Evidence map›Paper›PMID 29903515›Full record

Trial reportInternational journal of cardiology2018

The nonalcoholic fatty liver disease (NAFLD) fibrosis score, cardiovascular risk stratification and a strategy for secondary prevention with ezetimibe.

Tracey G Simon, Kathleen E Corey, Christopher P Cannon, Michael Blazing, Jeong-Gun Park, Michelle L O'Donoghue, Raymond T Chung, Robert P Giugliano

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of cardiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00202878. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT00202878 phase3completed

A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)

Ran2005Enrolled18,144Registered outcomes4Posted comparisons4ConditionsHypercholesterolemia, Myocardial InfarctionArmsezetimibe/simvastatin, Placebo for ezetimibe 10 mg/simvastatin 40 mg combination, Placebo for simvastatin 40 mg, simvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Tracey G SimonLiver Center, Gastrointestinal Division, Department of Medicine, Massachusetts General Hospital, United States; Harvard Medical School, Boston, MA, United States.
Kathleen E CoreyLiver Center, Gastrointestinal Division, Department of Medicine, Massachusetts General Hospital, United States; Harvard Medical School, Boston, MA, United States.
Christopher P CannonHarvard Medical School, Boston, MA, United States; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, United States.
Michael BlazingDuke Clinical Research Institute, Durham, NC, United States.
Jeong-Gun ParkTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, United States.
Michelle L O'DonoghueHarvard Medical School, Boston, MA, United States; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, United States.
Raymond T ChungLiver Center, Gastrointestinal Division, Department of Medicine, Massachusetts General Hospital, United States; Harvard Medical School, Boston, MA, United States.
Robert P GiuglianoHarvard Medical School, Boston, MA, United States; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, United States. Electronic address: rgiugliano@partners.org.
Brigham and Women's Hospital · USHarvard University · USClinical Research Institute · US

Funding

Patient-Oriented Research on Hepatitis in Special PopulationsK24DK078772 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHUNG, RAYMOND T · 2007 to 2016
$1.6M
The Impact of Obstructive Sleep Apnea on Non-Alcoholic Fatty Liver DiseaseK23DK099422 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI COREY, KATHLEEN ELIZABETH · 2013 to 2017
$938k
NIDDK NIH HHS K23 DK099422NIDDK NIH HHS K24 DK078772
6 · The paper itself

Abstract

objectiveThe nonalcoholic fatty liver disease fibrosis score (NFS) is comprised of unique metabolic risk indicators that may accurately predict residual cardiovascular (CV) risk in patients with established coronary disease and metabolic dysfunction.

methodsWe applied the NFS prospectively to 14,819 post-ACS patients randomized to ezetimibe/simvastatin (E/S) or placebo/simvastatin (P/S), in the IMPROVE-IT trial, using validated NFS cutoffs. The primary endpoint included CV death, myocardial infarction, unstable angina, revascularization or stroke. Outcomes were compared between NFS categories and treatment arms using frequency of events, KM rates and adjusted Cox proportional hazard models. The ability of the NFS to predict recurrent CV events was independently validated in 5395 placebo-treated patients enrolled in the SOLID-TIMI 52 trial.

resultsAmong 14,819 patients enrolled in IMPROVE-IT, 14.2% (N = 2106) were high-risk (NFS > 0.67). The high-risk group had a 30% increased risk of recurrent major CV events, compared to the low-risk NFS group (HR 1.30 [1.19-1.43]; p < 0.001). Among high-risk patients, ezetimibe/simvastatin conferred a 3.7% absolute reduction in risk of recurrent CV events, compared to placebo/simvastatin (HR 0.85 [0.74-0.98]), translating to a number-needed-to-treat of 27. Similar benefit was not found in the low-risk group (HR ezetimibe/simvastatin vs. placebo/simvastatin, 1.01 [0.91-1.12]; p-interaction = 0.053). The relationship between NFS category and recurrent CV events was independently validated in patients enrolled in SOLID-TIMI 52 (HR for NFS > 0.67 vs. NFS < -1.455 = 1.55 [1.32-1.81]; p < 0.001).

conclusionStratification of cardiovascular risk by NFS identifies an independent population of patients who are at highest risk of recurrent events, and most likely to benefit from dual lipid-lowering therapy. Clinical trials.gov: NCT00202878.

Indexed as

AgedAnticholesteremic AgentsCardiovascular DiseasesEzetimibeFemaleHumansInternationalityLiver CirrhosisMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseProspective StudiesRisk FactorsSecondary PreventionSeverity of Illness IndexAnticholesteremic AgentsEzetimibeAcute coronary syndromeCardiovascular diseaseEzetimibeFatty liverLow-density lipoprotein cholesterolMetabolic syndromeNAFLDStatin

Identifiers

PMID29903515
PMCPMC6139264
OpenAlexW2804174152

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.