Zetia Does Not Reduce Carotid Plaque Size When Added To Zocor
Zetia (ezetimibe) "may not actually prevent heart attacks and strokes," according to the long-awaited results of the Enhance trial. Typically, patients "take Zetia in the form of Vytorin (ezetimibe and simvastatin), which combines Zetia with Zocor (simvastatin)." Zetia and Vytorin are jointly marketed by Merck & Co. and Schering-Plough Corp.
Zetia reduces cholesterol 15 to 20 percent in most patients, no trial has been completed yet that has ever shown that it can reduce heart attacks and strokes -- or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems. The Enhance trial "was designed to show that Zetia could reduce the growth" of fatty plaques in arteries. However, "the plaques actually grew by 0.005 mm more in those taking Zetia along with Zocor than in those taking Zocor alone."
The trial was conducted by a group headed by Dr. John J.P. Kastelein of the University of Amsterdam Medical Center. All 720 participants suffered from an unusual condition known as heterozygous familial hypercholesterolemia. Vytorin cut "LDL levels by 58 percent, compared to a 41 percent reduction with simvastatin alone. However, the researchers found that "the average thickness of the carotid artery plaque increased by 0.0111 of a millimeter in patients taking Vytorin, compared to an increase of 0.0058 of a millimeter in" those taking only simvastatin.
According to Dr. Norman Lepor, Westside Medical Associates of Los Angeles and an expert on the treatment of hyperlipidemia, "The complete clinical trial results will be researchers plan to present their data in March at a meeting of the American College of Cardiology." He also said that "one should not confuse the very, very small increase in carotid plaque dimension with a risk of cardiovascular events, as this event data has not yet been presented. Since there do not seem to be any safety issues, there is no urgency to having patients taken off Zetia and replaced with either higher doses of statins, niacin or resins until the full clinical trial results are presented."