Can HMG Co–A Reductase Inhibitors ("Statins") Slow the Progression of AMD?

Abstract

Abstract: : Purpose:The relationship between AMD and the use of HMG CoA reductase inhibitors (cholesterol lowering drugs) or 'statins' has been examined in a number of clinical studies, with the results being contradictory. These studies have been retrospective, cross–sectional or longitudinal population based studies. Some studies have found an inverse association between statin use and AMD, with advanced AMD being less in subjects using statins.There is no randomized controlled trial to definitively address the question of statins and AMD. We are conducting a pilot, randomised, controlled trial "The Age–related Maculopathy Statins Study" (ARMSS), to determine if statins can slow the progression of early AMD to end–stage AMD. Methods: Subjects with high risk AMD (at least 5 drusen >125um in both eyes, or one eye with end–stage AMD and the other with signs of early AMD) are randomized to received either 40mg of Simvastatin (MSD) or placebo for 3 years. At baseline, then 6 monthly for 3 years they undergo an ophthalmic examination, retinal photography and visual function tests. Fundus photo–grading is performed to document progression or regression of AMD and visual function tests are analysed to detect improvements or deterioration in function. Results: To date 85 subjects have been enrolled, with 60 having completed 6 months, 42 completed 12 months, and 14 completed 18 month follow up. The 12 month data is presented here. 23 subjects are in the placebo group, with 5 being end–stage in their non–study eye. 19 subjects are receiving active drug with 10 having an end–stage lesion in their non–study eye. In the analysis of those whose vision improved > 3 letters, lost > 3 letters, or reached end–stage there was no significant difference between the 2 groups. The analysis of the drusen scoring to assess progression or regression of retinal features also showed no significant difference between the groups. In the visual function results,(rod, cone thresholds and adaptation) there were also no significant differences between the groups. Conclusions: At 12 months there is no significant differences in the two groups. There is a higher risk profile in the group receiving active treatment as there was double the number who were already end–stage in their non study eye and all 6 study eyes that did not register a rod cone break by 30 minutes, (worse retinal function),were in the treatment group. We will need to continue recruitment and analysis at later time points to gain further valuable information regarding statins in AMD.

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • lipids