NLA Statement on ENHANCE Study Findings: Premature Judgment Unwarranted
January 16, 2008
The limitations of the ENHANCE study, in terms of its design and the patients studied, are such that physicians should not alter their prescribing policies at this time. Current discussion regarding the ENHANCE Study is not based upon published work subject to peer review and thus cannot yet be evaluated by the medical community.
The ENHANCE trial was not powered to examine differences in clinical outcomes. The limitations in question include the patient population studied, which were patients who had familial hypercholesterolemia with an average baseline LDL-C of 319 mg/dL. The statin-ezetimibe combination reduced LDL-C more than did the statin alone. However, there were no statistically significant differences in the primary endpoint, which was carotid intimal-media thickness, as measured by ultrasound. The combination therapy (Vytorin) resulted in a greater reduction of LDL-C (17 percent) compared to simvastatin alone. Further, the therapy examined does not present safety concerns as there were no differences in adverse events between the two treatment groups.
Given that other studies are currently in progress to examine cardiovascular endpoints, generalization and extrapolation of ENHANCE results to different populations with regard to clinical outcomes is premature.
The National Cholesterol Education Program (NCEP) guidelines suggest patient goals but do not specify which drugs should be used to attain them. That matter is left to the judgment of the physician, whose primary objective is to help patients reach their treatment targets.
The NLA re-emphasizes the importance of following NCEP guidelines and ezetimibe and its combination form remain reasonable options that can be safely prescribed when appropriate. Until the ENHANCE Study is formally published and presented to the medical community, there is no basis on which physicians can make an informed decision and to do so now would be an unwarranted rush to judgment.
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