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FDA Issues Update to Safety Review on Cholesterol-Lowering Drugs

January 12, 2009 -- The U.S. Food and Drug Administration today reaffirmed its position that elevated amounts of low-density lipoprotein (LDL), or “bad cholesterol,” are a risk factor for cardiovascular diseases such as heart attack, stroke and sudden death and that lowering LDL cholesterol reduces the risk of these diseases.

FDA's comments are contained in an update to its Jan. 25, 2008, Early Communication describing the agency’s review of data from ENHANCE, a clinical trial comparing Zocor (simvastatin), a drug that lowers cholesterol production in the liver, to Vytorin, a drug that combines Zocor with another drug, Zetia (ezemtimibe), which inhibits cholesterol absorption.

Preliminary results from ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) had indicated there was no significant difference between Vytorin and Zocor-treated patients in the thickness of the walls of the blood vessels of the neck (the carotid arteries) although there was greater lowering of the amount of LDL cholesterol in patients with Vytorin compared to Zocor.

Measuring the thickness of the carotid arteries via ultrasound imaging is considered a biomarker of risk for cardiovascular disease.

FDA has now completed its review of the final clinical trial report of ENHANCE. After two years of treatment, there was no significant difference in carotid artery thickness between Vytorin patients and Zocor patients. However, the levels of LDL cholesterol, decreased by 56% in the Vytorin group and decreased by 39% in the Zocor group.

The results from ENHANCE do not change FDA’s position on the benefits of lowering LDL cholesterol. Based on currently available data, patients should not stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health care professional if they have any questions about Vytorin, Zetia or the ENHANCE trial.

FDA’s Early Communications are disclosures that the agency has begun evaluating new data about a drug and is considering regulatory action, but has yet to reach a conclusion.

The update is posted on FDA’s Web site at: https://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin200901.htm.

Source: Food and Drug Administration

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