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ENHANCE TRIAL |
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|---|---|
| Problem | Familial hypercholesterolemia |
| Format | Double-blinded multi-center RCT |
| Treatment | Ezetimibe (+simvastatin 80) |
| Control | Placebo (+simvastatin 80) |
| Population | 720 patients |
| Inclusion criteria | Men and women between the ages of 30 and 75 years were eligible to participate in the study if familial hypercholesterolemia had been diagnosed either by genotyping or by their having met the diagnostic criteria outlined by the World Health Organization. Patients were enrolled regardless of their previous treatment with lipid-lowering drugs. Untreated levels of LDL cholesterol had to be 210 mg per deciliter (5.43 mmol per liter) or more. Patients who were receiving lipid-lowering therapy and who had an LDL cholesterol level of less than 210 mg per deciliter at the time of screening were permitted to undergo randomization if their LDL cholesterol level was 210 mg per deciliter or more after the placebo run-in period. |
| Exclusion criteria | High-grade stenosis or occlusion of the carotid artery History of carotid endarterectomy or carotid stenting Homozygous familial hypercholesterolemia New York Heart Association class III or IV congestive heart failure Cardiac arrhythmia Angina pectoris Recent cardiovascular events. |
| Follow-up | 24 months |
| Primary endpoint | Change in mean carotid-artery intima–media thickness (Defined as the average of the means of the far-wall intima–media thickness of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries in the two study groups, assessed by ultrasound) |
| Secondary endpoint(s) | Proportion of patients with regression in the mean carotid-artery intima–media thickness from baseline Proportion of patients with new carotid-artery plaques of more than 1.3 mm Change from baseline in the mean maximal carotid-artery intima–media thickness Change from baseline in the average mean intima–media thickness of the carotid and common femoral arteries |
| Details | The study consisted of three periods: a screening phase, a single-blind placebo run-in period of 6 weeks, and a double-blind study period with a scheduled duration of 24 months. |
| Brief summary: | Ezetimibe added to simvastatin reduced LDL but not plaque size |
| PAPER: Simvastatin with or without ezetimibe in familial hypercholesterolemia | |
|---|---|
| Date | 3 Apr 2008 |
| Journal | N Engl J Med. 2008 Apr 3;358(14):1431-43. |
| Information | Ezetimibe Simva 80 vs. Simva 80 alone -NOT a clinical outcome trial -Aimed to assess reduction in intima–media thickness --Thought as a surrogate of vascular disease Showed: -Reduction in LDL (16.5%, P<0.01) & CRP -NO significant difference in atherosclerotic endpoint |