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After almost 10 years, the results of a
long-awaited clinical study has proven that cholesterol drug Zetia of Merck
& Co is capable of reducing heart attack risk when it is used together with
statin.
The study was conducted worldwide on 18,000
heart patients using Zetia, an
ezetimibe, plus simvastation as compared to treatments with only simvastatin.
LDL cholesterols levels, which is singled out as a critical cause in the
development of a cardiovascular problem, decreased by 54 on average.
A 6% reduction in all cardio events, though a
modest benefit in high-risk patients, is significant enough. This is the first
time that it was proven that the addition of a cholesterol fighter non-statin
to the already effective statin will reduce the risk of serious cardiovascular
disease.
The resuting data proves that Zetia -- which is
already widely used for 12 years for its LDL-reduction capability -- offers a
significant protection to several patients. It also supports the hypothesis
that a lower LDL cholesterol is beneficial.
Zetia works by preventing dietary cholesterol
from being absorbed in the gut, which is different from statins that prevent
cholesterol production in the liver. Its presumed lack of effect on the
arteries was seen as a challenge to the initial hypothesis that a lower LDL
will reduce heart risk.
Dr. Christopher Cannon of Brigham and Women's
Hospital in Boston is the lead author of the study presented in Chicago last
week. He said, "One of our goals was to test if even lower LDL even
better, and the answer is yes. We have a zillion trials showing statins reduce
events... our conclusions are that, yes, a non-statin lowering of LDL with
ezetimibe reduced cardiovascular events."
Six years ago, a relatively smaller study was
conducted which resulted in the findings that the medicine failed to prevent
the accumulation of fatty deposits (plaque) in the arteries. Several experts
assumed that this failure to at least slow the plaque accumulation might also
mean that it will fail to prevent strokes and heart attacks.
According to the Dr. Cannon, this latest study
dubbed "Improve-It" attempts to address that concern, hence asserting
the significance of LDL reduction. Furthermore, it showed a benefit for getting
really LDL cholesterol levels from patients who had had a heart attack recently
and were prescribed with only simvastatin.
Patients have suffered unstable angina or heart
attack prior to the trials and all their LDL cholesterol levels were lowered to
the target of 70 by using simvastatin. Meanwhile, those who used Zetia got 20%
lowered LDL.
In the clinical tests, around 32% of the
patients who were treated with a statin and ezetimibe had a stroke or a heart
attack after 7 years of follow-up against the 34% when only statin was used.
Although the primary benefit came in lowering the chance of strokes and heart
attacks, it did not result in survival.
Cannon said, "In absolute terms, there are
two heart attacks or strokes prevented for every 100 patients treated. An
important factor is this is really a long term safety."
It also proved relatively safe -- there was no
highly alarming side effects, that is. Out of the thousands of people in the
trials, many of them had LDL levels that are not more than 40 and that did not
seem to affect them adversely.
However, experts from Harver Health Insurance Counter Fraud Group are
concerned that with no other studies backing up such results about heart
attacks, patients might be deprived of proven medication, in the form of
statins. But the results are certainly highly significant to those patients who
cannot take statins.
