Statin Does Not Prevent Cardiac Events in Seriously Ill Patients With Type 2 Dia

The investigators speculate that this may be too late in the disease course for therapy to be beneficial. "Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus," write Christoph Wanner, MD, from the University of Würzburg in Germany, and colleagues. "However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined."

In this double-blind, prospective study, 1,255 patients with type 2 DM receiving maintenance hemodialysis were randomized to receive 20 mg of atorvastatin per day or matching placebo. The primary outcome measure was a composite of death from cardiac causes, nonfatal myocardial infarction (MI), and stroke; and secondary outcomes included death from all causes and all cardiac and cerebrovascular events combined. Median duration of follow-up was four years.

After four weeks of treatment, the median level of low-density lipoprotein (LDL) cholesterol decreased by 42% in the atorvastatin group and by 1.3% in the placebo group. "Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis," the authors write. "Of nominal significance, more cases of fatal stroke occurred in the atorvastatin group (27) than in the placebo group (13). This finding is unexplained and could be a chance finding, particularly in view of the data from CARDS [the Collaborative Atorvastatin Diabetes Study], which indicate that atorvastatin lowers the incidence of stroke."
"In persons with type 2 diabetes mellitus who are receiving maintenance hemodialysis and have LDL cholesterol values between 80 and 190 mg per deciliter, routine treatment with a statin to reduce the primary composite end point of death from cardiac causes, myocardial infarction, and stroke is not warranted," the authors conclude. "The initiation of lipid-lowering therapy in patients with type 2 diabetes mellitus who already have end-stage renal disease may come too late to translate into consistent improvement of the cardiovascular outcome."

Patients with type 2 DM who are receiving hemodialysis have a higher annual incidence of CHD mortality, at 8.2%, than other patients with cardiovascular risk factors. The use of atorvastatin for 4 years in patients with type 2 DM who are receiving hemodialysis and who have LDL cholesterol levels between 80 and 190 mg/dL does not improve survival or cardiovascular endpoints.

N Engl J Med 2005;353:238-248

================================

DID YOU KNOW:

Ranbaxy Pharmaceuticals Inc. announced it has received tentative approval from the U.S. Food and Drug Administration to manufacture and market glimepiride tablets, 1 mg, 2 mg, 4 mg, and 8 mg, generic for Amaryl®. Product will be launched following final approval from the FDA on October 6, 2005.