Rosuvastatin and cardiovascular events in patients undergoing hemodialysis

Bengt C. Fellström, Alan G. Jardine, Roland E. Schmieder, Hallvard Holdaas, Kym Bannister, Jaap Beutler, Dong Wan Chae, Alejandro Chevaile, Stuart M. Cobbe, Carola Grönhagen-Riska, José J. De Lima, Robert Lins, Gert Mayer, Alan W. McMahon, Hans Henrik Parving, Giuseppe Remuzzi, Ola Samuelsson, Sandor Sonkodi, Gultekin Süleymanlar, Dimitrios TsakirisVladimir Tesar, Vasil Todorov, Andrzej Wiecek, Rudolf P. Wüthrich, Mattis Gottlow, Eva Johnsson, Faiez Zannad

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Abstract

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.)

Original languageEnglish
Pages (from-to)1395-1407
Number of pages13
JournalNew England Journal of Medicine
Volume360
Issue number14
DOIs
Publication statusPublished - Apr 2 2009

ASJC Scopus subject areas

  • Medicine(all)

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    Fellström, B. C., Jardine, A. G., Schmieder, R. E., Holdaas, H., Bannister, K., Beutler, J., Chae, D. W., Chevaile, A., Cobbe, S. M., Grönhagen-Riska, C., De Lima, J. J., Lins, R., Mayer, G., McMahon, A. W., Parving, H. H., Remuzzi, G., Samuelsson, O., Sonkodi, S., Süleymanlar, G., ... Zannad, F. (2009). Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. New England Journal of Medicine, 360(14), 1395-1407. https://doi.org/10.1056/NEJMoa0810177