Evidence map›Paper›PMID 26423928›Full record

Trial reportEuropean journal of heart failure2015

Increased risk of stroke with darbepoetin alfa in anaemic heart failure patients with diabetes and chronic kidney disease.

Natalie A Bello, Eldrin F Lewis, Akshay S Desai, Inder S Anand, Henry Krum, John J V McMurray, Kurt Olson, Scott D Solomon, Karl Swedberg, Dirk J van Veldhuisen and 2 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 10% 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

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Interventions for fatigue in people with kidney failure requiring dialysis.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Trial
  5. Observational
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Diabetic vasculopathy: macro and microvascular injury.Current pathobiology reports · 2020
    Article
  14. Article
  15. Article
  16. Clinical Medicine Insights. Cardiology · 2018
    Article
  17. Improving Immunotherapy Through Glycodesign.Frontiers in immunology · 2018
    Review
  18. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 5 countries.

Natalie A BelloCardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Eldrin F LewisCardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Akshay S DesaiCardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Inder S AnandVA Medical Center and University of Minnesota, Minneapolis, MN, USA.
Henry KrumMonash University and the Alfred Hospital, Victoria, Australia.
John J V McMurrayBHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Kurt OlsonAmgen, Thousand Oaks, CA, USA.
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Karl SwedbergUniversity of Gothenburg, Gothenburg, Sweden.
Dirk J van VeldhuisenUniversity Medical Center Groningen, Groningen, The Netherlands.
James B YoungCleveland Clinic, Cleveland, OH, USA.
Marc A PfefferCardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Brigham and Women's Hospital · USAmgen (United States) · USCleveland Clinic · USMonash University · AUUniversity Medical Center Groningen · NLUniversity of Glasgow · GBUniversity of Gothenburg · SEUniversity of Minnesota · US

Funding

Training Program in Cardiovascular ResearchT32HL007374 · NHLBI · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI MITTLEMAN, MURRAY A · 1985 to 2019
$7.9M
NHLBI NIH HHS 5T32HL007374-34NHLBI NIH HHS T32 HL007374
6 · The paper itself

Abstract

aimsThe use of an erythropoesis-stimulating agent, darbepoetin alfa (DA), to treat anaemia in patients with diabetes mellitus and chronic kidney disease was associated with a heightened risk of stroke and neutral efficacy in the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), despite epidemiological data suggesting the contrary. However, this association has not been evaluated in another randomized, placebo-controlled trial. METHODS AND

resultsReduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) was a randomized placebo-controlled trial of DA in 2278 patients with systolic heart failure and anaemia, enrolled from 2006 to 2012 and followed for a median of 28 months. Within RED-HF, 816 patients had diabetes mellitus and chronic kidney disease [estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m(2) ] and met inclusion criteria for TREAT. TREAT-like RED-HF patient data were analysed alone and combined at the patient level with the 4038 TREAT patients. In RED-HF, the annualized event rate of stroke was 2.3 in patients on DA and 1.1 in patients randomized to placebo (P = 0.051). Analysis of the combined group (n = 4854) confirmed a nearly two-fold increase in stroke risk [hazard ratio (HR) 1.94, 95% confidence interval (CI) 1.43-2.63] and an overall neutral effect on mortality (HR 1.00, 95% CI 0.89-1.12) of raising haemoglobin with DA.

conclusionThe placebo-controlled cohort of heart failure patients with anaemia, diabetes mellitus, and chronic kidney disease from RED-HF provides confirmation of the increased stroke risk associated with DA use identified in TREAT.

Indexed as

AnemiaDarbepoetin alfaDiabetes Mellitus, Type 2Renal Insufficiency, ChronicStrokeAgedAged, 80 and overFemaleGlomerular Filtration RateHeart FailureHematinicsHumansMaleMiddle AgedOutcome Assessment, Health CareRisk AssessmentDarbepoetin alfaHematinicsAnaemiaDiabetes mellitusErythropoesis-stimulating agentHeart failureRenal dysfunctionStroke

Identifiers

PMID26423928
PMCPMC4703474
OpenAlexW2097676474

What OpenQuestion holds

Textmetadata
LicenceTDM
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.