Abstract
Purpose: :
HMG Co-A Reductase inhibitors (statins) have actions apart from lowering cholesterol and have been found to reduce serum levels of high sensitivity C reactive protein (hs-CRP) in those with cardiovascular disease or high serum lipid levels. As elevated levels of CRP have been found to be an independent risk factor in the development of both cardiovascular disease and AMD, the aim of this study is to investigate the effect of simvastatin 40mg/day on cholesterol and hsCRP levels in subjects identified as being at high risk of AMD progression, but with normal lipid levels at baseline.
Methods: :
The ARMSS study (Age-Related Maculopathy Statin Study) is a 5-year, prospective randomised placebo-controlled trial on the effect of simvastatin in preventing the progression of high-risk early AMD. Assessment of AMD progression was based on fundus photographs and clinical findings. Cholesterol levels and hsCRP levels were taken in subjects at baseline and at 1, 3 and 5 years of follow up.
Results: :
Baseline and 12 month follow up hsCRP and cholesterol levels were available in 72 subjects (23 male, 49 female, mean age at baseline 74+/-7 years). Although not statistically significant, the median hsCRP level increased from 2.83mg/l to 3.00mg/L in the placebo group, but fell from 1.82 mg/l to 1.68 mg/l in the statin group. The proportion of subjects who had hsCRP levels above 3mg/l in the placebo group also increased from 36.8% of cases at baseline to 42.1% at follow up, whereas in those treated with simvastatin, a decrease from 35.3% to 23.5% was recorded (p=0.095).Mean Total Cholesterol levels in the statin group were found to fall significantly from 5.89mmol/L to 4.19mmol/L in comparison to a slight fall in the controls of 5.83mmol/L to 5.66mmol/L (p=0.001). A significant reduction in LDL-Cholesterol levels of 3.50mmol/L to 1.95 mmol/L was also seen in the statin group compared with 3.42mmol/L and 3.27 mmol/L in the controls (p=0.001). Triglyceride levels were also reduced in the statin group (1.23mmol/L to 0.88mmol/L) compared with relatively unchanged levels in controls (1.07mmol/L to 1.03mmol/L, p=0.089). HDL cholesterol levels in both groups remained unchanged.How these effects correlate with AMD progression is subject to further investigation in this study.
Conclusions: :
Simvastatin reduces both cholesterol and hsCRP levels in subjects with normal cholesterol levels and high risk early AMD.
Clinical Trial: :
www.anzctr.org.au ACTRN12605000320651
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • inflammation