Why do we need a statin trial in hemodialysis patients?

The risk of cardiovascular complications is markedly increased in patients on dialysis treatment. This includes cardiac disease, stroke, and peripheral vascular disease. The mortality in dialysis patients is markedly higher compared to a nonuremic population. There are several cardiovascular (CV) risk factors that are unique to this population, one of which is dyslipidemia. Uremic patients do not usually develop hypercholesterolemia, but rather are characterized by high levels of very low density lipoprotein (VLDL) triglycerides, low high density lipoprotein (HDL) cholesterol, and elevated levels of modified low density lipoprotein (LDL) particles, which are particularly harmful to the vascular wall. HMG-CoA reductase inhibitors (statins) have been proven to be very efficient in reducing CV events in a nonrenal population. There are several landmark trials that have demonstrated that statins reduce the mortality in cardiovascular disease (CVD) in populations with normal, or close to normal, renal function. There are some observational registry data indicating that this may also be true in hemodialysis (HD) patients, but no prospective controlled trial has been performed to date.

We present the rationale for, and a brief outline of, a randomized placebo-controlled trial using a novel drug, rosuvastatin, in HD patients, to target cardiovascular events (the AURORA study). This study will include close to 3000 male and female HD patients, aged 50-80 years. The study is event driven and it has been estimated that it will run for a follow-up time close to four years.

There is a sound rationale for making a randomized placebo-controlled statin trial in HD patients, with the objective to demonstrate an effect on CV mortality and morbidity.