title: Statins and Fibrates for Diabetic Retinopathy: Protocol for a Systematic Review.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To assess the efficacy and safety of the drugs in the statin and/or fibrate groups for the prevention and treatment of DR.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  PROSPERO CRD42016029746.
authors.affiliation: Universidade Federal de Sao Paulo, Sao Paulo, Brazil.
authors.forename: Vania
authors.identifier: http://orcid.org/0000-0002-6243-1530
authors.initials: V
authors.lastname: Mozetic
authors.affiliation: Universidade Federal de Sao Paulo, Sao Paulo, Brazil.
authors.forename: Carolina Gomes
authors.identifier: http://orcid.org/0000-0001-7950-6511
authors.initials: CG
authors.lastname: Freitas
authors.affiliation: Universidade Federal de Sao Paulo, Sao Paulo, Brazil.
authors.forename: Rachel
authors.identifier: http://orcid.org/0000-0002-9522-1871
authors.initials: R
authors.lastname: Riera
keywords: diabetic retinopathy, hypolipidemic agents, hydroxymethylglutaryl-CoA reductase inhibitors, fibric acids, ETDRS, HMG-CoA reductase inhibitors