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.)