMCPMC7604696
OpenAlexW3097251067

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.