The FDA has reaffirmed its position that elevated LDL is a risk factor for heart attack, stroke, and sudden death, among other cardiovascular diseases, and that reducing LDL levels lowers the risk of these diseases.
The comments updated a January 25, 2008, Early Communication describing the agency’s review of data from the ENHANCE clinical trial that compared Zocor (simvastatin) and Vytorin, a combination drug consisting of Zocor and Zetia (ezetimibe).
Completing its review of the final clinical trial report of ENHANCE, the FDA stated that after two years of treatment, there was no significant difference in carotid artery thickness between Vytorin-treated patients and Zocor-treated patients, but LDL decreased by 56% in the Vytorin group and decreased by 39% in the Zocor group.
The FDA’s position on the benefits of lowering LDL remains unchanged. The update is available at www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin200901.htm, accessed February 17, 2009.