AURORA, 2009 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of rosuvastatin versus placebo in in patients with end-stage renal disease on hemodialysis

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N Engl J Med 2009;360:1395-407
 



Studied treatment rosuvastatin 10 mg daily
Control treatment placebo



Patients in patients with end-stage renal disease on hemodialysis
Group sizes1391 / 1385
Inclusion criteriaage 50-80 years patients with end-stage renal disease receiving hemodialysis for at least 3 months
Exclusion criteriastatin therapy within the last 6 month; expected kidney transplant within 1 year; life expectancy <1 year; history of malignancy; alanine aminotransferase >3x the ULN; uncontrolled hyperthyroidism; unexplained elevation in creatine kinase >3x the ULN
Diabetes (%)



Blindness double blind Inclusion period jan 2003 - dec 2004
Follow-up duration 3.2 y mean (max 5.6y) Centers
Lost to FU geographical localisation
Primary endpoint cardiovascular death, nonfatal MI, or nonfatal stroke Design Parallel groups
PeriodeInclusionjan 2003 - dec 2004



EndpointX1N1X0N0TE95% CI cardiovascular death, CV events (nonfatal MI, or nonfatal stroke) 396 1391 408 1385 0,97[0,82; 1,14] Thrombosis of hemodialysis vascular access - 1391 - 1385 no data CV events - 1391 - 1385 no data Cardiovascular death 324 1391 324 1385 1,00[0,84; 1,19] Coronary or peripheral revascularization 148 1391 152 1385 0,97[0,76; 1,23] all cause death 636 1391 660 1385 0,96[0,83; 1,11] Noncardiovascular death 248 1391 268 1385 0,92[0,76; 1,12] coronary events - 1391 - 1385 no data0,22,01,0

Fellstrom BC, Jardine AG, Schmieder RE, et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis N Engl J Med 2009;360:1395-407.     [PMID: 19332456]   link to pdf   add to Mendeley  

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 Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009;360:1395-407     [PMID: 19332456]   link to pdf   add to Mendeley  



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