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SHARP: Simvastatin plus ezetimibe linked with fewer atherosclerotic events

Baigent C. Lancet. 2011;doi:10.1016/S0140-6736(11)60822-2.

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In patients with chronic kidney disease, a combination of simvastatin 20 mg plus ezetimibe 10 mg given daily was associated with a significant reduction in atherosclerotic events, results from the SHARP study indicated.

Researchers for the study enrolled 9,270 patients with chronic kidney disease and a known history of MI or coronary revascularization. Patients were randomly assigned to receive either simvastatin (Zocor, Merck) 20 mg daily plus ezetimibe (Zetia, Merck) 10 mg daily (n=4,650) or matching placebo (n=4,620). The primary endpoint was the first major atherosclerotic event (nonfatal MI or coronary death, non-hemorrhagic stroke or any revascularization).

According to the results, patients in the combined therapy group had an average LDL difference of 0.85 mmol/L during the median follow-up of 4.9 years, which produced a 17% proportional reduction in major atherosclerotic events (11.3%) vs. placebo (13.4%, P=.0021). Fewer patients receiving the combined therapy died from CHD (4.6% vs. 5.0%), and there were also reductions in non-hemorrhagic stroke (2.8% vs. 3.8%) and arterial revascularization procedures (6.1% vs. 7.6%) vs. placebo, but these reductions did not attain statistical significance.

“The SHARP randomized trial has now shown that lowering of LDL cholesterol with simvastatin plus ezetimibe safely reduces the risk of major atherosclerotic events in a wide range of patients with chronic kidney disease,” the researchers wrote in their interpretation of the results. “When the SHARP results are compared with those of previous statin trials in renal patients, it appears that the absence of significant reductions in earlier trials could have been due both to the much smaller number and the much smaller proportion of vascular events in the primary outcomes that were related to atherosclerosis and, hence, preventable by lowering of LDL cholesterol.”

Disclosure: The SHARP trial received funding from Merck/Schering-Plough.

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