Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial
Last reviewed 01/2018
- 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
- positive aspects of analysis
Reference: