Ezetimibe doesn't ENHANCE statins
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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Hannah,
Data that I've managed to find for cholesterol reduction show that atorvastatin 40mg is marginally more effective than simvastatin 80mg (LDL-C reduction of 51% versus 47%). There is also the issue of tolerability with increase doses.
The big debate with statins at the moments is what to use second - nobody argues with simvastatin 40mg first line but second place could go to dose titration, atorvastatin, rosuvastatin or adding ezetimibe.
I'm tending towards a well tolerated and evidence based selection by choosing atorvastatin but there is little to choose between using atorvastatin or a higher dose of simvastatin as second choice.
Comment by Matthew Robinson — February 14, 2008 #
Why not go for simva 80mg second line? How does that compare with atorva 40mg?
Note that 2x40mg simva would be more cost effective.
Comment by Hannah — February 13, 2008 #
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Pingback by NPCi blog » Blog Archive » Ezetimibeâ–¼ doesn’t ENHANCE statins — February 11, 2008 #
Will
After trying simvastatin 40mg the next step would be atorvastatin 40mg based upon the expected additional lipid lowering (lipid reducing effects are averaged in some SPCs).
The recent NICE guidance was produced without the results of this study. One must ponder if the NICE guidance would have been quite so positive in light of these recent results. However, the guidance still applies well to current practice; titrate the current statin and consider changing the statin before adding in ezetimibe.
Comment by Matthew Robinson — February 8, 2008 #
What dose of Atorvastatin would you advocate and why?
Also with the recent positive NICE guidance would you not think Ezetimibe addition is still a good opiton despite disappointing results in a surrogate study?
Comment by Will — February 7, 2008 #