�The data link between cholesterol-lowering drug ezetimibe (marketed as Vytorin) and cancer is still non clear, wrote the editors of the leading aesculapian
journal New England Journal of Medicine (NEJM). More time is needed to assess the drug, they said, and in the meantime patients and
doctors will take to live with the uncertainty.
The editorial appears in the online first 2nd September exit of NEJM, along with a report of the SEAS clinical trial of lipid-lowering therapy
which tried the combination of simvastatin and ezetimibe compared with placebo on the incidence of cardiovascular events in older hoi polloi with
aortic valve stenosis (abnormal narrowing of the marrow valve that lets blood into the aorta).
While the trial establish that the treatment did not halt aortic stenosis or show impact on cardiovascular events in general (apart from one or two
exceptions), it showed an unexpected result in adverse events, where there appeared to be a rise in cancer incidence and cancer deaths in the
treatment group compared to the placebo group.
This would make sense, since the way ezetimibe works is to reduce the absorption of cholesterol in the gut, which could also interfere with the
absorption of other substances that pretend cancer growth.
However, the SEAS researchers suggested that the higher incidence of cancer in the treatment group could be due to chance, just agreed further studies
should look into it. A group of epidemiologists from Oxford University did look into it by victimisation the SEAS data and supplementing it with information from deuce
other ongoing studies on ezetimibe, SHARP and IMPROVE-IT, which although had shorter follow ups than the four years in the SEAS trial, were
much larger and gave more than cancer information. They then examined the three sets of data to see if the imbalance in incident cancers and cancer deaths
from the SEAS trial was replicated in the other two trials.
The Oxford group's analysis failed to confirm the increment in incident cancer plant in the SEAS trial, but it did affirm the nonsignificant increase in
cancer deaths. Their study is as well reported in the 2nd September publication of NEJM.
The editors pointed out that it was authoritative to banker's bill that patch cancer mortality is an end point that 1 would require to be reliable, none of the trials
was designed to assess this as a primary consequence.
When the Oxford group combined the data on cancer deaths from the three trials (SEAS, SHARP, and IMPROVE-IT), they found an increase in danger
of malignant neoplastic disease death in the combined ezetimibe groups (134 versus 92 deaths in controls, showing a risk ratio of 1.45 and an uncorrected P=0.007).
But the Oxford group aforesaid it believed this finding was strictly due to chance and could not be a real rise in crab death peril because if that were the
case then in that respect should experience been a corresponding rise in crab incidence.
Again, the editors cautioned that because the test of statistical import, P, comes from an analysis that combines data from studies with different
objectives, it should be interpreted carefully. They wrote that although the Oxford researchers crataegus oxycantha ultimately be proved correct, patients and doctors
should be cautious because it is not clear whether the increased risk of death is due to chance or not. Because of the way it affects preoccupancy of
chemicals in the gut, ezetimibe may well affect the balance of cancer neutering substances too.
"The fact that the combined data from all trey trials showed an increase in cancer mortality with ezetimibe should not be assumed to be a chance
finding until farther data are in," wrote the editors.
The editors aforesaid the SHARP and IMPROVE-IT trials must go on and on that point should be careful follow up of the patients. These and other trials yielding
information on ezetimibe treatments should be analyzed for cancer-related results, they wrote, and mentioned that the US Food and Drug Administration
(FDA) had plans to carry out its possess analysis.
"Ezetimibe and Cancer -- An Uncertain Association."
Drazen, Jeffrey M., D'Agostino, Ralph B., Ware, James H., Morrissey, Stephen, Curfman, Gregory D.
N Engl J Med 2008 0: NEJMe0807200; published online number one 2 September 2008.
Click here for the full Editorial.
Sources: NEJM.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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Monday, 8 September 2008
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