CV Risk Persists in Atorvastatin Tx of Type 2 Diabetics on Dialysis


ST. LOUIS — Type 2 diabetic patients with kidney failure or end-stage renal disease had significant reductions in LDL cholesterol, but not cardiac death, MI, or stroke, after an average of 4 years of treatment with atorvastatin, Christoph Wanner, M.D., reported at the annual meeting of the American Society of Nephrology.

“We reached the goal of reducing LDL [cholesterol] by 41% in type 2 diabetic patients with kidney failure or end-stage renal disease. In addition, safety was excellent in this patient population,” said Dr. Wanner, professor of medicine and head of nephrology at the University Clinic, Würzburg, Germany.

For this prospective, randomized, double-blind study, Dr. Wanner and his associates enrolled 1,255 patients at 178 dialysis centers in Germany between 1998 and 2004. They randomized patients to 20 mg of atorvastatin (619 patients) or placebo (636 patients) for a median of 4 years.

The trial, known as the Deutsche Diabetes Dialyse Studie, and also referred to as the 4D Trial, is the first examination of statin therapy in patients with type 2 diabetes and kidney failure. It also is the first study of cardiovascular outcomes among dialysis patients taking statins, Dr. Wanner said. All study participants had advanced-stage type 2 diabetes and were on maintenance hemodialysis. Some patients also had complications of diabetes including retinopathy, degenerative nerve disease, blindness, and diabetic gangrene, the researchers reported. Among the study participants, between 20% and 30% had a history of prior MI, revascularization, and/or heart surgery.

The investigators noted that the 41% reduction in LDL cholesterol in their study patients taking atorvastatin was consistent with data obtained previously in the general population.

But there was one important difference between the participants in their study and those in previous studies such as the Collaborative Atorvastatin Diabetes Study. Patients in the 4D Trial did not have statistically significant reductions in risk of cardiac death, myocardial infarction, and stroke.

“Importantly, this trial suggests that statins are not as effective in dialysis patients. Randomized trials will be necessary if we really want to begin to treat these patients appropriately,” David Charytan, M.D., said in an interview with this newspaper. Dr. Charytan, who is a clinical and research fellow at Brigham and Women's Hospital, Boston, was another presenter at the meeting.

Because of this difference in response to statin drugs, patients with type 2 diabetes should be treated with statin therapy early on, before the onset of renal disease, Dr. Wanner concluded.

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