Evidence map›Paper›PMID 33587286›Full record

Trial reportClinical pharmacokinetics2021

Evaluation of the Pharmacokinetics and Exposure-Response Relationship of Dapagliflozin in Patients without Diabetes and with Chronic Kidney Disease.

Annemarie B van der Aart-van der Beek, Jeroen V Koomen, Claire C J Dekkers, Sean J Barbour, David W Boulton, Ron T Gansevoort, Peter J Greasley, Abdul Halim Abdul Gafor, Gozewijn D Laverman, Qiang Li and 8 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03190694 (A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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.

NCT03190694 phase2completednot on this map

A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial

TypeinterventionalSponsorHiddo Lambers HeerspinkRan2017 to 2019Enrolled53ConditionsChronic Kidney Diseases, ProteinuriaArmsDapagliflozin 10mg
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Bayesian Workflow for Minimal PBPK Models: Case Study of Dapagliflozin.CPT: pharmacometrics & systems pharmacology · 2026
    Article
  5. Article
  6. Article
  7. Review
  8. Review
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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 10 institutions in 6 countries.

Annemarie B van der Aart-van der Beek *Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.ORCID 0000-0003-1473-3259
Jeroen V Koomen *Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.
Claire C J DekkersClinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.
Sean J BarbourDivision of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
David W BoultonClinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.
Ron T GansevoortDepartment of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Peter J GreasleyEarly Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Abdul Halim Abdul GaforDepartment of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Gozewijn D LavermanDepartment of Internal Medicine, ZGT Hospital, Almelo and Hengelo, The Netherlands.
Qiang LiThe George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, NSW, Australia.
Soo Kun LimDivision of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Jasper StevensClinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands.
Marc G VervloetDepartment of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Sunita SinghDivision of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.
Daniel C CattranDivision of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.
Heather N ReichDivision of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.
David Z I CherneyDivision of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.
Hiddo J L HeerspinkClinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, PO Box 30 001, 9700 RB, Groningen, The Netherlands. h.j.lambers.heerspink@umcg.nl.
University Medical Center Groningen · NLUniversity Health Network · CAAmsterdam University Medical Centers · NLAstraZeneca (Sweden) · SEQuantitative BioSciences · USThe University of Sydney · AUUniversity Kebangsaan Malaysia Medical Centre · MYUniversity of British Columbia · CAUniversity of Malaya · MYZiekenhuis Groep Twente · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveDapagliflozin, a sodium-glucose co-transporter inhibitor, was originally developed as an oral glucose-lowering drug for the treatment of type 2 diabetes mellitus. Emerging data suggest that cardiovascular and kidney benefits extend to patients without diabetes. Limited pharmacological data are, however, available in patients without diabetes. We aimed to characterise the pharmacokinetic profile of dapagliflozin in patients with chronic kidney disease without type 2 diabetes.

methodsPlasma samples were collected in a randomised, placebo-controlled, double-blind, cross-over trial (DIAMOND, NCT03190694, n = 53) that assessed the effects of 10 mg of dapagliflozin in patients with a glomerular filtration rate ≥ 25 mL/min/1.73 m

resultsPlasma concentrations (n = 430 observations) from 48 patients (mean age 50.8 years, mean glomerular filtration rate 57.9 mL/min/1.73 m

conclusionsThe dapagliflozin plasma concentration-time profile in patients with non-diabetic kidney disease appears similar to the profile of patients with diabetic kidney disease described in the literature. Furthermore, the plasma exposure was associated with changes in risk markers for kidney disease.

Indexed as

Diabetes Mellitus, Type 2Renal Insufficiency, ChronicSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsGlomerular Filtration RateGlucosidesHumansMiddle AgedBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID33587286
PMCPMC8016788
OpenAlexW3132426811

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.