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      Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review


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          Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus, and more than 75% of patients who have had diabetes for more than 20 years will have some degree of DR. This disease is highly destructive to self-esteem and puts a high burden on public health and pension systems due to the effects that it has on people of working age. The current mainstay of treatment is laser photocoagulation, which causes impairment of vision and discomfort to patients. Thus, finding a systemic drug that could act on all microcirculation and prevent direct manipulation of the eyes would be highly desirable.


          To assess the efficacy and safety of the drugs in the statin and/or fibrate groups for the prevention and treatment of DR.


          In this systematic review, we will select randomized controlled trials of fibrates or statins used for the treatment or prevention of DR. Our search strategy will include free text terms and controlled vocabulary (eg, MeSH, Emtree) for, “diabetic retinopathy”, “statins”, “fibrates”, “hypolipidemic agents”, and for drugs from both groups. Databases that will be used include Medical Literature Analysis and Retrieval System/PubMed, Embase, Cochrane Central Register of Controlled Trials, Latin American and Caribbean Center on Health Sciences Information, Clinicaltrials.gov, World Health Organization International Clinical Trials Registry Platform, and OpenGrey, and we will not have language or date limits. Two review authors will independently select eligible studies and assess the risk of bias using the Cochrane Collaboration’s tool. We will report structured summaries of the included studies and, if possible, conduct meta-analyses.


          This is a protocol for a systematic review, therefore results are not available. We registered a short version of this protocol before progressing in the review and we are currently in the process of selecting the studies for inclusion.


          Intensive glucose control and lowering blood pressure and lipids are mechanisms that protect macrocirculation in diabetic patients. Both macrovascular and microvascular events in diabetic patients appear to have a common pathway, starting with endothelial injury. Thus, prevention and treatment of microvascular events may benefit from the same interventions. In the review for which we have written this protocol, we will assess whether the use of lipid-lowering oral drugs of the statin and/or fibrate groups may prevent and/or retard progression of DR, with the added benefit of preserving visual acuity.

          Trial Registration

          PROSPERO CRD42016029746

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          Most cited references28

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          Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial.

          Laser treatment for diabetic retinopathy is often associated with visual field reduction and other ocular side-effects. Our aim was to assess whether long-term lipid-lowering therapy with fenofibrate could reduce the progression of retinopathy and the need for laser treatment in patients with type 2 diabetes mellitus. The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a multinational randomised trial of 9795 patients aged 50-75 years with type 2 diabetes mellitus. Eligible patients were randomly assigned to receive fenofibrate 200 mg/day (n=4895) or matching placebo (n=4900). At each clinic visit, information concerning laser treatment for diabetic retinopathy-a prespecified tertiary endpoint of the main study-was gathered. Adjudication by ophthalmologists masked to treatment allocation defined instances of laser treatment for macular oedema, proliferative retinopathy, or other eye conditions. In a substudy of 1012 patients, standardised retinal photography was done and photographs graded with Early Treatment Diabetic Retinopathy Study (ETDRS) criteria to determine the cumulative incidence of diabetic retinopathy and its component lesions. Analyses were by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN64783481. Laser treatment was needed more frequently in participants with poorer glycaemic or blood pressure control than in those with good control of these factors, and in those with a greater burden of clinical microvascular disease, but the need for such treatment was not affected by plasma lipid concentrations. The requirement for first laser treatment for all retinopathy was significantly lower in the fenofibrate group than in the placebo group (164 [3.4%] patients on fenofibrate vs 238 [4.9%] on placebo; hazard ratio [HR] 0.69, 95% CI 0.56-0.84; p=0.0002; absolute risk reduction 1.5% [0.7-2.3]). In the ophthalmology substudy, the primary endpoint of 2-step progression of retinopathy grade did not differ significantly between the two groups overall (46 [9.6%] patients on fenofibrate vs 57 [12.3%] on placebo; p=0.19) or in the subset of patients without pre-existing retinopathy (43 [11.4%] vs 43 [11.7%]; p=0.87). By contrast, in patients with pre-existing retinopathy, significantly fewer patients on fenofibrate had a 2-step progression than did those on placebo (three [3.1%] patients vs 14 [14.6%]; p=0.004). An exploratory composite endpoint of 2-step progression of retinopathy grade, macular oedema, or laser treatments was significantly lower in the fenofibrate group than in the placebo group (HR 0.66, 95% CI 0.47-0.94; p=0.022). Treatment with fenofibrate in individuals with type 2 diabetes mellitus reduces the need for laser treatment for diabetic retinopathy, although the mechanism of this effect does not seem to be related to plasma concentrations of lipids.
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            Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7.

            The Early Treatment Diabetic Retinopathy Study (ETDRS), a multicenter collaborative clinical trial supported by the National Eye Institute, was designed to assess whether argon laser photocoagulation or aspirin treatment can reduce the risk of visual loss or slow the progression of diabetic retinopathy in patients with mild-to-severe nonproliferative or early proliferative diabetic retinopathy. The 3711 patients enrolled in the ETDRS were assigned randomly to either aspirin (650 mg per day) or placebo. One eye of each patient was assigned randomly to early argon laser photocoagulation and the other to deferral of photocoagulation. Both eyes were to be examined at least every 4 months and photocoagulation was to be initiated in eyes assigned to deferral as soon as high-risk proliferative retinopathy was detected. Examination of a large number of baseline ocular and patient characteristics indicated that there were no important differences between randomized treatment groups at baseline.
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              Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus.

              Clinical guidelines differ regarding their recommended blood glucose targets for patients with type 1 diabetes and recent studies on patients with type 2 diabetes suggest that aiming at very low targets can increase the risk of mortality.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                February 2017
                22 February 2017
                : 6
                : 2
                : e30
                [1] 1Universidade Federal de Sao Paulo Sao PauloBrazil
                Author notes
                Corresponding Author: Carolina Gomes Freitas crlngomesfreitas@ 123456gmail.com
                Author information
                ©Vania Mozetic, Carolina Gomes Freitas, Rachel Riera. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 14 September 2016
                : 3 December 2016
                : 15 January 2017
                : 21 January 2017

                diabetic retinopathy, hypolipidemic agents, hydroxymethylglutaryl-coa reductase inhibitors, fibric acids, etdrs, hmg-coa reductase inhibitors


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