International researchers will, for the first time, present findings from the landmark 4D trial about whether a cholesterol-reducing drug decreases the risk of heart attacks and strokes with type 2 diabetics on dialysis at the American Society of Nephrology’s 37th Annual Meeting and Scientific Exposition in St. Louis, Missouri.
The 4D trial is the first study to examine the use of statins in type 2 diabetics with kidney failure or end-stage renal disease (ESRD), as well as to study cardiovascular outcomes in dialysis patients overall. “The findings will contribute to the understanding of the mechanisms of cardiovascular disease in type 2 diabetics on hemodialysis treatment and will help to guide treatment options,” says lead author of the study, Christoph Wanner, professor of medicine and chief of the nephrology division at the University Clinic, Wuerzburg, Germany.
The recent ASCOT and CARDS trials have demonstrated that atorvastatin provides significant cardiovascular benefits in patients with type 2 diabetes who do not yet have significant kidney disease and suggest that these patients be treated early with preventive therapy to lower their cardiovascular risk. The 4D trial findings will show whether the use of atorvastatin is also beneficial in type 2 diabetics who have progressed to kidney failure where hemodialysis is the only option to keep them alive.
The ‘Deutsche Diabetes Dialyse Studie” (4D study) is a prospective, randomized, double-blind study involving 1255 patients at 178 dialysis centers throughout Germany who took either 20 mg of atorvastatin or placebo between 1998 through February 2004. The study examines the effectiveness and safety of atorvastatin, an HMG-CoA reductase inhibitor (HMGRI), in patients with type 2 diabetes on maintenance hemodialysis.
As is typical for patients with end-stage kidney disease (ESRD), a large proportion of patients in the trial suffered from other diseases, such as hypertension, congestive heart failure, peripheral artery disease and cardiac disease. Between 20 and 30 percent had suffered a prior heart attack or had undergone revascularization and heart surgery. All patients suffered from advanced stage diabetes, including retinopathy, degenerative nerve disease, blindness, and diabetic gangrene.