• DOI:10.1056/NEJMoa0810177
• Corpus ID: 28248690

Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

@article{Fellstrm2009RosuvastatinAC,
  title={Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.},
  author={Bengt C. Fellstr{\"o}m and Alan G. Jardine and Roland E. Schmieder and Hallvard Holdaas and Kym M. Bannister and Jaap J. Beutler and Dong-wan Chae and Alejandro Chevaile and Stuart M. Cobbe and Carola Gr{\"o}nhagen-Riska and Jose Jayme G. De Lima and Robert L. Lins and Gert Mayer and Alan W. McMahon and HANS-HENRIK D. Parving and Giuseppe Remuzzi and Ola Samuelsson and S{\'a}ndor Sonkodi and D Sci and G{\"u}ltekin S{\"u}leymanlar and Dimitrios J Tsakiris and V. Tesar and Vasil V. Todorov and Andrzej Więcek and Rudolf P W{\"u}thrich and Mattis Gottlow and Eva Johnsson and Faiez Zannad},
  journal={The New England journal of medicine},
  year={2009},
  volume={360 14},
  pages={
          1395-407
        }
}

• B. Fellström, A. Jardine, +25 authors F. Zannad
• Published 2 April 2009
• Medicine
• The New England journal of medicine

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.)