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