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Title: Proof of concept, randomized, placebo-controlled study of the effect of simvastatin on the course of age-related macular degeneration
Authors: Guymer R.H.
Baird P.N.
Varsamidis M.
Busija L.
Dimitrov P.N.
Aung K.Z.
Makeyeva G.A.
Richardson A.J.
Lim L. 
Robman L.D.
Keywords: Aged
Aged, 80 and over
Apolipoprotein E2
Complement Factor H
Disease Progression
Double-Blind Method
Follow-Up Studies
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Intervention Studies
Macular Degeneration
Middle Aged
Polymorphism, Genetic
Risk Factors
Issue Date: 2013
Citation: Guymer R.H., Baird P.N., Varsamidis M., Busija L., Dimitrov P.N., Aung K.Z., Makeyeva G.A., Richardson A.J., Lim L., Robman L.D. (2013). Proof of concept, randomized, placebo-controlled study of the effect of simvastatin on the course of age-related macular degeneration. PLoS ONE 8 (12) : e83759. ScholarBank@NUS Repository.
Rights: Attribution 4.0 International
Abstract: Background: HMG Co-A reductase inhibitors are ubiquitous in our community yet their potential role in age-related macular degeneration (AMD) remains to be determined. Methodology/Principal Findings: Objectives: To evaluate the effect of simvastatin on AMD progression and the effect modification by polymorphism in apolipoprotein E (ApoE) and complement factor H (CFH ) genes. Design: A proof of concept double-masked randomized controlled study. Participants: 114 participants aged 53 to 91 years, with either bilateral intermediate AMD or unilateral non-advanced AMD (with advanced AMD in fellow eye), BCVA≥20/60 in at least one eye, and a normal lipid profile. Intervention: Simvastatin 40 mg/day or placebo, allocated 1:1. Main outcome measures: Progression of AMD either to advanced AMD or in severity of non-advanced AMD. Results. The cumulative AMD progression rates were 70% in the placebo and 54% in the simvastatin group. Intent to treat multivariable logistic regression analysis, adjusted for age, sex, smoking and baseline AMD severity, showed a significant 2-fold decrease in the risk of progression in the simvastatin group: OR 0.43 (0.18-0.99), p = 0.047. Post-hoc analysis stratified by baseline AMD severity showed no benefit from treatment in those who had advanced AMD in the fellow eye before enrolment: OR 0.97 (0.27-3.52), p = 0.96, after adjusting for age, sex and smoking. However, there was a significant reduction in the risk of progression in the bilateral intermediate AMD group compared to placebo [adjusted OR 0.23 (0.07-0.75), p = 0.015]. The most prominent effect was observed amongst those who had the CC (Y402H) at risk genotype of the CFH gene [OR 0.08 (0.02-0.45), p = 0.004]. No evidence of harm from simvastatin intervention was detected. Conclusion/Significance: Simvastatin may slow progression of non-advanced AMD, especially for those with the at risk CFH genotype CC ( Y402H). Further exploration of the potential use of statins for AMD, with emphasis on genetic subgroups, is warranted. Trial Registration: Australian New Zealand Clinical Trial Registry (ANZCTR) ACTRN1260500032065 © 2013 Guymer et al.
Source Title: PLoS ONE
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0083759
Rights: Attribution 4.0 International
Appears in Collections:Staff Publications

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