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ABSTRACT

Background Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined.

Methods We conducted a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis who were randomly assigned to receive 20 mg of atorvastatin per day or matching placebo. The primary end point was a composite of death from cardiac causes, nonfatal myocardial infarction, and stroke. Secondary end points included death from all causes and all cardiac and cerebrovascular events combined.

Results After four weeks of treatment, the median level of low-density lipoprotein cholesterol was reduced by 42 percent among patients receiving atorvastatin, and among those receiving placebo it was reduced by 1.3 percent. During a median follow-up period of four years, 469 patients (37 percent) reached the primary end point, of whom 226 were assigned to atorvastatin and 243 to placebo (relative risk, 0.92; 95 percent confidence interval, 0.77 to 1.10; P=0.37). Atorvastatin had no significant effect on the individual components of the primary end point, except that the relative risk of fatal stroke among those receiving the drug was 2.03 (95 percent confidence interval, 1.05 to 3.93; P=0.04). Atorvastatin reduced the rate of all cardiac events combined (relative risk, 0.82; 95 percent confidence interval, 0.68 to 0.99; P=0.03, nominally significant) but not all cerebrovascular events combined (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49) or total mortality (relative risk, 0.93; 95 percent confidence interval, 0.79 to 1.08; P=0.33).

Conclusions Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.

Source Information

From the Department of Medicine, Division of Nephrology, University of Würzburg, Würzburg, Germany (C.W., V.K.); the Clinical Institute of Medical and Chemical Laboratory Diagnostics, University General Hospital, Graz, Austria (W.M.); the Department of Medical Biometrics and Statistics, University Hospital of Freiburg, Freiburg, Germany (M.O.); Schwabing General Hospital, Munich, Germany (J.F.E.M.); Clinical Research Department, Pfizer, Karlsruhe, Germany (G.R.); and the Department of Medicine, University of Heidelberg, Heidelberg, Germany (E.R.).

Address reprint requests to Dr. Wanner at the Department of Medicine, Division of Nephrology, University Hospital, Josef-Schneider-Str. 2, D-97080 Würzburg, Germany, or at wanner_c{at}medizin.uni-wuerzburg.de.

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Atorvastatin in Patients with Type 2 Diabetes Mellitus Undergoing Dialysis
Langer A., Robinson J. G., Jaber B. L., Madias N. E., Wanner C., Krane V., Ritz E.
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N Engl J Med 2005; 353:1858-1860, Oct 27, 2005. Correspondence

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