Issue 182 Item 15 New Cholesterol Drug Reduces Heart Disease Marker

Ezetimib (Zetia) reduced levels of C-reactive protein by 33.3% when used in combination with simvastatin

Ezetimib (Zetia), a new cholesterol-lowering drug marketed by Merck & Co. Inc. and Schering-Plough Corp. significantly reduces levels of C-reactive protein, researchers said last week..

The clinical trial, presented at the annual meeting of the American Heart Association, showed that ezetimib reduced levels of C-reactive protein by 33.3% when used in combination with simvastatin (Zocor). This compares with a 14.3% reduction with simvastatin alone.

The trial was sponsored by Merck, which generates more than $5 billion in annual sales from Zocor, and Schering-Plough, which developed Zetia along with Merck.

The two drugs are currently marketed as separate pills, but the companies are testing them together in one pill. If the pill significantly reduces levels of both C-reactive protein as well as LDL, the companies hope it can become an important strategy in treating heart disease.

Dr. Christie Ballantyne, a Baylor College cardiologist who administered one of the sites in the clinical trial said that, "where we stand right now is that basically you want to get to the LDL target, but you don’t want to miss anything else. Now we can say that if you take Zetia and Zocor, you get the triglycerides and the LDL, but you also get the C-reactive protein drop too."

Current drugs in the widely used statin class, such as Zocor, significantly reduce LDL, the standard strategy in preventative care for heart disease.

But a gradual shift is taking place, as doctors and researchers focus on increasing levels of HDL cholesterol, reducing levels of C-reactive protein, and other strategies to augment the LDL approach.

The exact role and mechanism of C-reactive protein is still unclear, but researchers observe its presence when the body reacts to plaque around the heart by producing inflammatory proteins.

Because Zetia works by preventing the absorption of cholesterol by the intestine–as opposed to statins that operate through the liver–it can be added to low-or medium-dose statin therapy to decrease LDL significantly, rather than taking high-dose statins that could damage the liver.

However, the companies have not yet offered any conclusive data that Zetia is safer, given that statins at all doses are generally well tolerated. The data on C-reactive protein could distinguish Zetia from other drugs