Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial
a randomized, double-blind trial involving 1873 patients with mild-to moderate, asymptomatic aortic stenosis
patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily
primary outcomes was a composite of major cardiovascular events
patients 45-85 years at baseline; a median follow-up of 52.2 months
simvastatin and ezetimibe did not reduce the composite primary endpoint
cancer occurred more frequently in the simvastatin-ezetimibe group (105 vs. 70, P = 0.01)
an apparent excess of about one half in the incidence of any new cancer was observed during mean follow-up of approximately 4 years among the 944 patients randomly assigned to ezetimibe plus simvastatin as compared with the 929 randomly assigned to placebo
Notes:
following the results from SEAS an analysis of data from other ezetimibe trials was undertaken (2):
positive aspects of analysis
lack of cancer risk from analysis of 2 larger studies
SHARP
9264 patients (mean follow-up 2.7 years)
patients at least 40 years of age at baseline Simvastatin 20mg/ezetimibe versus placebo
IMPROVE-IT
11,353 patients (mean follow-up 1 year)
patients at least 50 years of age at baseline
simvastatin 40mg/ezetimibe versus simvastatin 40mg
no specific increase in a particular type of cancer in SEAS
the analysis suggests that:
data suggests a 'chance' finding - not a primary end point of any of the studies
data from two larger studies does not support findings from SEAS
however the data from the SHARP study and IMPROVE-IT study was over a lesser period of exposure to ezetimibe than in SEAS
need longer term data from SHARP and IMPROVE-IT to clarify the results further
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