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The ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial results were released by Merck and Schering-Plough Pharmaceuticals on January 14, 2008. Media reports indicate that the results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone in terms of changes in carotid artery thickness. The study involved 720 patients with very high levels of cholesterol from an inherited form of heart disease. The study was designed to prove that Vytorin could slow the growth of plaque in carotid arteries supplying the brain more than simvastatin alone.
According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. The difference in the changes in carotid artery thickening was 0.006 in the simvastatin group and 0.011 mm in the Vytorin group. Three large trials comparing Vytorin to Simvastatin will be published within the next 3 years.
There is no reason for patients to panic.
Concerned patients using these drugs should talk to their health care professional. This is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering therapy is preferred. The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone.
Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Final conclusions should not be made until the clinical outcome trials are presented. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their lipid goals. The ACC also notes that Zetia remains a reasonable option for patients who cannot tolerate statins or can only tolerate a low-dose statin.
Reports also indicate that the ENHANCE trial has been submitted as an abstract to be presented at the upcoming American College of Cardiology Scientific Session in March, 2008. The late-breaking clinical trial selections by the meeting co-chairs are scheduled to occur in late January.
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About the American College of Cardiology:
The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care.