�The link between cholesterol-lowering drug ezetimibe (marketed as Vytorin) and cancer is still not clear, wrote the editors of the leading medical
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 suffer to live with the uncertainty.
The editorial appears in the online first second September topic of NEJM, along with a report of the SEAS clinical trial of lipid-lowering therapy
which tested the combination of zocor and ezetimibe compared with placebo on the incidence of cardiovascular events in older the great unwashed with
aortic valve stenosis (abnormal narrowing of the gist valve that lets ancestry into the aorta).
While the trial establish that the treatment did not halt aortic stricture or demo impact on cardiovascular events in general (apart from one or two
exceptions), it showed an unexpected result in adverse events, where in that respect appeared to be a rise in cancer relative incidence and cancer deaths in the
discussion group compared to the placebo group.
This would make sense, since the way ezetimibe kit and caboodle is to reduce the absorption of cholesterol in the gut, which could also step in with the
absorption of other substances that affect cancer growth.
However, the SEAS researchers suggested that the higher incidence of malignant neoplastic disease in the treatment group could be due to chance, merely agreed further studies
should look into it. A group of epidemiologists from Oxford University did look into it by using the SEAS data and supplementing it with information from deuce
other on-going 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 cancer data. 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 step-up in incident cancer constitute in the SEAS test, but it did confirm the nonsignificant increase in
cancer deaths. Their sketch is also reported in the 2nd September issue of NEJM.
The editors pointed prohibited that it was crucial to note that piece cancer mortality is an end point that one would look to be reliable, none of the trials
was designed to assess this as a primary final result.
When the Oxford grouping combined the data on cancer deaths from the three trials (SEAS, SHARP, and IMPROVE-IT), they found an step-up in jeopardy
of cancer the Crab 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 non be a real climb in cancer death risk because if that were the
example then there should have been a corresponding go up in malignant neoplastic disease incidence.
Again, the editors cautioned that because the test of statistical significance, P, comes from an analysis that combines information from studies with different
objectives, it should be interpreted carefully. They wrote that although the Oxford researchers may ultimately be proved right, 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 assimilation of
chemicals in the gut, ezetimibe may well affect the balance of cancer fixing substances too.
"The fact that the combined data from all ternion trials showed an increment in crab mortality with ezetimibe should not be assumed to be a chance
finding until further data are in," wrote the editors.
The editors aforementioned the SHARP and IMPROVE-IT trials must go on and there should be careful espouse 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 own 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 low 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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