Evidence mapPaperPMID 17599426Full record

Trial reportThe American journal of cardiology2007

Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

Henry N Ginsberg, Denise E Bonds, Laura C Lovato, John R Crouse, Marshall B Elam, Peter E Linz, Patrick J O'connor, Lawrence A Leiter, Daniel Weiss, Edward Lipkin and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of cardiology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00000620. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
16.3field-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.

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.

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
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Pooled it
  2. Glucose targets for preventing diabetic kidney disease and its progression.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Genetic Variants inDiabetes · 2018
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Effects of medical therapies on retinopathy progression in type 2 diabetes.The New England journal of medicine · 2010 · on this map
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Effects of intensive glucose lowering in type 2 diabetes.The New England journal of medicine · 2008 · on this map
    Trial
  17. Article
  18. Review
  19. Article
  20. Observational
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

12 authors at 10 institutions in 2 countries.

Henry N GinsbergDepartment of Medicine, Columbia University College of Physicians and Surgeons, New York, New York, USA.
Denise E Bonds
Laura C Lovato
John R Crouse
Marshall B Elam
Peter E Linz
Patrick J O'connor
Lawrence A Leiter
Daniel Weiss
Edward Lipkin
Jerome L Fleg
ACCORD Study Group
Wake Forest University · USColumbia University · USDiabetes & Endocrine Associates · USHealthPartners · USNational Heart Lung and Blood Institute · USNaval Medical Center San Diego · USUniversity of Tennessee Health Science Center · USUniversity of Toronto · CAUniversity of Virginia · USUniversity of Washington · US

Funding

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
NHLBI 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 Y1-HC-1010NHLBI NIH HHS Y1-HC-9035
6 · The paper itself

Abstract

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial aims to test whether a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) plus a fibrate is more efficacious in reducing cardiovascular events than a statin plus placebo in patients with type 2 diabetes mellitus with defined glycemic control. This is a blinded component in a 5,518-patient subset of the ACCORD cohort. These participants were randomized to either be (1) treated with simvastatin (titrated to 40 mg/day if necessary to achieve a goal low-density lipoprotein [LDL] cholesterol level of <2.59 mmol/L [100 mg/dL]) plus placebo or (2) treated to the same goal LDL cholesterol level with the statin plus active fenofibrate 160 mg/day or its bioequivalent (or 54 mg/day if the estimated glomerular filtration rate ranges from 30 to <50 mL/min per 1.73 m2). Setting an upper limit of LDL cholesterol qualifying for randomization excluded patients who would not likely achieve the LDL cholesterol goal. Recruitment for ACCORD began in January 2001, and follow-up is scheduled to end in June 2009. Since recruitment began, several clinical trials and consensus statements have been published that led to changes in the details of the lipid treatment algorithm and protocol. This report describes the design of the lipid protocol and modifications to the protocol during the course of the study in response to and in anticipation of these developments. The current protocol is designed to provide an ethically justifiable test of combined statin plus fibrate treatment consistent with the highest level of safety and lipid treatment standards of care.

Indexed as

Diabetes Mellitus, Type 2Coronary Artery DiseaseDiabetic AngiopathiesDrug Administration ScheduleFenofibrateHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHyperlipidemiasHypolipidemic AgentsRandomized Controlled Trials as TopicResearch DesignFenofibrateHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic Agents

Identifiers

PMID17599426
OpenAlexW2075147537

What Socratic holds

Texttitle and abstract
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.