Statins in CKD: the 4D Study & More.

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Cardiovascular disease is by far and away the #1 killer for patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD_. Therefore, HMG coA reductase inhibitors (a.k.a. “statins”)–with their impressive track record of clinical trials showing a benefit for patients with cardiovascular disease–would seem to be a natural choice for kidney patients.

However the most extensive randomized control trial on the subject appears to suggest otherwise. The results of the surprising “4D Study” (standing for Deutsche Diabetes Dialyse Studie) were published in 2005; the study was a double-blind, placebo controlled trial that randomized over a thousand patients with ESRD and T2DM to either lipitor 20mg or placebo. Although the statin-receiving group did show a lowering of cholesterol, this failed to translate into any improved endpoints in cardiovascular death, non-fatal MI, or stroke. This has led to speculation that perhaps the mechanism by which cardiovascular disease occurs in dialysis patients is different from the standard “cholesterol plaque rupture” model which has become the current model.

The case for statins in CKD is not completely closed–there are some more recent studies which have retrospectively looked at other large statin studies (e.g., the famous “4S Study”) and looked to see how kidney patients fared, and they suggest that there may be some benefit to statins. So the jury is still out.

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