1. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.
- Author
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Fellström BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Grönhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Süleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wüthrich RP, Gottlow M, Johnsson E, and Zannad F
- Subjects
- Aged, Aged, 80 and over, C-Reactive Protein analysis, Cardiovascular Diseases mortality, Cholesterol blood, Double-Blind Method, Female, Fluorobenzenes adverse effects, Follow-Up Studies, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Kaplan-Meier Estimate, Kidney Failure, Chronic blood, Kidney Failure, Chronic mortality, Kidney Failure, Chronic therapy, Male, Middle Aged, Prospective Studies, Pyrimidines adverse effects, Rosuvastatin Calcium, Sulfonamides adverse effects, Treatment Failure, Cardiovascular Diseases prevention & control, Fluorobenzenes therapeutic use, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Kidney Failure, Chronic drug therapy, Pyrimidines therapeutic use, Renal Dialysis adverse effects, Sulfonamides therapeutic use
- 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.), (2009 Massachusetts Medical Society)
- Published
- 2009
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