Statins for delaying the onset and progression of age-related macular degeneration

Gehlbach P, Li T, Hatef E

Published Online:

July 8, 2009

Age-related macular degeneration (AMD) is a progressive late onset disorder of the macula affecting central vision. Studies have shown that some of the factors that may lead to atherosclerosis and strokes are the same as those which may lead to AMD. Statins have proved very effective in preventing strokes, so it is possible that they are also protective for AMD. A number of observational studies have examined the relationship between AMD and the use of statins; however, the results have been contradictory.
This systematic review identified one completed and one ongoing randomized controlled trial. Of the completed trial, in which 30 patients received either 20 mg simvastatin or a placebo daily for a period of three months, the analyses did not show a statistically significant difference in visual acuity at completion of study treatment or 45 days after the completion of study treatment. Of the ongoing trial, the preliminary analyses after 12 months of treatment did not show a statistically significant difference between 40 mg simvastatin daily and placebo in visual acuity, drusen score or visual function. Due to the small size of the completed trial and the short duration of the treatment and follow-up period, no conclusion regarding the effects of statins on the onset or progression of AMD can be made at this time. We will update this review as data from the ongoing trial become available.

Abstract (click to read)

Background:

Age-related macular degeneration (AMD) is a progressive late onset disorder of the macula affecting central vision. Age-related macular degeneration is the leading cause of blindness in people over 65 years in industrialized countries (Congdon 2003). Recent epidemiologic, genetic and pathological evidence has shown AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD.

Objectives:

To examine the effectiveness of statins compared with other treatments, no treatment, or placebo in delaying the onset and/or progression of AMD.

Search strategy:

We searched CENTRAL in The Cochrane Library, MEDLINE, EMBASE and LILACS on 30 April 2009 and the WHO International Clinical Trials Registry Platform on 11 May 2009. We searched reference lists and the Science Citation Index. There were no language or date restrictions in the search for trials.

Selection criteria:

We included randomized controlled trials (RCTs) that compared statins with other treatments, no treatment, or placebo in participants who were either susceptible to or diagnosed as having early stages of AMD.

Data collection and analysis:

Two authors independently evaluated the search results against the selection criteria. Two Italian speaking colleagues extracted data. One author entered data. We did not perform a meta-analysis because only one completed RCT was identified.

Main results:

Two studies met the selection criteria. One trial reported insufficient details to assess the risk of bias; the other trial is ongoing.

Of the completed trial, the analyses of 30 participants did not show a statistically significant difference between the simvastatin and the placebo arm in visual acuity at three months of treatment (decimal visual acuity 0.21± 0.56 in simvastatin and 0.19± 0.40 in placebo arm) or 45 days after the completion of treatment (decimal visual acuity 0.20± 0.50 in simvastatin and 0.19± 0.48 in placebo arm). The lens and retina status were unchanged during and after the treatment period for both groups.

Of the ongoing trial, the preliminary analyses of 42 participants who completed 12 months follow-up did not show a statistically significant difference between the simvastatin and the placebo arm in visual acuity, drusen score or visual function (effect estimates and confidence intervals were not available). We contacted the investigators and will update the review as data become available.

Authors' conclusions:

Evidence from currently available RCTs was insufficient to conclude that statins have any role in preventing or delaying the onset or progression of AMD.

This record should be cited as:

Gehlbach P, Li T, Hatef E. Statins for age-related macular degeneration. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD006927. DOI: 10.1002/14651858.CD006927.pub2

Assessed as up to date:

April 30, 2009

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Primary Review Group:

Eyes and Vision Group

PEARLS - Practical Evidence About Real Life Situations (click to read)

Clinical question:

How effective are statins in delaying the onset and/or progression of age-related macular degeneration (AMD)?

Bottom line:

In the one completed trial, the analyses of 30 participants showed no statistically significant difference between the simvastatin and the placebo arm in visual acuity at 3 months of treatment or 45 days after the completion of treatment. The lens and retina status were unchanged during and after the treatment period for both groups. In the ongoing trial, the preliminary analyses of 42 participants who completed 12 months' follow-up did not show a statistically significant difference between the simvastatin and the placebo arm in visual acuity, drusen score or visual function (effect estimates and confidence intervals were not available).

Caveat:

There were only 2 small studies, one of which is still ongoing.

Context:

AMD is a progressive late onset disorder of the macula that affects central vision. Although AMD is the leading cause of blindness in people over 65 years in industrialised countries,¹ its pathogenesis is not clearly understood. Recent epidemiologic, genetic and pathological evidence has shown AMD shares a number of risk factors with atherosclerosis, leading to the hypothesis that statins may exert protective effects in AMD. 1. Congdon NG et al. JAMA 2003;290:2057-60

Cochrane Systematic Review:

Gehlbach P et al. Statins for age-related macular degeneration. Cochrane Reviews 2009, Issue 3. Article No. CD006927. DOI: 10.1002/14651858.CD006927.pub2. This review contains 2 studies involving 72 participants.

Authored by:

Brian R McAvoy

Cochrane Primary Health Care Field

Health topics:

Eyes & vision > Retinal degeneration > Macular degeneration

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Statins for delaying the onset and progression of age-related macular degeneration

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