AURORA trial
Encyclopedia
The AURORA trial was a randomized
, double-blind
, placebo-controlled study investigating the use of rosuvastatin
in the prevention of cardiovascular disease
among patients undergoing chronic hemodialysis.
The trial was undertaken because although patients with end-stage renal disease (ESRD) are at high risk of adverse cardiovascular events, no large clinical trial had confirmed the benefit of lipid
lowering agents. The AURORA trial sought to fill this gap.
The trial was conducted across 280 medical centers in 25 countries. The study randomized 2776 patients, aged 50–80 years and undergoing maintenance hemodialysis
, to one of two groups. One group received rosuvastatin 10 mg daily and the other group received a placebo
. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction
, or nonfatal stroke
. Although the mean LDL cholesterol was reduced by 43% in the rosuvastatin arm of the study at three months, no difference in the primary end point was demonstrated at an average follow-up of 3.8 years.
The trial was sponsored, in part, by AstraZeneca
, the marketer of Crestor.
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
, double-blind
Double-blind
A blind or blinded experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, invalidating the results....
, placebo-controlled study investigating the use of rosuvastatin
Rosuvastatin
Rosuvastatin is a member of the drug class of statins, used to treat high cholesterol and related conditions, and to prevent cardiovascular disease. It was developed by Shionogi.-Medical uses:The primary uses of rosuvastatin is for the treatment of dyslipidemia...
in the prevention of cardiovascular disease
Cardiovascular disease
Heart disease or cardiovascular disease are the class of diseases that involve the heart or blood vessels . While the term technically refers to any disease that affects the cardiovascular system , it is usually used to refer to those related to atherosclerosis...
among patients undergoing chronic hemodialysis.
The trial was undertaken because although patients with end-stage renal disease (ESRD) are at high risk of adverse cardiovascular events, no large clinical trial had confirmed the benefit of lipid
Lipid
Lipids constitute a broad group of naturally occurring molecules that include fats, waxes, sterols, fat-soluble vitamins , monoglycerides, diglycerides, triglycerides, phospholipids, and others...
lowering agents. The AURORA trial sought to fill this gap.
The trial was conducted across 280 medical centers in 25 countries. The study randomized 2776 patients, aged 50–80 years and undergoing maintenance hemodialysis
Hemodialysis
In medicine, hemodialysis is a method for removing waste products such as creatinine and urea, as well as free water from the blood when the kidneys are in renal failure. Hemodialysis is one of three renal replacement therapies .Hemodialysis can be an outpatient or inpatient therapy...
, to one of two groups. One group received rosuvastatin 10 mg daily and the other group received a placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction
Myocardial infarction
Myocardial infarction or acute myocardial infarction , commonly known as a heart attack, results from the interruption of blood supply to a part of the heart, causing heart cells to die...
, or nonfatal stroke
Stroke
A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...
. Although the mean LDL cholesterol was reduced by 43% in the rosuvastatin arm of the study at three months, no difference in the primary end point was demonstrated at an average follow-up of 3.8 years.
The trial was sponsored, in part, by AstraZeneca
AstraZeneca
AstraZeneca plc is a global pharmaceutical and biologics company headquartered in London, United Kingdom. It is the world's seventh-largest pharmaceutical company measured by revenues and has operations in over 100 countries...
, the marketer of Crestor.