Evidence map›Paper›PMID 16034009›Full record

Trial reportThe New England journal of medicine2005

Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis.

Christoph Wanner, Vera Krane, Winfried März, Manfred Olschewski, Johannes F E Mann, Günther Ruf, Eberhard Ritz, German Diabetes and Dialysis Study Investigators

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 809 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
809citing papers in PubMed, 19 pooled it
120.0field-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.

NCT03480568 phase3recruitingstarted 2018, after this paper: background citation

A Phase III Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen: The Alidial Study

Ran2018Enrolled20Registered outcomes5Posted comparisons0ConditionsAtherosclerotic Disease, Hemodialysis, Hypercholesterolemia, Peritoneal DialysisArmsAlirocumab 150 MG/ML [Praluent]
PMID 21493741PMID 26924051PMID 26444323PMID 19332456PMID 24072417PMID 21663949PMID 22461539PMID 25019001PMID 21307840PMID 20082919PMID 17167114other papers from this trial
Open the trial in the graph
NCT03696940 phase3unknown statusstarted 2018, after this paper: background citation

Estudio clínico Fase III Para Evaluar la Eficacia terapéutica en Pacientes Mexicanos Con Dislipidemia Mediante el Uso vía Oral de L-Carnitina + Atorvastatina Comparado Con Atorvastatina

Ran2018Enrolled120Registered outcomes6Posted comparisons0ConditionsCardiovascular Risk Factor, DyslipidemiasArmsAtorvastatin 10mg, L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg
PMID 27046161PMID 25537708PMID 24793440PMID 24793441PMID 24793443PMID 26939026PMID 17039901PMID 23190071PMID 19604523PMID 25915661PMID 19618992PMID 16384561other papers from this trial
Open the trial in the graph
NCT04659525 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

Phase IV Study for Efficacy and Safety of Evolocumab Added to Ezetimibe (Standard of Care) in High Cardiovascular Risk Haemodialized Statin Intolerant Patients With Hypercholesterolemia

TypeinterventionalSponsorPoliclinico Casilino ASL RMBRan2020 to 2021Enrolled50ConditionsHypercholesterolemia, CKD Stage 5, Chronic Kidney Disease Requiring Chronic DialysisArmsEvolocumab, Ezetimibe, Placebo
3 · Its place in the literature

Who cites it

809 citing papers in PubMed, 19 syntheses or guidelines pooled it, 2,583 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  7. Statins for the primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2024
    Pooled it
  8. 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
  9. Pooled it
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  11. The association of statin therapy and cancer: a meta-analysis.Lipids in health and disease · 2023 · on this map
    Pooled it
  12. Pooled it
  13. Pooled it
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  15. Pooled it
  16. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  17. Pooled it
  18. Pooled it
  19. Statins in Healthy Adults: A Meta-Analysis.Medicina (Kaunas, Lithuania) · 2021
    Pooled it
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Christoph WannerDivision of Nephrology, Department of Medicine, University of Würzburg, Würzburg, Germany. wanner_c@medizin.uni-wuerzburg.de
Vera Krane
Winfried März
Manfred Olschewski
Johannes F E Mann
Günther Ruf
Eberhard Ritz
German Diabetes and Dialysis Study Investigators
University of Würzburg · DEHeidelberg University · DEMünchen Klinik Schwabing · DEPfizer (Germany) · DEUniversity Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStatins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined.

methodsWe conducted a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis who were randomly assigned to receive 20 mg of atorvastatin per day or matching placebo. The primary end point was a composite of death from cardiac causes, nonfatal myocardial infarction, and stroke. Secondary end points included death from all causes and all cardiac and cerebrovascular events combined.

resultsAfter four weeks of treatment, the median level of low-density lipoprotein cholesterol was reduced by 42 percent among patients receiving atorvastatin, and among those receiving placebo it was reduced by 1.3 percent. During a median follow-up period of four years, 469 patients (37 percent) reached the primary end point, of whom 226 were assigned to atorvastatin and 243 to placebo (relative risk, 0.92; 95 percent confidence interval, 0.77 to 1.10; P=0.37). Atorvastatin had no significant effect on the individual components of the primary end point, except that the relative risk of fatal stroke among those receiving the drug was 2.03 (95 percent confidence interval, 1.05 to 3.93; P=0.04). Atorvastatin reduced the rate of all cardiac events combined (relative risk, 0.82; 95 percent confidence interval, 0.68 to 0.99; P=0.03, nominally significant) but not all cerebrovascular events combined (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49) or total mortality (relative risk, 0.93; 95 percent confidence interval, 0.79 to 1.08; P=0.33).

conclusionsAtorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.

Indexed as

Renal DialysisAgedAtorvastatinCerebrovascular DisordersCholesterol, LDLDiabetes Mellitus, Type 2Double-Blind MethodFemaleHeart DiseasesHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIncidenceMaleMiddle AgedMyocardial InfarctionAtorvastatinCholesterol, LDLHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPyrroles

Identifiers

PMID16034009
OpenAlexW2110601215

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.