Evidence map›Paper›PMID 11757504›Full record

Trial reportThe New England journal of medicine2001

Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.

B G Brown, X Q Zhao, A Chait, L D Fisher, M C Cheung, J S Morse, A A Dowdy, E K Marino, E L Bolson, P Alaupovic and 2 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00000553. Cited by 404 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
404citing papers in PubMed, 21 pooled it
113.8field-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.

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.

NCT00000553 phase3completed

HDL-Atherosclerosis Treatment Study (HATS)

Ran1994Registered outcomes0Posted comparisons0ConditionsCardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial IschemiaArmsAntioxidants, niacin, simvastatin
PMID 12377728PMID 7572694PMID 9594927PMID 9920522other papers from this trial
Open the trial in the graph
NCT00127218 phase3completedstarted 2003, after this paper: background citation

HDL Increased Plaque Stabilization in the Elderly

Ran2003Enrolled145Registered outcomes2Posted comparisons0ConditionsAtherosclerosis, Cardiovascular DiseaseArmsany statin, niacin, Placebo
PMID 9761083PMID 9989957other papers from this trial
Open the trial in the graph
NCT00397657 phase4terminatedstarted 2006, after this paper: background citation

ARBITER 6: ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6 - HDL and LDL Treatment Strategies in Atherosclerosis (HALTS)

Ran2006Enrolled400Registered outcomes5Posted comparisons0ConditionsAtherosclerosisArmsExtended release niacin, Ezetimibe
PMID 12379573PMID 12505224PMID 8248954PMID 7886711PMID 7743614PMID 2243429PMID 2215615PMID 17076985PMID 15537681PMID 14996776PMID 8616937other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

404 citing papers in PubMed, 21 syntheses or guidelines pooled it, 1,985 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Vitamin C Intake and Ischemic Stroke.Frontiers in nutrition · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Niacin for primary and secondary prevention of cardiovascular events.The Cochrane database of systematic reviews · 2017 · on this map
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Guideline
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Guideline
  18. Pooled it
  19. Pooled it
  20. Pooled it

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 2 countries.

B G BrownDepartment of Medicine, University of Washington School of Medicine, Seattle 98195, USA.
X Q Zhao
A Chait
L D Fisher
M C Cheung
J S Morse
A A Dowdy
E K Marino
E L Bolson
P Alaupovic
J Frohlich
J J Albers
Institute of Nutrition, Metabolism and Diabetes · CAUniversity of Washington · USOklahoma Medical Research Foundation · USUniversity of British Columbia · CA

Funding

Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Sakeneh Zraika · 1986 to 2026
$41.4M
PILOT STUDY--CLINICAL NUTRITION RESEARCHP30DK035816 · NIDDK · UNIVERSITY OF WASHINGTON · PI Ellen A Schur · 1986 to 2026
$30.4M
DOES ATHEROSCLEROSIS REGRESS WITH THERAPY FOR LOW HDLC?R01HL049546 · NHLBI · UNIVERSITY OF WASHINGTON · PI BROWN, BRUCE G · 1994 to 2000
$326k
NHLBI NIH HHS R01 HL49546NIDDK NIH HHS DK 17047NIDDK NIH HHS DK 35816PHS HHS MO1 00037
6 · The paper itself

Abstract

backgroundBoth lipid-modifying therapy and antioxidant vitamins are thought to have benefit in patients with coronary disease. We studied simvastatin-niacin and antioxidant-vitamin therapy, alone and together, for cardiovascular protection in patients with coronary disease and low plasma levels of HDL.

methodsIn a three-year, double-blind trial, 160 patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol levels were randomly assigned to receive one of four regimens: simvastatin plus niacin, vitamins, simvastatin-niacin plus antioxidants; or placebos. The end points were arteriographic evidence of a change in coronary stenosis and the occurrence of a first cardiovascular event (death, myocardial infarction, stroke, or revascularization).

resultsThe mean levels of LDL and HDL cholesterol were unaltered in the antioxidant group and the placebo group; these levels changed substantially (by -42 percent and +26 percent, respectively) in the simvastatin-niacin group. The protective increase in HDL2 with simvastatin plus niacin was attenuated by concurrent therapy with antioxidants. The average stenosis progressed by 3.9 percent with placebos, 1.8 percent with antioxidants (P=0.16 for the comparison with the placebo group), and 0.7 percent with simvastatin-niacin plus antioxidants (P=0.004) and regressed by 0.4 percent with simvastatin-niacin alone (P<0.001). The frequency of the clinical end point was 24 percent with placebos; 3 percent with simvastatin-niacin alone; 21 percent in the antioxidant-therapy group; and 14 percent in the simvastatin-niacin-plus-antioxidants group.

conclusionsSimvastatin plus niacin provides marked clinical and angiographically measurable benefits in patients with coronary disease and low HDL levels. The use of antioxidant vitamins in this setting must be questioned.

Indexed as

alpha-TocopherolAntioxidantsApolipoproteinsAscorbic Acidbeta CaroteneCardiovascular DiseasesCholesterol, HDLCholesterol, LDLCoronary AngiographyCoronary DiseaseCoronary StenosisDouble-Blind MethodDrug InteractionsDrug Therapy, CombinationFemaleHumansalpha-TocopherolAntioxidantsApolipoproteinsAscorbic Acidbeta CaroteneCholesterol, HDLCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsLipidsNiacinSeleniumSimvastatinVitamin E

Identifiers

PMID11757504
OpenAlexW2046991199

What OpenQuestion 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 OpenQuestion graph.