Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis
Open accessAbstract
BACKGROUND: Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. METHODS: We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events. RESULTS: After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.51). CONCLUSIONS: In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.)
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In patients with kidney failure treated with dialysis, primary prevention of ASCVD events with a statin has been generally ineffective.
“An exception may be patients with kidney failure treated with dialysis for whom primary prevention of ASCVD events with a statin has been generally ineffective (47,49,50).”
From Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) (2022) · cites this paper as [49]
The Primary Outcomes section reports no significant reduction in cardiovascular events with rosuvastatin, and Secondary Outcomes and Subgroups says the lack of effect was consistent among patients without preexisting cardiovascular disease. This supports the primary-prevention point for the trial’s hemodialysis patients, but the paper does not establish that statins are generally ineffective for all patients receiving dialysis. (LLM, conf=0.85)
Experimental — accuracy not yet measuredCVD remains the leading cause of mortality among patients with CKD.
“CKD is strongly associated with dyslipidemia, and CVD remains the leading cause of mortality among patients with CKD.25,26,28”
From Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL (2021) · cites this paper as [28]
The Patients section (page not available) reports 648 cardiovascular deaths among 1,164 adjudicated deaths in the trial, supporting cardiovascular disease as a major cause of death in patients undergoing hemodialysis. The study concerns patients with end-stage renal disease on hemodialysis; it does not establish that CVD is the leading cause of mortality among all patients with CKD. (LLM, conf=0.88)
Experimental — accuracy not yet measuredCKD is strongly associated with dyslipidemia.
“CKD is strongly associated with dyslipidemia, and CVD remains the leading cause of mortality among patients with CKD.25,26,28”
From Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL (2021) · cites this paper as [28]
The introduction discusses lipid-lowering therapy in hemodialysis patients and says LDL cholesterol may be low or normal in advanced renal disease; it does not state that CKD is strongly associated with dyslipidemia. The References list a work on dyslipidemia in chronic renal failure, but its title does not establish the claimed association in this paper. No page number is available in our copy. (LLM, conf=0.72)
Experimental — accuracy not yet measuredStatin trials 4D and AURORA failed to demonstrate efficacy in reducing CV events in patients with CKD.
“Statin trials such as 4D [88] and AURORA [89] failed to demonstrate the efficacy to reduce CV events in patients with CKD.”
From Pemafibrate, a new selective PPARα modulator: drug concept and its clinical applications for dyslipidemia and metabolic diseases (2020) · cites this paper as [89]
In AURORA, rosuvastatin lowered LDL-C as expected but had no significant effect on the composite CVD endpoint in 2776 haemodialysis patients.
“The results from AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events) involving 2776 patients on haemodialysis 40 show that rosuvastatin lowered LDL-C as expected but had no significant effect on the composite CVD endpoint.”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [40]
Statin therapy has a beneficial effect on cardiovascular disease outcomes in chronic kidney disease stages 2 and 3 and slows the rate of kidney function loss.
“Statin therapy has a beneficial effect on CVD outcomes in CKD stages 2 and 3 and slows the rate of kidney function loss.493”
From European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) (2012) · cites this paper as [493]
In AURORA, involving 2776 patients on haemodialysis, rosuvastatin lowered LDL-C as expected but had no significant effect on the composite CVD endpoint.
“The results from AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events), involving 2776 patients on haemodialysis, show that rosuvastatin lowered LDL-C as expected but had no significant effect on the composite CVD endpoint. 396”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [396]
In AURORA, involving 2776 patients on haemodialysis, rosuvastatin lowered LDL-C as expected but had no significant effect on the composite cardiovascular disease endpoint.
“The results from AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events), involving 2776 patients on haemodialysis, show that rosuvastatin lowered LDL-C as expected but had no significant effect on the composite CVD endpoint.396”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [396]
Randomized controlled trials show that statin use did not significantly decrease ASCVD risk in dialysis patients, suggesting the importance of implementing effective measures in patients with earlier stages of CKD.
“This finding is consistent with the results of randomized controlled trials revealing that the use of statin did not decrease the risk for ASCVD significantly in dialysis patients158, 159), suggesting the importance of implementing effective measures on patients with earlier stages of CKD.”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [158]
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“An exception may be patients with kidney failure treated with dialysis for whom primary prevention of ASCVD events with a statin has been generally ineffective.(47,49,50) High-intensity statin is recommended for secondary prevention for all patients with known ASCVD.”
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- Authors
- Fellström, B. C., Jardine, A. G., Schmieder, R. E., Holdaas, H., Bannister, K., Beutler, J., Chae, D.-W., Chevaile, A., Cobbe, S. M., Grönhagen-Riska, C., De Lima, J. J., Lins, R., Mayer, G., McMahon, A. W., Parving, H.-H., Remuzzi, G., Samuelsson, O., Sonkodi, S., Süleymanlar, G., Tsakiris, D., Tesar, V., Todorov, V., Wiecek, A., Wüthrich, R. P., Gottlow, M., Johnsson, E., & Zannad, F.
- Affiliations
- Uppsala University (SE)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-04-02
- Volume
- 360
- Issue
- 14
- Pages
- 1395-1407
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2162430779
- Cited by
- 2,036
- References
- 35
- Citations by year
- 2026: 70 · 2025: 60 · 2024: 72 · 2023: 78 · 2022: 91 · 2021: 95 · 2020: 96 · 2019: 105 · 2018: 92 · 2017: 104 · 2016: 109 · 2015: 113 · 2014: 143 · 2013: 147 · 2012: 174
- FWCI
- 221.03
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- Scientific Electronic Library Online (São Paulo Research Foundation, Latin American and Caribbean Center on Health Sciences Information, Conselho Nacional de Desenvolvimento Científico e Tecnológico) (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- ORBi (University of Liège) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Research Portal (Queen's University Belfast) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Keywords
- rosuvastatin, statins, hemodialysis, end-stage renal disease, cardiovascular events, myocardial infarction, stroke, cardiovascular mortality, LDL cholesterol lowering, all-cause mortality, secondary prevention
- MeSH terms
- Rosuvastatin Calcium, Aged, Aged, 80 and over, C-Reactive Protein, Cardiovascular Diseases, Cholesterol, Double-Blind Method, Female, Fluorobenzenes, Follow-Up Studies, Renal Dialysis, Humans, Kidney Failure, Chronic, Male, Middle Aged, Prospective Studies, Pyrimidines, Sulfonamides, Treatment Failure, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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