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Vytorin Protects Chronic Kidney Disease Patients From Major Vascular Events

April 21, 2017

Experimental drug Vytorin (ezetimibe/simvastatin) was found to lower the risk of major vascular events by 16.1% compared to a placebo for patients with chronic kidney disease, Merck & Co announced today. Vytorin is a cholesterol lowering medication. Examples of major vascular events are non-fatal heart attacks, stroke or any type of revascularization procedure.

Ezetimibe/simvastatin is currently approved for patients with primary hypercholesterolemia or mixed hyperlipidemia. Merck says it will seek approval for patients with chronic kidney disease following the positive results of its latest trial.

The trial - SHARP (Study of Heart and Renal Protection) - included 9,000 advanced or end-stage chronic kidney disease patients. Merck says it is the first prospective clinical study with such patients that demonstrates the benefit of reducing LDL cholesterol* on major vascular events.

* LDL cholesterol, or Low Density Lipoprotein, is often referred to as bad cholesterol. LDL carries cholesterol from the liver to cells. If more LDL is carried than the cells need, there may be a harmful accumulation of LDL. If levels are too high there is a risk of arterial disease. Most human blood carries approximately 70% LDL, however this may vary.

Professor Colin Baigent, F.F.P.H., F.R.C.P., and Dr. Martin Landray, Ph.D., F.R.C.P., the principal investigators of SHARP, from the Oxford University Clinical Trial Service Unit (CTSU), Oxford, England, said: "This is an important study," said Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories. "Patients with CKD have a high risk of ischemic vascular disease and increased rates of heart attack, stroke, other cardiovascular events and revascularization procedures. In SHARP, the investigational use of Vytorin significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease - and this was the first demonstration that an LDL-cholesterol lowering medicine could do so." The study was presented at the annual meeting of the American Society of Nephrology in Denver.

Merck informs that Vytorin should not be taken by patients with active liver disease or unexplained persistent elevations of serum transaminases. The medication should not be taken by women of childbearing age unless they are sure they are not going to conceive, nursing mothers, or pregnant mothers.

The study's primary endpoint was to see whether Vytorin could lower major vascular event risk in patients with chronic kidney disease by bringing down LDL cholesterol levels. It is known that chronic kidney disease patients have a higher risk of cardiovascular disease, but nobody was sure whether reducing LDL cholesterol levels might have an impact on the risk.

Previous studies using statins on patients with end-stage kidney disease who were on dialysis showed no such benefit. In the SHARP study, two-thirds of the participants were not on dialysis initially. Half of the 9,000 patients were given a placebo and the other half Vytorin. They were monitored for approximately 4 years (average). 701 (15%) of the those in the Vytorin group had a major vascular event compared to 814 (18%) in the placebo group.

Ezetimibe/simvastatin is a medication combination for the treatment of high cholesterol and/or fats in the blood (dyslipidemia). It is a combination of ezetimibe and simvastatin. Ezetimibe is known as Zetia in the USA and Ezetrol in other countries. Simvastatin is commonly known as Zocor in the USA. The combination preparation is marketed through a joint venture by Merck & Co and Schering-Plough under the trade names Inegy and Vytorin.

View drug information on Zocor.