Could you please comment on why the FDA has not issued an official advisory, but media is hyping and misleading the public regarding results from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia). Merck and Schering-Plough submitted this for presentation as an pre-publication abstract at the American College of Cardiology meeting in March 2008.
Can you confirm these that I could dig up:
* No difference between patients treated with ezetimibe/simvastatin 10/80 mg (Vytorin) versus patients treated with simvastatin 80 mg alone, over a two year period, for the primary endpoint of the mean change in intima-media thickness (IMT) measured at three sites in the carotid arteries. Carotid ultrasound studies are seen as reliable surrogate markers and predictive of future cardiac events. There was a NON-statistically significant difference in wall thickness (p=0.29).
* The Heterozygous Familial Hypercholesterolemia (HFH) population studied had baseline LDL measurements > 300 mg/dL. These patients make up 0.2% of the general population and are NOT representative of the typical patient receiving medication for hyperlipidemia.
* Since conclusive evidence of ezetimibe's true effect is not available until studies on the general population with more power are published, maximizing statin dosing whenever possible is warranted for many patients with hypercholesterolemia. Niacin or colesevelam (Welchol) are alternatives to consider for statin intolerant patients.
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