Merck/Schering-Plough Pharmaceuticals Provides Results of the ENHANCE Trial
Merck/Schering-Plough Pharmaceuticals announced the primary endpoint and other results of the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial.
ENHANCE was a surrogate endpoint trial conducted in 720 patients with Heterozygous Familial Hypercholesterolemia (HeFH). The primary endpoint was the mean change in the intima-media thickness (IMT) measured at three sites in the carotid arteries (the right and left common carotid, internal carotid and carotid bulb) between patients treated with ezetimibe/simvastatin 10/80 mg versus patients treated with simvastatin 80 mg alone over a two year period.
There was no statistically significant difference between treatment groups on the primary endpoint. The change from baseline in the mean carotid IMT was 0.0111 mm for the ezetimibe/simvastatin 10/80 mg group versus 0.0058 mm for the simvastatin 80 mg group (p =0.29). At baseline, the mean carotid IMT measurement for ezetimibe/simvastatin was 0.68 mm and for simvastatin 80 mg was 0.69 mm. There was also no statistically significant difference between the treatment groups for each of the components of the primary endpoint, including the common carotid artery. Key secondary imaging endpoints showed no statistical difference between treatment groups.
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Elastin
Stabilization is an Effective and Safe Treatment for
Abdominal Aortic Aneurysms (AAAs) in a Rat Model
Currently,
a pharmacologic treatment for AAAs does not exist. Present
treatment options include endovascular stents or open
surgery, but these procedures are not appropriate for all
patients and there are risks involved. One of the
characteristic features of AAAs is matrix metalloproteinase
(MMP) mediated loss of elastin. However, elastin can be
rendered resistant to enzymatic degradation when bound by
tannins. Jason C. Isenburg, PhD and Dan T. Simonescu, PhD et
al from the Department of Bioengineering at Clemson
University in Clemson, SC explored the effects of
polyphenolic tannins, specifically petagalloly glucose (PGG),
on AAA development. The results of their study, published in
the April 3, 2007 issue of Circulation, concluded
that acute localized periadventitial delivery of
noncytotoxic concentrations of PGG inhibits elastin
degradation, attenuates aneurysmal diameter expansion, and
hinders development of AAA in an established animal model.
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Treating Prehypertension with an Angiotensin-Receptor Blocker
Reduces the Development of Hypertension
Prehypertension is
considered a precursor of hypertension. The Trial of Preventing
Hypertension (TROPHY) in the United States investigated whether
two years of treatment with candesartan could reduce the
incidence of hypertension in prehypertensive patients. The trial
found that candesartan treatment reduced the incident
hypertension in the prehypertensive participants. These results
were published in the April 20, 2006 issue of The New England
Journal of Medicine.
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