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 resulting 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.
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Harver Health Insurance Counter Fraud Group was established in July 2001 through the joint action of several large insurers. The objective today remains as it was then, which is to prevent and detect fraud within health care. The Group initially convened to consider matters of common concern and to exchange information and specified potential frauds within a mutually-accepted terms of reference.
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