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.
Cardiovascular disease is the leading cause of death among patients with kidney failure or end stage renal disease (ESRD). Cardiovascular damage begins as soon as the kidney looses function and increases in severity during the progression of kidney disease. Patients with type 2 diabetes who require dialysis, due to kidney failure, are about 30 times more likely to die of cardiovascular disease, including heart attacks and strokes, than the general population.
The study, “Results of a Randomized Controlled Trial with Atorvastatin in Dialyzed Diabetic Patients (4D trial)” will be presented during the Basic and Clinical Science Symposia, “Atherosclerosis: A Different Disease in CKD than in the General Population” on Friday, October 29 from 1:30 – 3:30 PM in Hall 5 of the America’s Center.
The ASN is a not-for-profit organization of 9,000 physicians and scientists dedicated to the study of nephrology and committed to providing a forum for the promulgation of information regarding the latest research and clinical findings on kidney diseases. ASN’s Renal Week 2004, the largest nephrology meeting of its kind, will provide a forum for more than 12,000 nephrologists to discuss the latest findings in renal research and engage in educational sessions relating advances in the care of patients with kidney and related disorders from October 27- November 1, 2004 at the America’s Center in St. Louis, Missouri.