2011 Top Game Changers in Nephrology

George Bakris, MD; Jeffrey S. Berns, MD; Lynda A. Szczech, MD; Carol Peckham

Disclosures

November 16, 2011

In This Article

2. SHARP: Ezetimibe/Simvastatin Combo Cuts Atherosclerotic and Vascular Events in Kidney-Disease Patients

Final results of the Study of Heart and Renal Protection (SHARP), published in June 2011, showed that, compared with placebo, cholesterol lowering with a combination of simvastatin and ezetimibe (Vytorin®; Merck) in patients with advanced CKD significantly reduced the risk for "major atherosclerotic events" by 17% and of major vascular events -- the primary endpoint for the study -- by almost the same degree.[12] According to trial investigator Adeera Levin (University of British Columbia, Vancouver), the results should change practice by providing a clear answer to physicians, who have "been all over the map. Variability in practice was huge, and there was a lot of misunderstanding. Everyone worried that these drugs might be unsafe [in chronic kidney disease patients] and that they didn't work. Now what SHARP says is, these drugs are safe and they work." In November 2011, the Endocrinologic and Metabolic Drugs FDA Advisory Committee, chaired by Abraham Thomas (Henry Ford Hospital; Detroit, Michigan), voted 16 to 0 in favor of an expanded indication for Vytorin to reduce the risk for cardiovascular events in CKD patients not on dialysis. On the other hand, they voted 10 to 6 against the same expanded indication in end-stage renal-disease patients on dialysis.

Read the original Heartwire story on this trial and the FDA panel ruling on the ezetimibe/simvastatin combination for CKD patients.

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