Thursday, April 2, 2009

More Negative Statin Data in ESRD Patients

HMG coA-reductase inhibitors (a.k.a. "statins") are one of the most successful drugs in recent does not have to look far to find good, solid randomized, controlled trials touting the benefits of statin therapy in any number of patient populations. Interestingly, there is one patient population where the beneficial effect of statins does not seem to be so impressive: ESRD patients.

This was most notably demonstrated in the 2005 "4D" Study which I have mentioned in a previous post; and now in this week's New England Journal of Medicine there is another randomized control trial by Fellstrom et al demonstrating a lack of benefit of statins in dialysis patients. Briefly, over 2500 ESRD patients were randomly assigned to either placebo or 10mg of rosuvastatin. The primary outcome was a composite end-point of either MI, stroke, or cardiovascular death.  Despite having 43% lower cholesterol levels than the control group, the rosuvastatin group showed no improvement in cardiovascular events, once again arguing against a role for routine statin therapy in ESRD patients.  Interestingly, even with subgroup analysis looking at ESRD patients with known cardiovascular disease there was no benefit of statin therapy seen.

All this points to the growing suspicion that cardiovascular disease in CKD/ESRD patients may occur via a different mechanism than garden-variety atherosclerosis.  There is some data to suggest that while atherosclerosis is a disease of the intima, the cardiovascular disease of CKD/ESRD occurs at the level of medial calcification.  In addition, this study further implies that the beneficial effect of statins seen in the general population may occur independently of its cholesterol-lowering effect.

For a more in-depth analysis of this paper & its framework within the treatment of cardiovascular disease in ESRD patients, see this post on Precious Bodily Fluids.


Jim Smith said...

Yes, or starting a statin in a dialysis patient is "too little, too late." Furthermore, the study excluded any patients who had been on a statin in the previous 6 they selected a group that their healthcare providers, for whatever reason, had not felt a strong indication for a statin before the trial. One must question how this affects the generalizability of the results. I'm looking forward to the statin trials in pre-ESRD CKD patients.

Anonymous said...

I have some fundng to study the prevalence of statin use in esrd populations and interested in identifying some collaborators. I think this is an interesting and relevant topic on a variety of grounds. Practice patterns that appear to be in conflict with evidence and potential clinical impact.

Jesse M. Polansky, M.D., M.P.H.

howard dosdall said...

my statin reaction caused rhabdomyolisis w/cpk of 14,600 has left me w/nerve and muscle damage. medicare/approval came early in my life for end stage renal disease. so medicare or someone must have information that would demonstrate reason for more study in this field. 10/24/09 H