“Diabetic patients with end stage renal disease will usually die within 4 years, so probably it’s too late in the vascular life of the patient to [start] statin treatment.” Atorvastatin therapy does not appear to impressively lower the risk of myocardial infarction or stroke in type 2 diabetic patients with end-stage renal disease (ESRD), according to results of a large study presented last week in St. Louis at the 37th annual meeting of the American Society of Nephrology.
In the Deutsche Diabetes Dialyse Studie, or "4D Trial," investigators treated a total of 1255 type 2 diabetic patients on hemodialysis with 20 mg atorvastatin (n=619) or matching placebo (n=636) for a median of 4 years.
Study chief Dr. Christoph Wanner from University Clinic in Wuerzburg, Germany, told the audience that, "In this population, atorvastatin was very safe and effective, as seen in studies of the general population, with a mean LDL decrease of 41% that was maintained over the study period." "This is the good news of the trial," he said.
"The conservative news," he said, "is that the primary endpoint — the combined incidence of cardiac death, nonfatal MI, and stroke — did not reach statistical significance. There was an 8% risk reduction with statin therapy, which is not statistically significant."
This was a bit of a surprise, Dr. Wanner noted, given the recent findings from the CARDS trial (Collaborative Atorvastatin Diabetes Study) in which atorvastatin had significant cardioprotective effects in patients with type 2 diabetes who had not developed significant kidney disease.
In that trial, atorvastatin reduced the rate of acute coronary events by 36%, coronary revascularizations by 31%, stroke by 48%, and death by 27%.
"The ‘take-home message’ of the 4D trial is to provide statin treatment to patients with type 2 diabetes during the early stage of disease progression and not when it’s too late," Dr. Wanner said.
"Type 2 diabetics who have reached terminal renal failure and are maintained on chronic hemodialysis have the highest risk of cardiovascular death among any patient group," Dr. Wanner pointed out. "Seven out of 10 die within 4 years usually, so probably it’s too late in the vascular life of the patient to [start] statin treatment," he said. 37th annual meeting of the American Society of Nephrology.