Authors

Fellström BC, Jardine AG, Schmieder RE, et al.

Title

Rosuvastatin and cardiovascular events in paients undergoing hemodialysis.

References

N Engl J Med. 2009 Apr 2;360(14):1395-407

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.

Purpose

To investigate the effects of statin therapy in patients undergoing regular hemodialysis treatment.

Design

Multicenter, randomized, double-blind, placebo controlled trial
2776 patients ages 50-80 years who were undergoing maintenance hemodialysis for at least 3 months

Exclusion Criteria

Statin therapy within the previous 6 months
Expected kidney transplant within 1 year
Any serious medical condition that would limit life expectancy <1 year
ALT >3x ULN
Uncontrolled hypothyroidism
CK >3x ULN

Follow-Up

Median 3.8 years

Treatment Regimen

Rosuvastatin 10mg/day or placebo
Follow up visits 3 months after enrolment and then 6 months thereafter. Assessments included routine blood work and clinical interview

Results

Primary Endpoints

Rosuvastatin
n=1389
no. of events/100 patient-yr Placebo
n=1384
no. of events/100 patient-yr Hazard Ratio p

Combined outcome (major CV event)

9.2 9.5 0.96 (0.84-1.11) 0.59

CV death

7.2 7.3 1.00 (0.85-1.16) 0.97

Non-fatal MI

2.1 2.5 0.84 (0.64-1.11) 0.42

Non-fatal stroke

1.2 1.1 1.17 (0.79-1.75) 0.42

Secondary Outcomes

(see study for complete list)

Rosuvastatin
n=1389
no. of events/100 patient-yr Placebo
n=1384
no. of events/100 patient-yr Hazard Ratio p

Death – any cause

13.5 14.0 0.96 (0.86-1.07) 0.51

Non-fatal MI

1.7 2.3

Non-fatal stroke

1.0 0.9

Summary

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.