The “EFFECTS
Trial”
A Multicenter, Randomized, Double-Blind Placebo Controlled Study of
the Effect of Ezetimibe plus Simvastatin Compared to Simvastatin Alone
on Flow Mediated Brachial Artery Vasoactivity in Subjects with Primary
Hypercholesterolemia.
High cholesterol is a common condition that leads to strokes
and heart attacks. People who have high cholesterol are usually
treated with a low cholesterol diet, regular exercise, and one
or more medicines that lower cholesterol. Some of these cholesterol
medicines are also able to improve the way blood vessels in the
body work, making them even more helpful in preventing heart attacks
and strokes.
This study, called the Effects trial, looks at the way two cholesterol
medicines, simvastatin and ezetimibe, affect the way blood
vessels in the body work. Simvastatin and ezetimibe are prescription
medicines
that are used in people with high cholesterol when diet and
exercise can’t lower their cholesterol levels enough. Medicines
that can make the blood vessels work better and lower cholesterol
at
the same time are more likely to be helpful than medicines
that only lower cholesterol alone.
The Effects trial is being done at 25 centers around the world,
with 320 people in the study. People who join this study
will have high cholesterol that needs to be treated with medicines.
They will
take either simvastatin, simvastatin with ezetimibe, ezetimibe
by itself, or a placebo (sugar) pill every day for 12 weeks. Everyone
receives several blood tests as well as an ultrasound, or
sound
wave, test of an artery in the arm at the beginning and end
of the study. Afterwards, we will look to see if people who were given
the cholesterol medicines did better than those who didn’t.
We will also see if those people who got both medicines together
did better than those who only got one.