Note to Correspondents
FOR IMMEDIATE RELEASE
January 8, 2009
Karen Riley, 301-796-4674
FDA Issues Update to Safety Review on Cholesterol-Lowering Drugs
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: