Evidence map›Paper›PMID 22686415›Full record

Trial reportThe New England journal of medicine2012

n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia.

ORIGIN Trial Investigators, Jackie Bosch, Hertzel C Gerstein, Gilles R Dagenais, Rafael Díaz, Leanne Dyal, Hyejung Jung, Aldo P Maggiono, Jeffrey Probstfield, Ambady Ramachandran and 3 more

3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 370 papers, 35 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
370citing papers in PubMed, 35 pooled it
76.0field-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.

NCT00069784 phase3completednot on this map

A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

TypeinterventionalSponsorSanofiRan2003 to 2011Enrolled12,537ConditionsDiabetes Mellitus, Non-Insulin-DependentArmsinsulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), placebo, reusable pen device for insulin injection
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
3 · Its place in the literature

Who cites it

370 citing papers in PubMed, 35 syntheses or guidelines pooled it, 928 citations in OpenAlex.

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  5. Omega-3 fatty acids for intermittent claudication.The Cochrane database of systematic reviews · 2024
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  17. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
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  18. Omega-3 for the prevention of cardiovascular diseases: meta-analysis and trial-sequential analysis.European journal of hospital pharmacy : science and practice · 2022
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310 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

ORIGIN Trial Investigators
Jackie Bosch
Hertzel C Gerstein
Gilles R Dagenais
Rafael Díaz
Leanne Dyal
Hyejung Jung
Aldo P Maggiono
Jeffrey Probstfield
Ambady Ramachandran
Matthew C Riddle
Lars E Rydén
Salim Yusuf

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown.

methodsIn this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here.

resultsDuring a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P=0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P=0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P=0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups.

conclusionsDaily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

Indexed as

AgedCardiovascular DiseasesCholesterolDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFatty Acids, Omega-3FemaleFollow-Up StudiesGlucose IntoleranceHumansHypoglycemic AgentsIncidenceInsulin GlargineInsulin, Long-ActingIntention to Treat AnalysisCholesterolFatty Acids, Omega-3Hypoglycemic AgentsInsulin GlargineInsulin, Long-ActingTriglycerides

Identifiers

PMID22686415
OpenAlexW1560062315

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.