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HEALTH

FDA approves two-in-one cholesterol-lowering drug

Although promoted as a first-line drug, some say Vytorin may be best used by people unable to tolerate high-dose statins.

By Susan J. Landers, amednews staff. Aug. 16, 2004.

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Washington -- Two pharmaceutical companies are set to begin marketing a new blended medication they say lowers harmful LDL cholesterol as sharply as the most popular high-dose statin alone.

Vytorin (ezetimibe/simvastatin) was approved by the Food and Drug Administration July 23 and is expected to be available by Labor Day at the latest, said company officials.

The new medication is a combination of Schering-Plough's Zetia (ezetimibe) which blocks the absorption of cholesterol in the intestines and Merck & Co. Inc.'s Zocor (simvastatin), a traditional statin that cuts cholesterol production in the liver.

Cholesterol-lowering medication in general is attracting additional interest since an updated version of federal cholesterol guidelines was released last month. Citing new research on the health benefits of lowering LDL cholesterol, this latest round of recommendations offers physicians the option of striving for even lower LDL levels among patients at high risk for heart attacks.

The guidelines lowered target levels from 100 mg/dL, to 70 mg/dL for patients who have coronary heart disease or diabetes or for those who smoke and have hypertension.

The change in advice could add millions of additional patients to the enormous group already taking cholesterol medication, predominately statins.

Thus, Vytorin's introduction is expected to touch off a price and advertising war in the profitable multibillion dollar anticholesterol drug market.

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