ENHANCE Study Results

January 16, 2008

Cooper Clinic statement regarding results of recently reported ENHANCE trial

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 on Jan. 14, 2008.

The results of this study of 720 participants suggested no benefit from ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone in decreasing the progression of atherosclerosis in the carotid arteries. This has caused concern amongst many of our patients taking either Zetia or Vytorin, so the physicians at Cooper Clinic would like to provide the following information:

1. Patients should not discontinue their medicine if taking either Vytorin or Zetia.
   
   
2. This study was conducted on a specific group of people with a rare genetic form of elevated cholesterol, so extrapolating the results to the general population is difficult.
   
   
3. The end point used in this study was an imaging test (ultrasound of the carotid arteries), not clinical outcomes (heart attacks, strokes, deaths), so making statements on the clinical use of these medicines is not possible.
   
   
4. The American College of Cardiology has also released a statement recommending "major clinical decisions not be made on the basis of the ENHANCE study alone." (www.acc.org/enhance.htm).
   
   
5. We feel that Zetia and Vytorin remain viable and effective strategies for lowering LDL cholesterol in patients and that decisions as to which therapy is most appropriate should be made in consultation with your doctor. The ENHANCE trial, as it currently stands, does not effect our use of these medications.

Podcast
Dr. Tedd Mitchell, president and chief operating officer of Cooper Clinic, discusses the ENHANCE study results – Listen to the Podcast