Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis

Simple item page
dc.contributor.authorFellstrom, B.
dc.contributor.authorJardine, A.
dc.contributor.authorSchmeider, R.
dc.contributor.authorHoldaas, H.
dc.contributor.authorBannister, K.
dc.contributor.authorBeutler, J.
dc.contributor.authorChae, D.
dc.contributor.authorChevaile, A.
dc.contributor.authorCobbe, S.
dc.contributor.authorGronhagen-Riska, C.
dc.contributor.authorDe Lima, J.
dc.contributor.authorLins, R.
dc.contributor.authorMayer, G.
dc.contributor.authorMcMahon, A.
dc.contributor.authorParving, H.
dc.contributor.authorSamuelsson, O.
dc.contributor.authorSonkodi, S.
dc.contributor.authorSuleymanlar, G.
dc.contributor.authorTsakiris, D.
dc.contributor.authorTesar, V.
dc.contributor.authoret al.
dc.date.issued2009
dc.description.abstract<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusions</h4>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.)
dc.description.statementofresponsibilityBengt C. Fellström... Kym Bannister... et al.
dc.identifier.citationNew England Journal of Medicine, 2009; 360(14):1395-1407
dc.identifier.doi10.1056/NEJMoa0810177
dc.identifier.issn0028-4793
dc.identifier.issn1533-4406
dc.identifier.urihttp://hdl.handle.net/2440/60455
dc.language.isoen
dc.publisherMassachusetts Medical Soc
dc.rightsCopyright © 2009 Massachusetts Medical Society.
dc.source.urihttps://doi.org/10.1056/nejmoa0810177
dc.subjectAURORA Study Group
dc.subjectHumans
dc.subjectKidney Failure, Chronic
dc.subjectCardiovascular Diseases
dc.subjectSulfonamides
dc.subjectFluorobenzenes
dc.subjectPyrimidines
dc.subjectCholesterol
dc.subjectC-Reactive Protein
dc.subjectHydroxymethylglutaryl-CoA Reductase Inhibitors
dc.subjectTreatment Failure
dc.subjectRenal Dialysis
dc.subjectFollow-Up Studies
dc.subjectProspective Studies
dc.subjectDouble-Blind Method
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectRosuvastatin Calcium
dc.titleRosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis
dc.typeJournal article
pubs.publication-statusPublished

Files

Collections

Medicine publications