title: Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.
abstract: 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.)
authors.affiliation: Department of Medical Science, Renal Unit, University Hospital, SE-751 85, Uppsala, Sweden. bengt.fellstrom@medsci.uu.se
authors.forename: Bengt C
authors.initials: BC
authors.lastname: Fellström
authors.forename: Alan G
authors.initials: AG
authors.lastname: Jardine
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
authors.forename: Hallvard
authors.initials: H
authors.lastname: Holdaas
authors.forename: Kym
authors.initials: K
authors.lastname: Bannister
authors.forename: Jaap
authors.initials: J
authors.lastname: Beutler
authors.forename: Dong-Wan
authors.initials: DW
authors.lastname: Chae
authors.forename: Alejandro
authors.initials: A
authors.lastname: Chevaile
authors.forename: Stuart M
authors.initials: SM
authors.lastname: Cobbe
authors.forename: Carola
authors.initials: C
authors.lastname: Grönhagen-Riska
authors.forename: José J
authors.initials: JJ
authors.lastname: De Lima
authors.forename: Robert
authors.initials: R
authors.lastname: Lins
authors.forename: Gert
authors.initials: G
authors.lastname: Mayer
authors.forename: Alan W
authors.initials: AW
authors.lastname: McMahon
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Parving
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Ola
authors.initials: O
authors.lastname: Samuelsson
authors.forename: Sandor
authors.initials: S
authors.lastname: Sonkodi
authors.forename: D
authors.initials: D
authors.lastname: Sci
authors.forename: Gultekin
authors.initials: G
authors.lastname: Süleymanlar
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Tsakiris
authors.forename: Vladimir
authors.initials: V
authors.lastname: Tesar
authors.forename: Vasil
authors.initials: V
authors.lastname: Todorov
authors.forename: Andrzej
authors.initials: A
authors.lastname: Wiecek
authors.forename: Rudolf P
authors.initials: RP
authors.lastname: Wüthrich
authors.forename: Mattis
authors.initials: M
authors.lastname: Gottlow
authors.forename: Eva
authors.initials: E
authors.lastname: Johnsson
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad