| Abstract
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Background:
In the recently reported Simvastatin and Ezetimibe in Aortic Stenosis
(SEAS) trial, the combination of ezetimibe/simvastatin (E/S) was associated
with a significantly increased risk of cancer compared to placebo, causing
widespread public concern.
Objective: We examined the rates of cancer adverse event reports filed
with the US Food and Drug Administration (FDA) of patients on ezetimibe
or E/S, and compared these to reports with other potent cholesterol-lowering
drugs.
Methods: We tabulated all adverse event reports listing “cancer”
or “malignancy” filed with the FDA (July 2004 to March 2008)
of patients taking ezetimibe or E/S, and compared those to reports of
patients taking simvastatin, atorvastatin, or rosuvastatin. We calculated
rates for such reports per million prescriptions. A secondary analysis
examined cancer reports as a proportion of all reported adverse events
for each medication.
Results: Prescriptions for all drugs totaled 559 million (approximately
52 and 55 million prescriptions of ezetimibe and E/S, respectively), and
cancer adverse event reports totaled 2334. There were 2.9 and 1.3 cancer-associated
adverse event reports per million ezetimibe or E/S prescriptions, respectively,
compared to a range of 3.1 to 5.1 per million prescriptions for the other
drugs. Findings were similar when only reports listing the drug as “suspect”
were considered. The proportions of reports listing cancer relative to
all adverse event reports were 2.0% and 1.9% for ezetimibe and E/S, respectively,
compared to a range of 1.3% to 3.9% for the other drugs.
Conclusions: This large-scale post-marketing analysis of reported adverse
events does not support that ezetimibe or E/S increase the risk of cancer.
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