. . . .So what are we left with? I think we can confidently say after SHARP that simvastatin/ezetimibe reduces cardiovascular events in patients with CKD who do not have ESRD, and that this reduction is right in the ballpark of what we would have expected with simvastatin alone. Further, we can note that yet again a statin-based treatment showed little or no benefit in patients on hemodialysis and that there is absolutely nothing in the results from SHARP to suggest that ezetimibe provides some added clinical benefit to simvastatin alone in either patients with earlier stage CKD or patients with ESRD.
As was the case before SHARP, we have no convincing evidence that any lipid-lowering therapy added to a statin improves clinical outcomes in any patient population. . . .
Again, this conclusion is essentially what I’ve predicted — so many kidney patients (pre-dialysis) are already on statins — and it is clear that dialysis patients shouldn’t get them — so there will be very little marketing benefit to the SHARP study for Merck, even if Whitehouse Station wins an expanded label/indication.
On the sunnier side, Merck is now less than 900 days away from publishing the IMPROVE-IT outcomes trial related to Vytorin® — which, when published, will be more than eight years after it began selling the combo drug. No evidence of effectiveness, yet 8+ years of revenue, approaching $12 billion, worldwide. Wow.