ENHANCE trial update: no beneficial effects on CA IMT from ezetimibe
The much-awaited results of the “Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression” (ENHANCE) trial are finally out – and they are a huge disappointment.
ENHANCE is an international 2-year, randomized, double-blind, controlled trial which compared the combination of ezetimibe and simvastatin to simvastatin monotherapy.
Simvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor routinely used in the management of atherosclerosis. The newcomer ezetimibe is a specific cholesterol absorption inhibitor and the 2 drugs supposedly act as complementary agents that can have beneficial effects on the carotid artery intima-media thickness (CA IMT) of atherosclerosis patients. The trial was conducted in 720 patients with heterozygous familial hypercholesterolemia. The primary end point was mean change in the IMT measured at 3 different sites in the carotid arteries [1].
The trial results showed no significant difference in the mean IMT change between patients treated with ezetimibe/simvastatin 10/80 mg vs patients treated with simvastatin 80 mg alone. There was also no significant difference in treatment-related adverse events in both treatment groups. However, ezetimibe was associated with a larger reduction in LDL cholesterol [2].
References:
1. Kastelein et al., 2005. Comparison of ezetimibe plus simvastatin versus simvastatin monotherapy on atherosclerosis progression in familial hypercholesterolemia Design and rationale of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial. American Heart Journal 149 (2): 234-239.
2. Hughes, S. 2008. ENHANCE results yield disappointment for ezetimibe. Heartwire 14 Jan 2008.
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One Comment
- PharMed News » Blog Archive » How Genetic Variation is Affecting Drug Development replied:
[…] Ezetimibe Ezetimibe is one of 2 combination drugs tested by the controversial ENHANCE trial. The study participants have heterozygous familial hypercholesterolemia, a genetic disorder that characterized by cholesterol deposition and high plasma concentrations of low-density lipoprotein cholesterol [5]. Unfortunately, the trial results did not show any benefit from ezetimibe. However, drug testing on genetically distinct populations is becoming a common practice in drug development. […]
March 9th, 2008 at 3:15 pm. Permalink.