Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis
Bengt C. Fellström, M.D., Ph.D., Alan G. Jardine, M.D., Roland E. Schmieder, M.D., Hallvard Holdaas, M.D., Ph.D., Kym Bannister, M.D., Jaap Beutler, M.D., Ph.D., Dong-Wan Chae, M.D., Ph.D., Alejandro Chevaile, M.D., Stuart M. Cobbe, M.D., Carola Grönhagen-Riska, M.D., Ph.D., José J. De Lima, M.D., Ph.D., Robert Lins, M.D., Ph.D., Gert Mayer, M.D., Alan W. McMahon, M.D., Hans-Henrik Parving, M.D., D.M.Sc., Giuseppe Remuzzi, M.D., Ola Samuelsson, M.D., Ph.D., Sandor Sonkodi, M.D., Ph.D., D. Sci., Gultekin Süleymanlar, M.D., Dimitrios Tsakiris, M.D., Ph.D., Vladimir Tesar, M.D., Ph.D., Vasil Todorov, M.D., Ph.D., Andrzej Wiecek, M.D., Ph.D., Rudolf P. Wüthrich, M.D., Mattis Gottlow, M.Sc., Eva Johnsson, M.D., Ph.D., Faiez Zannad, M.D., Ph.D., for the AURORA Study Group
Background Statins reduce the incidence of cardiovascular eventsin patients at high cardiovascular risk. However, a benefitof statins in such patients who are undergoing hemodialysishas not been proved.
Methods We conducted an international, multicenter, randomized,double-blind, prospective trial involving 2776 patients, 50to 80 years of age, who were undergoing maintenance hemodialysis.We randomly assigned patients to receive rosuvastatin, 10 mgdaily, or placebo. The combined primary end point was deathfrom cardiovascular causes, nonfatal myocardial infarction,or nonfatal stroke. Secondary end points included death fromall 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 mmolper liter). During a median follow-up period of 3.8 years, 396patients in the rosuvastatin group and 408 patients in the placebogroup reached the primary end point (9.2 and 9.5 events per100 patient-years, respectively; hazard ratio for the combinedend point in the rosuvastatin group vs. the placebo group, 0.96;95% confidence interval [CI], 0.84 to 1.11; P=0.59). Rosuvastatinhad 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 initiationof treatment with rosuvastatin lowered the LDL cholesterol levelbut had no significant effect on the composite primary end pointof death from cardiovascular causes, nonfatal myocardial infarction,or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331
[ClinicalTrials.gov]
.)
Source Information
The affiliations of the authors are listed in the Appendix. This article (10.1056/NEJMoa0810177) was published at NEJM.org on March 30, 2009.
Address reprint requests to Dr. Fellström at the Department of Medical Science, Renal Unit, University Hospital, SE-751 85, Uppsala, Sweden, or at bengt.fellstrom{at}medsci.uu.se.
Rosuvastatin in Patients Undergoing Hemodialysis
Ganguli A., Kassimatis T. I., Konstantinopoulos P. A., de Oliveira J. M. F., Fellström B., Jardine A., Holdaas H., the AURORA Executive Steering Committee
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N Engl J Med 2009;
361:93-95, Jul 2, 2009.
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