Study authors concluded there is insufficient evidence supporting the role of statins in preventing or delaying the onset or progression of age-related macular degeneration (AMD), according to a study published in the Cochrane Database of Systematic Reviews.
Recent data demonstrated that AMD shares several risk factors with atherosclerosis, pointing to the hypothesis that statins may exert protective effects in AMD. The review was conducted to examine the efficacy of statins vs. other treatments, no treatment, or placebo in slowing the onset and progression of AMD. Randomized controlled trials and quasi-randomized trials comparing statins with other treatments, no treatment, or placebo in patients with early-stage AMD were included for the review.
Two randomized controlled studies (n=144) met the inclusion criteria. Both studies compared simvastatin vs. placebo in patients older than 50 or 60 years with high risk of developing AMD. The quality of evidence was low due to limitations in the study designs and insufficient outcome reporting.
The bigger trial (n=114) evaluated the higher dose (40mg daily) of simvastatin for 3 years. Although study participants and personnel were adequately masked, data were missing for 30% of patients at the 3-year follow-up. The smaller trial (n=30) evaluated the lower dose (20mg daily) of simvastatin for 3 months. This study reported insufficient details to determine the risk of bias.
Both trials did not report data on change in visual acuity. Data from the smaller trial did not demonstrate a statistically significant difference between the simvastatin and placebo groups in visual acuity values at 3 months of treatment (decimal visual acuity 0.21 vs. 0.19, respectively) or after 45 days of post-treatment (decimal visual acuity 0.20 vs. 0.19, respectively).
Preliminary analyses of 42 patients that completed 12-month follow-up from the larger trial did not show a statistically significant difference between simvastatin and placebo groups for visual acuity, drusen score, or visual function. Moreover, full data for these outcome measures at 3-year follow-up were not reported. Regarding adverse events, one trial did not report adverse outcomes, and the second trial reported no difference between the groups.
Overall, low-quality evidence showed the effect of simvastatin in slowing progression of AMD vs. placebo to be uncertain (odds ratio 0.51, 95% CI: 0.23–1.09).
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