Evidence map›Paper›PMID 22210576›Full record

Trial reportDiabetes care2012

Benefits and safety of long-term fenofibrate therapy in people with type 2 diabetes and renal impairment: the FIELD Study.

Ru-Dee Ting, Anthony C Keech, Paul L Drury, Mark W Donoghoe, John Hedley, Alicia J Jenkins, Timothy M E Davis, Seppo Lehto, David Celermajer, R John Simes and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
7.0field-weighted citation impact, top 2% 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

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Current perspectives on lipid management in diabetic kidney disease: Can fibrates offer advantages over statins for renal outcomes?Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2026
    Review
  10. Observational
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Increased intracellular miR-142 in adults with Type 1 diabetes.Journal of diabetes and its complications · 2023
    Article
  18. Observational
  19. Review
  20. Review of SGLT2i for the Treatment of Renal Complications: Experience in Patients with and Without T2D.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    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

13 authors at 6 institutions in 2 countries.

Ru-Dee TingNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia. rudee.ting@ctc.usyd.edu.au
Anthony C Keech
Paul L Drury
Mark W Donoghoe
John Hedley
Alicia J Jenkins
Timothy M E Davis
Seppo Lehto
David Celermajer
R John Simes
Kushwin Rajamani
Kim Stanton
FIELD Study Investigators
National Health and Medical Research Council · AUUniversity of Sydney · AUKuopio University Hospital · FIRoyal Perth Hospital · AURoyal Prince Alfred Hospital · AUUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDiabetic patients with moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2)) are at particular cardiovascular risk. Fenofibrate's safety in these patients is an issue because it may elevate plasma creatinine. Furthermore, guidelines regarding fenofibrate dosing in renal impairment vary internationally. We investigated fenofibrate's effects on cardiovascular and end-stage renal disease (ESRD) events, according to eGFR, in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. RESEARCH DESIGN AND

methodsType 2 diabetic patients (aged 50-75 years) with eGFR ≥30 mL/min/1.73 m(2) were randomly allocated to a fixed dose of fenofibrate (200 mg daily) (n = 4,895) or placebo (n = 4,900) for 5 years. Baseline renal function (Modification of Diet in Renal Disease equation) was grouped by eGFR (30-59, 60-89, and ≥90 mL/min/1.73 m(2)). The prespecified outcome was total cardiovascular events (composite of cardiovascular death, myocardial infarction, stroke, and coronary/carotid revascularization). Serious adverse events and instances of ESRD (plasma creatinine >400 μmol/L, dialysis, renal transplant, or renal death) were recorded. Analysis was by intention to treat.

resultsOverall, fenofibrate reduced total cardiovascular events, compared with placebo (hazard ratio 0.89 [95% CI 0.80-0.99]; P = 0.035). This benefit was not statistically different across eGFR groupings (P = 0.2 for interaction) (eGFR 30-59 mL/min/1.73 m(2): 0.68 [0.47-0.97], P = 0.035; eGFR ≥90 mL/min/1.73 m(2): 0.85 [0.70-1.02], P = 0.08). ESRD rates were similar between treatment arms, without adverse safety signals of fenofibrate use in renal impairment.

conclusionsPatients with type 2 diabetes and moderate renal impairment benefit from long-term fenofibrate, without excess drug-related safety concerns compared with those with no or mild renal impairment. Fenofibrate treatment should not be contraindicated in moderate renal impairment, suggesting that current guidelines may be too restrictive.

Indexed as

AgedCardiovascular DiseasesDiabetes Mellitus, Type 2FemaleFenofibrateGlomerular Filtration RateHumansHypolipidemic AgentsKidney Failure, ChronicMaleMiddle AgedFenofibrateHypolipidemic Agents

Identifiers

PMID22210576
PMCPMC3263870
OpenAlexW2044493153

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.