Evidence map›Paper›PMID 28345163›Full record

ArticleBritish journal of clinical pharmacology2017

Pharmacokinetics and safety of letermovir, a novel anti-human cytomegalovirus drug, in patients with renal impairment.

Dirk Kropeit, Jürgen Scheuenpflug, Katharina Erb-Zohar, Atef Halabi, Hans-Peter Stobernack, Ellen G J Hulskotte, Arne van Schanke, Holger Zimmermann, Helga Rübsamen-Schaeff

Abstract readClinical Trial, Phase I
In one paragraph

Article in British journal of clinical pharmacology, 2017. 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
–field-weighted citation impact
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.

  1. Trial
  2. Review
  3. Observational
  4. Cytomegalovirus prevention in thoracic organ transplantation: A single-center evaluation of letermovir prophylaxis.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2022
    Article
  5. Review
  6. Moving Past Ganciclovir and Foscarnet: Advances in CMV Therapy.Current hematologic malignancy reports · 2020
    Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. 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

9 authors.

Dirk KropeitAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
Jürgen ScheuenpflugAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
Katharina Erb-Zoharclinphase, Hanau, Germany.
Atef HalabiCRS Clinical Research Services Kiel GmbH, Kiel, Germany.
Hans-Peter StobernackAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
Ellen G J HulskotteMSD Netherlands, Oss, The Netherlands.
Arne van SchankeMSD BV, Oss, The Netherlands.
Holger ZimmermannAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
Helga Rübsamen-SchaeffAiCuris Anti-infective Cures GmbH, Wuppertal, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsHuman cytomegalovirus remains a significant issue for immunocompromised patients and existing viral polymerase targeting therapies are associated with significant toxicity. Accordingly, the viral terminase complex inhibitor, letermovir, is in development. We assessed letermovir pharmacokinetics in renal impairment.

methodsThis was a Phase 1, open-label, nonrandomised trial. Estimated glomerular filtration rate based on the Modification of Diet Renal Disease equation was used to create three groups of eight subjects: healthy function (estimated glomerular filtration rate ≥ 90 ml min

resultsAll 24 subjects enrolled completed the trial. Moderate and severe renal impairment increased mean unbound letermovir fractions by 11% and 26%, respectively, vs. healthy subjects. Exposure (AUC

conclusionsRenal impairment increased exposure to letermovir, although age was a confounding factor.

Indexed as

AcetatesAgedAntiviral AgentsFemaleGlomerular Filtration RateHumansMaleMiddle AgedQuinazolinesRenal InsufficiencyAcetatesAntiviral AgentsletermovirQuinazolinesantiviralscytomegalovirusletermovirpharmacokineticsrenal insufficiency

Identifiers

PMID28345163
PMCPMC5555856

What OpenQuestion holds

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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.