Evidence map›Paper›PMID 28831752›Full record

Trial reportDrugs in R&D2017

Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial.

David J Webb, Blai Coll, Hiddo J L Heerspink, Dennis Andress, Yili Pritchett, John J Brennan, Mark Houser, Ricardo Correa-Rotter, Donald Kohan, Hirofumi Makino and 8 more

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

Trial report in Drugs in R&D, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 26% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Endothelin receptor antagonists for pulmonary arterial hypertension.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Trial
  4. Article
  5. Review
  6. 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

18 authors at 14 institutions in 9 countries.

David J WebbEdinburgh Hypertension Excellence Centre, Clinical Pharmacology Unit, University of Edinburgh, E3.22, QMRI, 47 Little France Crescent, Edinburgh, EH16 4TJ, Scotland, UK. D.J.Webb@ed.ac.uk.
Blai CollAbbVie, North Chicago, IL, USA.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Dennis AndressAbbVie, North Chicago, IL, USA.
Yili PritchettMedImmune, Gaithersburg, MD, USA.
John J BrennanAbbVie, North Chicago, IL, USA.
Mark HouserAbbVie, North Chicago, IL, USA.
Ricardo Correa-RotterNational Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico.
Donald KohanUniversity of Utah Health Sciences Center, Salt Lake City, UT, USA.
Hirofumi MakinoOkayama University Graduate School of Medicine, Okayama, Japan.
Vlado PerkovicThe University of Sydney, Sydney, NSW, Australia.
Giuseppe RemuzziAzienda Ospedaliera Papa Giovanni XXIII and IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Bergamo, Italy.
Sheldon W TobeSunnybrook Health Sciences Center, Toronto, ON, Canada.
Robert TotoUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Robert BuschThe Endocrine Group, New York, NY, USA.
Pablo PergolaRenal Associates, P.A., San Antonio, TX, USA.
Hans-Henrik ParvingUniversity Hospital of Copenhagen, Copenhagen, Denmark.
Dick de ZeeuwDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
AbbVie (United States) · USCopenhagen University Hospital · DKEndocrine Society · USInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXOkayama University · JPOspedale Papa Giovanni XXIII · ITRenal Associates P. A. · USSunnybrook Health Science Centre · CAThe University of Texas Southwestern Medical Center · USUniversity Medical Center Groningen · NLUniversity of Edinburgh · GBUniversity of Groningen · NLUniversity of Sydney · AUUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFluid retention is a common adverse event in patients who receive endothelin (ET) receptor antagonist therapy, including the highly selective ETA receptor antagonist, atrasentan.

objectiveWe performed longitudinal assessments of thoracic bioimpedance in patients with type 2 diabetes mellitus and nephropathy to determine whether a decrease in bioimpedance accurately reflected fluid retention during treatment with atrasentan. STUDY

designWe conducted a randomized, double-blind, placebo-controlled study in 48 patients with type 2 diabetes mellitus and nephropathy who were receiving stable doses of renin angiotensin system inhibitors and diuretics.

methodsPatients were randomized 1:1:1 to placebo, atrasentan 0.5 mg, or atrasentan 1.25 mg once daily for 8 weeks. Thoracic bioimpedance, vital signs, clinical exams, and serologies were taken at weeks 1, 2, 4, 6, and 8, with the exception of serum hemoglobin, which was not taken at week 1, and serum brain natriuretic peptide, which was only taken at baseline, week 4, and week 8.

resultsAlterations in bioimpedance were more often present in those who received atrasentan than in those who received placebo, though overall differences were not statistically significant. Transient declines in thoracic bioimpedance during the first 2 weeks of atrasentan exposure occurred before or during peak increases in body weight and hemodilution (decreased serum hemoglobin).

conclusionsWe conclude that thoracic bioimpedance did not reflect changes in weight gain or edema with atrasentan treatment in this study. However, the sample size was small, and it may be of interest to explore the use of thoracic bioimpedance in a larger population to understand its potential clinical use in monitoring fluid retention in patients with chronic kidney disease who receive ET receptor antagonists.

Indexed as

AgedAtrasentanDiabetes Mellitus, Type 2Diabetic NephropathiesDiureticsDose-Response Relationship, DrugDouble-Blind MethodEdemaElectric ImpedanceEndothelin Receptor AntagonistsFemaleHumansLongitudinal StudiesMaleMiddle AgedPyrrolidinesAtrasentanDiureticsEndothelin Receptor AntagonistsPyrrolidines

Identifiers

PMID28831752
PMCPMC5629141
OpenAlexW2749649169

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.