The results (login required) of the ENHANCE Study have found no significant difference between ezetimibe and simvastatin compared to simvastatin alone in patients with heterozygous familial hypercholesterolemia.
The results of this study were due to be presented later this year at a meeting of the American College of Cardiology but many of the results are already available in an attempt to "end speculation about the results of the study" according to the manufacturers.
The study recruited 720 patients with heterozygous familial hypercholesterolemia and randomised them to treatment with ezetimibe and simvastatin or simvastatin alone for a period of 2 years. The primary end point was the mean change in the intima media thickness as measured at three sites in the carotid arteries.
There was no statistical difference in the primary outcome, the components of the primary outcome or the secondary imaging end points. There were also no differences in cardiovascular event outcomes although the trial was not powered to assess these outcomes. Additional long-term cardiovascular outcome studies are on going but are not due for completion until 2011.
Action: Clinicians should be aware of this negative study. Current recommendations still apply, simvastatin 40mg remains first line and monotherapy with atorvastatin remains a suitable second line in patients who fail to reach the national cholesterol targets of 5mmol/L for total cholesterol or 3mmol/L for low-density lipoprotein (LDL-C).
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