Evidence map›Paper›PMID 31912603›Full record

Trial reportDiabetes, obesity & metabolism2020

Prediction and validation of exenatide risk marker effects on progression of renal disease: Insights from EXSCEL.

Nienke M A Idzerda, Lindsay E Clegg, Adrian F Hernandez, George Bakris, Robert C Penland, David W Boulton, M Angelyn Bethel, Rury R Holman, Hiddo J L Heerspink

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
1.7field-weighted citation impact, top 15% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Comparative Efficacy of Novel Antidiabetic Drugs on Albuminuria Outcomes in Type 2 Diabetes: A Systematic Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  7. Precision medicine approaches for diabetic kidney disease: opportunities and challenges.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
    Review
  8. Article
  9. Article
  10. 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 at 7 institutions in 7 countries.

Nienke M A IdzerdaDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.ORCID 0000-0001-6912-3429
Lindsay E CleggClinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, United States.ORCID 0000-0001-8558-9341
Adrian F HernandezDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States.
George BakrisUniversity of Chicago Medicine, Chicago, Illinois, United States.ORCID 0000-0003-1183-1267
Robert C PenlandClinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Waltham, Boston, Massachusetts, United States.ORCID 0000-0003-2706-8913
David W BoultonClinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, United States.
M Angelyn BethelDiabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Rury R HolmanDiabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.ORCID 0000-0002-1256-874X
Hiddo J L HeerspinkORCID 0000-0002-3126-3730
AstraZeneca (Poland) · PLUniversity of Oxford · GBAstraZeneca (South Korea) · KRDuke University · USHanze University of Applied Sciences · NLUniversity Medical Center Groningen · NLUniversity of Illinois Chicago · US

Funding

Amylin PharmaceuticalsAstraZenecaDuke Clinical Research InstituteEuropean Federation of Pharmaceutical Industries and AssociationsEuropean UnionEuropean Union Horizon 2020Horizon 2020Innovative Medicines Initiative BEAt-DKD programme (115974)Netherlands Organisation for Scientific ResearchNetherlands Organization for Scientific Research 917.15.306University of Oxford
6 · The paper itself

Abstract

aimTo assess whether the previously developed multivariable risk prediction framework (PRE score) could predict the renal effects observed in the EXSCEL cardiovascular outcomes trial using short-term changes in cardio-renal risk markers. MATERIALS AND

methodsChanges from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated. The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD). Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.

resultsCompared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria. The PRE score predicted a relative risk reduction for the 30% eGFR decline + ESRD endpoint of 11.3% (HR 0.89; 95% CI 0.83-0.94), compared with 12.7% (HR 0.87; 0.77-0.99) observed risk reduction. For the 40% eGFR decline + ESRD endpoint, the predicted and observed risk reductions were 11.0% (HR 0.89; 0.82-0.97) and 13.7% (HR 0.86, 0.72-1.04), respectively.

conclusionsIntegrating short-term risk marker changes into a multivariable risk score predicted the magnitude of renal risk reduction observed in EXSCEL.

Indexed as

Diabetes Mellitus, Type 2Kidney DiseasesAlbuminuriaDisease ProgressionExenatideGlomerular Filtration RateHumansRisk FactorsExenatidecardiovascular diseasediabetes complicationsexenatideglucagon-like peptide-1 analoguetype 2 diabetes

Identifiers

PMID31912603
PMCPMC7187441
OpenAlexW2999091434

What OpenQuestion holds

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LicenceCC BY-NC
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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.