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ENHANCE: Effect of ezetimibe on atherosclerosis remains unknown

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CHICAGO — Although ezetimibe plus simvastatin combination therapy lowers LDL cholesterol, its effects on intima-media thickness are not significant in patients with familial hyperlipidemia, according to data from the ENHANCE trial presented during Sunday's sessions by John J.P. Kastelein, MD, PhD, professor of medicine at the University of Amsterdam.

In ENHANCE, a randomized, double-blind, 24-month trial, Kastelein and colleagues compared the change in carotid-artery intima–media thickness in patients aged 30 to 75 years with familial hyperlipidemia. Patients were randomly assigned to 80 mg simvastatin (Zocor, Merck; n=363) or 10 mg ezetimibe plus 80 mg simvastatin (Vytorin, Merck/Shering-Plough Pharmaceuticals; n=357) to determine the combination’s effect on the progression of atherosclerosis.

In the simvastatin-only group, the researchers reported a 0.0058 mm (±0.0037 mm) change in carotid-artery intima–media thickness, compared with 0.0111 mm (±0.0038 mm) in the combination therapy group (P=.29). LDL cholesterol levels at the completion of the study were 4.98 mmol/L (±1.56 mmol/L) in the simvastatin group and 3.65 mmol/L (±1.36 mmol/L) in the combination therapy group. The between-group difference was 16.5% (P<0.01).

The results of ENHANCE were published today in an online-first edition of the New England Journal of Medicine. – by Stacey L. Adams

For more information:

• Kastelein J, Akdim F, Stroes E, et al. Simvastatin with or without ezetimibe in familial hypercholesterolemia. American College of Cardiology 57^th Annual Scientific Session. March 29-April 1, 2008. Chicago.
• N Engl J Med. 2008;doi: 10.1056/NEJMoa0800742.

This is a negative trial that should change practice. Yes, change practice, especially given the way that we, in this country, have been prescribing ezetimibe.

For clinicians who may have employed this medication before exhausting options with statins, the strongest recommendation we can make on this panel is: turn back to statins, especially those with favorable outcomes data. [Statins] are remarkable drugs, we know they lower risks and we need to go back to what works; let’s stay with the evidence.

– Harlan M. Krumholz, MD

Professor of Medicine and Epidemiology and Public Health at Yale University