Evidence map›Paper›PMID 31707829›Full record

Trial reportCirculation2020

REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States.

Deepak L Bhatt, Michael Miller, Eliot A Brinton, Terry A Jacobson, Ph Gabriel Steg, Steven B Ketchum, Ralph T Doyle, Rebecca A Juliano, Lixia Jiao, Craig Granowitz and 8 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01492361. Cited by 61 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01492361 phase3completed

Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)

Ran2011Enrolled8,179Registered outcomes10Posted comparisons10ConditionsCardiovascular DiseasesArmsAMR101, Placebo, Statin therapy
PMID 30415628PMID 35027114PMID 30898607PMID 31439224PMID 33010162PMID 33148016PMID 34620410PMID 34710343PMID 34706555PMID 28294373other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Deepak L BhattBrigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).
Michael MillerDepartment of Medicine, University of Maryland School of Medicine, Baltimore (M.M.).
Eliot A BrintonUtah Lipid Center, Salt Lake City (E.A.B.).
Terry A JacobsonLipid Clinic and Cardiovascular Risk Reduction Program, Department of Medicine, Emory University School of Medicine, Atlanta, GA (T.A.J.).
Ph Gabriel StegFrench Alliance for Cardiovascular Trials, Hôpital Bichat, Paris, France (P.G.S.).
Steven B KetchumAmarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).
Ralph T DoyleAmarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).
Rebecca A JulianoAmarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).
Lixia JiaoAmarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).
Craig GranowitzAmarin Pharma, Inc., Bridgewater, NJ (S.B.K., R.T.D., R.A.J., L.J., C.G.).
Jean-Claude TardifMontreal Heart Institute, Université de Montréal, Quebec, Canada (J.-C.T.).
Brian OlshanskyUniversity of Iowa, Iowa City (B.O.).
Mina K ChungCleveland Clinic, OH (M.K.C.).
C Michael GibsonBeth Israel Deaconess Hospital, Boston, MA (C.M.G.).
Robert P GiuglianoCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.P.G.).
Matthew J BudoffLos Angeles Biomedical Research Institute at Harbor UCLA Medical Center, Torrance, CA (M.J.B.).
Christie M BallantyneDepartment of Medicine, Baylor College of Medicine, Houston, TX (C.M.B.).
REDUCE-IT Investigators

Funding

NHLBI NIH HHS R01 HL111314
6 · The paper itself

Abstract

backgroundSome trials have found that patients from the United States derive less benefit than patients enrolled outside the United States. This prespecified REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial) subgroup analysis was conducted to determine the degree of benefit of icosapent ethyl in the United States.

methodsREDUCE-IT randomized 8179 statin-treated patients with qualifying triglycerides ≥135 and <500 mg/dL and low-density lipoprotein cholesterol >40 and ≤100 mg/dL and a history of atherosclerosis or diabetes mellitus to icosapent ethyl 4 g/d or placebo. The primary composite end point was cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary composite end point was cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. A hierarchy was prespecified for examination of individual and composite end points.

resultsA total of 3146 US patients (38.5% of the trial) were randomized and followed for a median of 4.9 years; 32.3% were women and 9.7% were Hispanic. The primary composite end point occurred in 24.7% of placebo-treated patients versus 18.2% of icosapent ethyl-treated patients (hazard ratio [HR], 0.69 [95% CI, 0.59-0.80];

conclusionsWhereas the non-US subgroup showed significant reductions in the primary and key secondary end points, the US subgroup demonstrated particularly robust risk reductions across a variety of individual and composite end points, including all-cause mortality. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01492361.

Indexed as

AgedCholesterol, LDLDouble-Blind MethodEicosapentaenoic AcidFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMyocardial InfarctionRisk FactorsStrokeUnited StatesCholesterol, LDLEicosapentaenoic Acideicosapentaenoic acid ethyl esterHydroxymethylglutaryl-CoA Reductase Inhibitorseicosapentaenoic acid ethyl esterfatty acids, omega-3lipidsprevention and controltriglyceridesUnited States

Identifiers

PMID31707829
PMCPMC7004453

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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.