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Mary Varsamidis, Liubov D. Robman, Lucy Busija, Peter N. Dimitrov, Khin Zaw Aung, Galina A. Makeyeva, Paul N. Baird, Robyn H. Guymer; HMG Co-A Reductase Inhibitor Delays Progression Of Early AMD. The Age-Related Maculopathy Statin Study(ARMSS). Invest. Ophthalmol. Vis. Sci. 2011;52(14):1235.
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Currently there is no specific intervention to slow the progression of early age-related macular degeneration ( AMD) . Some evidence suggests that HMG Co-A reductase inhibitors may be beneficial but no randomized clinical trial ( RCT) has reported on their use in AMD. Our aim was to determine whether the HMG Co-A reductase inhibitor Simvastatin slows the progression of early AMD.
ARMSS is a 3-year randomized placebo-controlled double-masked trial of Simvastatin 40mg/day in participants with either bilateral high risk early AMD, or in participants where one eye had reached end stage AMD and the other had early AMD. 114 participants with high risk of AMD progression were randomized to receive either a placebo or Simvastatin. Progression was determined on digital macular images and validated through clinical angiographic examination when needed. Primary Outcome was "progression to late AMD or ≥ 15 letters visual acuity loss". Secondary Outcome was "any progression of AMD", which included those who progressed by primary outcome, as well as those whose AMD status worsened within early AMD. We conducted intention to treat, on protocol and cross-over analyses, for the whole sample and in stratification by the initial risk of progression.
A total of 104 participants from the 114 randomised contributed to follow-up, with 2 being excluded after randomisation. The mean age was 74.3 (± 6.6) years in placebo and 74.7 (± 7.2) years in the Simvastatin group. Late AMD was present in one eye at baseline in 32% of the placebo group and in 53% of the Simvastatin group. In intention to treat logistic regression analysis, adjusted for age, gender and smoking, there was a trend towards significant association between Simvastatin intake and slowing "any progression of AMD" for the total sample ( OR: 0.43, 95% CI: 0.17- 1.06, p= 0.07) . In the cases with bilateral early AMD only, "any progression of AMD" was significantlly lower in the Simvastatin group compared to the placebo group: ( OR: 0.25, 95% CI: 0.07- 0.88, p= 0.03) . We found no significant difference between groups in "progression to late AMD or ≥ 15 letters in visual acuity loss" and for those who had previously developed late AMD in one eye.
HMG Co-A reductase inhibitor Simvastatin delayed progression of AMD in cases with bilateral early AMD.
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