Healthy Clinical Trial
Official title:
Effect of Simvastatin Withdrawal on Ocular Endothelial Function
Statins are drugs representing the most commonly prescribed medication for the treatment of
hypercholesterolemia. In a recently published study, discontinuation of statin therapy in
patients after acute myocardial infarction was associated with a higher all-cause mortality
(hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence
suggests that statins also have vasoactive properties by up-regulating endothelial nitric
oxide synthase (eNOS) with positive effects on endothelial function. Experiments with
flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on
endothelial function but also revealed that withdrawal of statin treatment transiently
worsens endothelial function, independently of serum cholesterol levels.
Consequently, this placebo controlled Phase IV crossover study wants to assess changes of
endothelial function in terms of flicker induced vasodilatation before and during statin
therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be
treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced vasodilatation
and retinal oxygen saturation will be measured with the Dynamic Vessel Analyzer system by
Imedos at baseline, in the 4th week of simvastatin or placebo intake as well as 3, 7 and 14
days after the end of intake.
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