The first study to investigate the efficacy of the cholesterol absorption inhibitor, ezetimibe, has shown no benefit of the drug in an imaging study in patients with familial hypercholesterolaemia (FH).
The ENHANCE study compared two years of treatment with ezetimibe/simvastatin 10/80 mg versus simvastatin 80 mg alone in 720 FH patients. The primary end point was the mean change in the intima-media thickness (IMT) measured at three sites in the carotid arteries. This showed no statistically significant difference between treatment groups, with the change from baseline being 0.0111 mm for the ezetimibe/simvastatin group versus 0.0058 mm for the simvastatin alone group (p=0.29).
Key secondary imaging end points, cardiac events and adverse events were also not different between the two groups. Ezetimibe was, however, associated with a greater reduction in low-density lipoprotein cholesterol (58% in the combination arm versus 41% in the simvastatin alone arm).
The American College of Cardiology (ACC) issued a statement after the ENHANCE results were released emphasising that 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.
The ACC recommends that major clinical decisions not be made on the basis of the ENHANCE study alone, and final conclusions should not be made until the ongoing clinical outcome trials are presented. It says ezetimibe remains a reasonable option for patients who are currently on a high-dose statin but have not reached their lipid goals and for patients who cannot tolerate statins or can only tolerate a low-dose statin.