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Vytorin cuts heart risk in kidney patients

Merck's Vytorin (ezetimibe/simvastatin), indicated for high cholesterol, has been shown to reduce the risk of cardiovascular problems in kidney patients, according to results of the SHARP study
Merck's Vytorin (ezetimibe/simvastatin), indicated for hypercholesterolaemia, has been shown in the SHARP study to reduce the risk of heart attacks and other cardiovascular problems by 16 per cent compared with placebo when given to kidney disease patients. The SHARP study results were presented at Renal Week 2010, this year's meeting of the American Society of Nephrology, held November 16-21 in Denver, Colorado.

The five-year SHARP study enrolled 9,438 patients who had lost at least half their kidney function (creatinine level of >1.7 mg/dL for men or >1.5 mg/dL for women). One third of enrolled patients were receiving dialysis treatment during the trial, of which none had had a previous heart attack or required bypass surgery. Patients were treated with either Vytorin or placebo.

At the end of the trial it was found that 17.9 per cent of patients receiving placebo experienced a major vascular event, compared with just 15.2 per cent of Vytorin-treated patients. There was no evidence of increased risk of cancer, muscle or liver problems and the Vytorin treatment did not appear to have any effect on progression to end-stage renal disease. 

The findings are particularly relevant as kidney disease increases the risk of cardiovascular events and earlier studies have shown mixed results regarding the benefits of cholesterol-lowering in kidney patients. Merck now plans to seek approval for Vytorin as a treatment for chronic kidney disease (CKD). 

In a company alert Merck published in light of the study results, Deutsche Bank wrote: "Results were positive overall, and no major safety concerns emerged, suggesting that [Merck] will be able to gain approval for the supplemental indication."

23rd November 2010

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