Evidence map›Paper›PMID 31632000›Full record

ArticleInternational journal of chronic obstructive pulmonary disease2019

Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.

Marie T Borin, Arthur Lo, Chris N Barnes, Srikanth Pendyala, David L Bourdet

2 registry-linked trialsAbstract read
In one paragraph

Article in International journal of chronic obstructive pulmonary disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT02578082 phase1completednot on this map

The Effect of Severe Renal Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD 4208

TypeinterventionalSponsorMylan Inc.Ran2015 to 2016Enrolled16ConditionsRenal ImpairmentArmsTD-4208
NCT02581592 phase1completednot on this map

The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208

TypeinterventionalSponsorMylan Inc.Ran2015 to 2016Enrolled16ConditionsHepatic ImpairmentArmsTD-4208
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Revefenacin, a once-daily, long-acting muscarinic antagonist, for nebulized maintenance therapy in patients with chronic obstructive pulmonary disease.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2021
    Review
  3. Article
  4. Review
  5. 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

5 authors.

Marie T BorinDepartment of Clinical and Translational Pharmacology, Theravance Biopharma US, Inc., South San Francisco, CA, USA.ORCID 0000-0002-1561-4051
Arthur LoDepartment of Drug Metabolism and Pharmacokinetics, Theravance Biopharma US, Inc., South San Francisco, CA, USA.ORCID 0000-0001-7474-1328
Chris N BarnesDepartment of Biostatistics, Theravance Biopharma US, Inc., South San Francisco, CA, USA.
Srikanth PendyalaDepartment of Clinical Development, Inflammation and Immunology, Theravance Biopharma US, Inc., South San Francisco, CA, USA.
David L BourdetDepartment of Drug Metabolism and Pharmacokinetics, Theravance Biopharma US, Inc., South San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Revefenacin, a long-acting muscarinic antagonist for nebulization, has been shown to improve lung function in patients with chronic obstructive pulmonary disease. Here we report pharmacokinetic (PK) and safety results from two multicenter, open-label, single-dose trials evaluating revefenacin in subjects with severe renal impairment (NCT02578082) and moderate hepatic impairment (NCT02581592). Subjects and methods: The renal impairment trial enrolled subjects with normal renal function and severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m Results: In the renal impairment study, the maximum observed plasma revefenacin concentration (C Conclusion: Systemic exposure to revefenacin increased modestly in subjects with severe renal impairment but was similar between subjects with moderate hepatic impairment and normal hepatic function. The increase in plasma exposure to THRX-195518 in subjects with severe renal or moderate hepatic impairment is unlikely to be of clinical consequence given its low antimuscarinic potency, low systemic levels after inhaled revefenacin administration, and favorable safety profile.

Indexed as

AdolescentAdultAgedAged, 80 and overBenzamidesCarbamatesFemaleHepatic InsufficiencyHumansMaleMiddle AgedMulticenter Studies as TopicMuscarinic AntagonistsRenal InsufficiencySeverity of Illness IndexYoung AdultBenzamidesCarbamatesMuscarinic Antagonistsrevefenacinchronic obstructive pulmonary diseasekidney diseaseLAMAliver diseaselong-acting muscarinic antagonistrevefenacin

Identifiers

PMID31632000
PMCPMC6790214

What OpenQuestion holds

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Registered trials

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.