Trial reportThe New England journal of medicine2010

Effects of combination lipid therapy in type 2 diabetes mellitus.

ACCORD Study Group, Henry N Ginsberg, Marshall B Elam, Laura C Lovato, John R Crouse, Lawrence A Leiter, Peter Linz, William T Friedewald, John B Buse, Hertzel C Gerstein and 8 more

Erratum issued 4 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph read 1 number from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. An erratum has been issued. It reports registered trial NCT00000620. Cited by 943 papers, 9 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
943citing papers in PubMed, 9 pooled it
147.8field-weighted citation impact, top 1% 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.

← favours the treatmentfavours the comparator →
1 · no effect
All-cause mortalityno clear difference · against placebo · ascvd, dyslipidemiafeeds one cell of the map
HR 0.910.75 to 1.10P=0.33
Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (hazard ratio, 0.91; 95% CI, 0.75 to 1.10; P=0.33).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Other lipid agents×all-cause mortality

InconclusiveOpen on the map →What to test next →

2 readable studies in this cell: 2 favour the treatment, 0 find no difference, 0 favour the comparator.

Belief with this paper
0.50one trial · 1 family supports, 0 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
NCT0020287818,144 enrolled · 2005
HR 0.940.89 to 0.99

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

NCT00000620 phase3completed

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

Ran1999Enrolled10,251Registered outcomes6Posted comparisons6ConditionsAtherosclerosis, Cardiovascular Diseases, Coronary Disease, Diabetes MellitusArmsAnti-hyperglycemic Agents, Anti-hypertensive Agents, Blinded fenofibrate or placebo plus simvastatin
Open the trial in the graph
NCT01945268 phase4completednot on this mapstarted 2015, after this paper: background citation

A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study

TypeinterventionalSponsorMcMaster UniversityRan2015 to 2015Enrolled107ConditionsHeart FailureArmsinactivated trivalent influenza vaccine, Sterile saline
NCT02762851 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events

TypeinterventionalSponsorMcMaster UniversityRan2016 to 2020Enrolled5,000ConditionsHeart Failure, InfluenzaArmsSterile saline, inactivated trivalent influenza vaccine
NCT04517396 phase2completednot on this mapstarted 2020, after this paper: background citation

FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019

TypeinterventionalSponsorUniversity of PennsylvaniaRan2020 to 2022Enrolled701ConditionsCovid19ArmsFenofibrate/fenofibric acid, Placebo, Usual care
5 · Its place in the literature

Who cites it

943 citing papers in PubMed, 9 syntheses or guidelines pooled it, 2,825 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Fenofibrate for diabetic retinopathy.The Cochrane database of systematic reviews · 2023
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Review

883 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

18 authors.

ACCORD Study Group
Henry N Ginsberg
Marshall B Elam
Laura C Lovato
John R Crouse
Lawrence A Leiter
Peter Linz
William T Friedewald
John B Buse
Hertzel C Gerstein
Jeffrey Probstfield
Richard H Grimm
Faramarz Ismail-Beigi
J Thomas Bigger
David C Goff
William C Cushman
Denise G Simons-Morton
Robert P Byington

Funding

Assembly &Secretion Of Apo B Containing LipoproteinsR01HL055638 · COLUMBIA UNIVERSITY HEALTH SCIENCES · 1996 to 2005
$2.2M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095183 · MINNEAPOLIS MEDICAL RESEARCH FDN, INC. · 1999 to 2000
$1.9M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095181 · CASE WESTERN RESERVE UNIVERSITY · 1999 to 2000
$1.8M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095184 · COLUMBIA UNIVERSITY HEALTH SCIENCES · 1999 to 2000
$1.7M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095182 · WAKE FOREST UNIVERSITY · 1999 to 2000
$1.6M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUS-N01HC95178N01HC095178 · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 1999 to 2005
$1.5M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETER MELLLITN01HC095180 · UNIVERSITY OF WASHINGTON · 1999 to 2000
$1.5M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095179 · MCMASTER UNIVERSITY · 1999 to 2000
$1.3M
Fatty Acid Regulation of Liver Lipoprotein ProductionR01HL073030 · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2003 to 2005
$1.2M
NCRR NIH HHS UL1 RR024156NHLBI NIH HHS IAAY1-HC-1010NHLBI NIH HHS IAAY1-HC-9035NHLBI NIH HHS N01 HC095178NHLBI NIH HHS N01 HC095179NHLBI NIH HHS N01 HC095180NHLBI NIH HHS N01 HC095181NHLBI NIH HHS N01 HC095182NHLBI NIH HHS N01 HC095183NHLBI NIH HHS N01 HC095184NHLBI NIH HHS N01-HC-95178NHLBI NIH HHS N01-HC-95179NHLBI NIH HHS N01-HC-95180NHLBI NIH HHS N01-HC-95181NHLBI NIH HHS N01-HC-95182NHLBI NIH HHS N01-HC-95183NHLBI NIH HHS N01-HC-95184NHLBI NIH HHS R01 HL055638NHLBI NIH HHS R01 HL073030NHLBI NIH HHS Y01 HC001010NHLBI NIH HHS Y01 HC009035
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundWe investigated whether combination therapy with a statin plus a fibrate, as compared with statin monotherapy, would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease.

methodsWe randomly assigned 5518 patients with type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo. The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.

resultsThe annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32). There were also no significant differences between the two study groups with respect to any secondary outcome. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (hazard ratio, 0.91; 95% CI, 0.75 to 1.10; P=0.33). Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex, with a benefit for men and possible harm for women (P=0.01 for interaction), and a possible interaction according to lipid subgroup, with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol (P=0.057 for interaction).

conclusionsThe combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke, as compared with simvastatin alone. These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)

Indexed as

AgedCardiovascular DiseasesCholesterolDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleFenofibrateFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionProportional Hazards ModelsCholesterolFenofibrateHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsSimvastatinTriglycerides

Identifiers

PMID20228404
PMCPMC2879499
OpenAlexW2164324917

What Socratic holds

Texttitle and abstract
LicenceTDM
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.