HEALTH & MEDICINE :: JUNE/JULY 2008
Your ENHANCE Trial Questions, Answered
Many patients, nurses and physicians have questions regarding the use of Vytorin (the combination of Zocor [simvastatin] and Zetia [ezetimibe] in the treatment of dyslipidemia and atherosclerotic disease in light of the results of the ENHANCE trial. I will address what I see as the highlights of the study.
First, I don’t think any of the findings in the study warrant stopping Vytorin in any patient groups as long as the medication is achieving the LDL (bad) cholesterol lowering goal. The combination found in Vytorin should be the second line therapy if the LDL goal cannot be achieved, free of side effects, with statin drugs in combination with diet and exercise. Do not stop Vytorin unless your doctor knows and approves.
Second, the trial studied a group of patients not commonly seen in our practice in that the average cholesterols levels were well over 300 and they had been pretreated with statin drugs for two years prior to the trial. Most of our patients have cholesterols between 175 and 250. The two years of pretreatment may have achieved all the benefits that could and would be seen thus possibly explaining the lack of difference when comparing Vytorin and Zocor in these patients.
Third, the ENHANCE trial was small, 720 patients, and studied only the plaque (cholesterol build up) thickness in the carotid arteries and found no difference between the drugs. The trial was not large enough nor did it study the effect of the drugs of heart attack or stroke, the question that we really want answered. Also the study did not address the heart at all.
Fourth, ENHANCE did show a huge advantage for Vytorin over Zocor in lowering LDL cholesterol, 58 % reduction for Vytorin vs 42% for Zocor. Vytorin was also superior to Zocor in reducing Cardiac C-reactive protein (statistically significant) which in addition to LDL is an important predictor of the future risk of stroke and heart attack. LDL and reactive protein are the important measures that we currently use to guide our therapy. We and many large lipid clinics throughout the world know that ezetimibe frequently has to be added to a statin to achieve desired goals of therapy.
Fifth, Vytorin contains a simvastatin which we know is effective in lowering the risk of heart attack and stroke.
Sixth, the IMPROVE trial is ongoing and is studying Vytorin 10/40 vs Zocor 40 mg in patients with known coronary artery disease. It started in 2005 and is projected to end in 2011. It has already enrolled 11,000 patients with a projected 18,000 patients. This trial is large enough and designed to answer the questions we want answered: does the addition of ezetimibe to a statin decrease the risk of heart attack and stroke? Thus far the trial has passed its safety monitoring points telling us that the combination is not harmful to patients.
Seventh and lastly, the focus here has been on LDL cholesterol. Do not forget that there is twice as much benefit to raising HDL (good cholesterol) in prevention heart attack and stroke as there is with lowering LDL. The best way to raise HDL is to exercise 30 minutes every day and eat healthy.
We will keep you up to date on the IMPROVE-IT trial.
Cardiology Physicians, P.A.
Abby Medical Center
One Centurian Drive
Suite 200
Newark, DE 19713
302.366.8600
1401 Foulk Road
Suite 201
Foulkstone Plaza Wilmington, DE
302.478.5055
www.cardiocppa.com
GILBERT A. LEIDIG JR., M.D., F.A.C.C.
Dr. Leidig joined Cardiology Physicians in June of 1996. Dr. Leidig obtained a Bachelor of Science degree, Summa Cum Laude, from Loyola College in Baltimore, Maryland. He then attended the University of Pennsyl-vania School of Medicine. His post-graduate training in Internal Medicine came during a residency at the Walter Reed Army Medical Center in Washington, D.C. Dr. Leidig was an attending physician at Keller Army Hospital at the United States Military Academy in West Point, New York. He then did a cardiovascular fellowship at Beth Israel Hospital, Harvard Medical School, in Boston, Massachusetts. Dr. Leidig served as Chief of Cardiology at Womack Army Medical Center in Fort Bragg, North Carolina. He was a consulting associate and interventional attending at the catheterization laboratories at the Duke University Medical Center. His recognitions include membership in A.O.A., and the Best Doctors in Delaware. He is board certified in Internal Medicine, Cardiovascular Disease and Interventional Cardiology.
Dr. Leidig has a strong commitment to consultative and clinical cardiology. He has areas of interest including echocardiography, transesophageal echocardiography, and stress echocardiography. Dr. Leidig has expertise in diagnostic catheterization as well as coronary stent placement and angioplasty. He also has expertise in peripheral vascular disease and stent placement and angioplasty for the treatment of peripheral vascular disease.
Dr. Leidig and his wife Meaghen were married in 1985 and are the proud parents of Andrew, Patrick, Farrell and Molly. Our family enjoys gardening, running, swimming, birding and hiking as well as reading, trivia, stamp collecting and current events. Dr. Leidig is on the Pastoral Council at St. Mary of the Assumption Church in Hockessin and on the Salesianum School Board of Trustees.
