Patients Receiving Haemodialysis For Treatment Of End Stage Renal Disease Did Not Benefit From Statin Therapy In The AURORA Study

Main Category: Urology / Nephrology
Also Included In: Statins;  Clinical Trials / Drug Trials
Article Date: 01 Apr 2009 - 0:00 PDT

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New data from the AURORA trial, a study in patients with end stage renal disease (ESRD) undergoing chronic haemodialysis, showed that there was no difference between rosuvastatin 10mg and placebo in reducing the combined endpoint of cardiovascular (CV) death, nonfatal stroke, and nonfatal myocardial infarction. During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 in the placebo group reached the primary end point (p=0.59). These new data were presented at the 58th Annual American College of Cardiology Scientific Sessions (ACC) in Orlando, Florida, and published simultaneously in the New England Journal of Medicine.

This result from the AURORA study is in line with the previously published 4D study that investigated the use of atorvastatin in patients undergoing haemodialysis.

Patients with ESRD have kidney (renal) failure, requiring dialysis, and have advanced calcification of the arteries. To stay alive these patients must have their blood cleaned artificially by dialysis or receive a new kidney through transplantation. Patients with ESRD undergoing chronic haemodialysis have an increased cardiovascular mortality compared to people with normal renal function.

In over 2,700 chronically sick patients in AURORA, the frequency of adverse events was similar among those taking rosuvastatin and placebo.

"These chronically ill patients with kidney failure have advanced calcification of the arteries which makes those arteries stiff and unable to function normally," said Michael Cressman, AstraZeneca's Medical Science Director for CRESTOR, "The lack of observed benefit with statin therapy in 4D and AURORA suggests that CV disease in these patients receiving chronic haemodialysis differs from that in other clinical settings."

AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events) is a large-scale, international, randomized, double-blind, placebo-controlled study comparing CRESTOR 10mg and placebo on CV death, nonfatal stroke and nonfatal MI in 2,750 patients with end-stage renal disease (ESRD) on chronic haemodialysis. AURORA was conducted in 25 countries.

AURORA is part of AstraZeneca's extensive GALAXY clinical trials program, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Program.

About Rosuvastatin

Studies have previously shown that CRESTOR significantly lowered LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.

CRESTOR has now received regulatory approval in over 95 countries. Nearly 15 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: http://www.astrazeneca.com

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AstraZeneca