Trial reportLancet (London, England)2003

Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial.

Hallvard Holdaas, Bengt Fellström, Alan G Jardine, Ingar Holme, Gudrun Nyberg, Per Fauchald, Carola Grönhagen-Riska, Søren Madsen, Hans-Hellmut Neumayer, Edward Cole and 7 more

Registry-linked trialAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2003. The graph read 1 number from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. It is linked to trial NCT02058875 (Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring.), which is not on this map. Cited by 203 papers, 42 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
203citing papers in PubMed, 42 pooled it
59.2field-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.

← favours the treatmentfavours the comparator →
1 · no effect
Cardiovascular eventsno clear difference · against placebo · ascvd, dyslipidemiafeeds one cell of the map
RR 0.830.64 to 1.06p=0.139
Risk reduction with fluvastatin for the primary endpoint (risk ratio 0.83 [95% CI 0.64-1.06], p=0.139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0.65 [0.48-0.88] p=0.005) in the fluvastatin group than in the placebo group.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×cardiovascular events

InconclusiveOpen on the map →What to test next →

30 readable studies in this cell: 18 favour the treatment, 11 find no difference, 1 favour the comparator.

Belief with this paper
0.86replicated · 12 families support, 2 contradict · against placebo
Without it
0.86This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2003
RR 0.830.64 to 1.06
HR 0.760.64 to 0.91
NCT023442907,769 enrolled · 2015
HR 0.640.48 to 0.84
HR 1.781.00 to 3.17
NCT03944512102 enrolled · 2019
RR 0.670.37 to 1.19
4 · 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.

NCT02058875 phase4withdrawnnot on this mapstarted 2014, after this paper: background citation

Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring.

TypeinterventionalSponsorUniversity of SaskatchewanRan2014 to 2015Enrolled0ConditionsCardiovascular Disease, Cardiovascular Outcomes, Kidney Transplant Recipients, Kidney TransplantationArmsMyfortic®, Neoral®, Cellcept®, Prednisone
5 · Its place in the literature

Who cites it

203 citing papers in PubMed, 42 syntheses or guidelines pooled it, 922 citations in OpenAlex.

  1. Pooled it
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  3. Statins for the primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2024
    Pooled it
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  6. Guideline
  7. Benefits and Risks of Antihyperlipidemic Medication in Adults with Different Low-Density Lipoprotein Cholesterol Based on the Number Needed to Treat.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024 · on this map
    Pooled it
  8. Pooled it
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  10. The association of statin therapy and cancer: a meta-analysis.Lipids in health and disease · 2023 · on this map
    Pooled it
  11. Pooled it
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  15. Prevalence of statin intolerance: a meta-analysis.European heart journal · 2022 · on this map
    Pooled it
  16. Pooled it
  17. Statins in Healthy Adults: A Meta-Analysis.Medicina (Kaunas, Lithuania) · 2021
    Pooled it
  18. Pooled it
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  20. Pooled it

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

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

17 authors at 12 institutions in 8 countries.

Hallvard Holdaashallvard.holdaas@rikshospitalet.no
Bengt Fellström
Alan G Jardine
Ingar Holme
Gudrun Nyberg
Per Fauchald
Carola Grönhagen-Riska
Søren Madsen
Hans-Hellmut Neumayer
Edward Cole
Bart Maes
Patrice Ambühl
Anders G Olsson
Anders Hartmann
Dag O Solbu
Terje R Pedersen
Assessment of LEscol in Renal Transplantation (ALERT) Study Investigators
Oslo University Hospital · NOAarhus University Hospital · DKCharité - Universitätsmedizin Berlin · DEHelsinki University Hospital · FILinköping University Hospital · SENovartis (Norway) · NORigshospitalet · DKSahlgrenska University Hospital · SEToronto General Hospital · CAUniversity Hospital of Zurich · CHUniversity of Glasgow · GBUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundRenal transplant recipients are at increased risk of premature cardiovascular disease. Although statins reduce cardiovascular risk in the general population, their efficacy and safety in renal transplant recipients have not been established. We investigated the effects of fluvastatin on cardiac and renal endpoints in this population.

methodsWe did a multicentre, randomised, double-blind, placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4.0-9.0 mmol/L. We randomly assigned patients fluvastatin (n=1050) or placebo (n=1052) and follow up was for 5-6 years. The primary endpoint was the occurrence of a major adverse cardiac event, defined as cardiac death, non-fatal myocardial infarction (MI), or coronary intervention procedure. Secondary endpoints were individual cardiac events, combined cardiac death or non-fatal MI, cerebrovascular events, non-cardiovascular death, all-cause mortality, and graft loss or doubling of serum creatinine. Analysis was by intention to treat.

findingsAfter a mean follow-up of 5.1 years, fluvastatin lowered LDL cholesterol concentrations by 32%. Risk reduction with fluvastatin for the primary endpoint (risk ratio 0.83 [95% CI 0.64-1.06], p=0.139) was not significant, although there were fewer cardiac deaths or non-fatal MI (70 vs 104, 0.65 [0.48-0.88] p=0.005) in the fluvastatin group than in the placebo group. Coronary intervention procedures and other secondary endpoints did not differ significantly between groups.

interpretationAlthough cardiac deaths and non-fatal MI seemed to be reduced, fluvastatin did not generally reduce rates of coronary intervention procedures or mortality. Overall effects of fluvastatin were similar to those of statins in other populations.

Indexed as

Kidney TransplantationAdultAgedAnticholesteremic AgentsCardiovascular DiseasesCholesterol, LDLDouble-Blind MethodDrug InteractionsFatty Acids, MonounsaturatedFemaleFluvastatinFollow-Up StudiesHumansImmunosuppressive AgentsIndolesMaleAnticholesteremic AgentsCholesterol, LDLFatty Acids, MonounsaturatedFluvastatinImmunosuppressive AgentsIndolesPlacebos

Identifiers

PMID12814712
OpenAlexW2156880046

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.