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Effect of rosuvastatin on outcomes in chronic haemodialysis patients: design and rationale of the AURORA study
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. (on behalf of the AURORA Study Group )
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2005 (English)In: Current controlled trials. Cardiovascular medicine (Online), ISSN 1468-6708, E-ISSN 1468-6694, Vol. 6, no 1, 9-16 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Patients with end-stage renal disease (ESRD) are at high risk of cardiovascular events. Multiple risk factors for atherosclerosis are present in ESRD and may contribute to the increased risk of cardiovascular mortality in this population. In contrast to patients with normal renal function, the benefits of modifying lipid levels on cardiovascular outcomes in patients with ESRD on haemodialysis have yet to be confirmed in large prospective randomised trials. A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events (AURORA) will be the first large-scale international trial to assess the effects of statin therapy on cardiovascular morbidity and mortality in ESRD patients on chronic haemodialysis. METHODS: More than 2,750 ESRD patients who have been receiving chronic haemodialysis treatment for at least 3 months have been randomised (1:1), irrespective of baseline lipid levels, to treatment with rosuvastatin 10 mg or placebo. The primary study endpoint is the time to a major cardiovascular event (first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Secondary endpoints include all-cause mortality, major cardiovascular event-free survival time, time to cardiovascular death, time to non-cardiovascular death, cardiovascular interventions, tolerability of treatment and health economic costs per life-year saved. Study medication will be given until 620 subjects have experienced a major cardiovascular event. CONCLUSION: Our hypothesis is that results from AURORA will establish the clinical efficacy and tolerability of rosuvastatin in patients with ESRD receiving chronic haemodialysis and guide the optimal management of this expanding population.

Place, publisher, year, edition, pages
2005. Vol. 6, no 1, 9-16 p.
Keyword [en]
atherosclerosis, cardiovascular disease, end-stage renal disease, haemodialysis, lipids, statin
National Category
Urology and Nephrology
Research subject
Medicine
Identifiers
URN: urn:nbn:se:uu:diva-105029DOI: 10.1186/1468-6708-6-9PubMedID: 15910680 OAI: oai:DiVA.org:uu-105029DiVA: diva2:220361
Available from: 2009-05-31 Created: 2009-05-31 Last updated: 2017-12-13Bibliographically approved

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