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Association of Statin Therapy With Prevention of Vision-Threatening Diabetic Retinopathy.

ABSTRACT: Importance:Diabetic retinopathy is the leading cause of blindness in working-age adults. Studies have suggested that statins may reduce the risk of developing diabetic retinopathy. Objective:To investigate the association between statin therapy and the development of diabetic retinopathy in patients with diabetes and dyslipidemia. Design, Setting, and Participants:This population-based cohort study, conducted among 37?894 Taiwanese patients between January 1, 1998, and December 31, 2013, used the National Health Insurance Research Database to identify patients with type 2 diabetes and dyslipidemia. Outcomes were compared between those taking statins and those not taking statins. Statistical analysis was performed from May 1 to 31, 2018. Exposure:Statin therapy with a medication possession rate of 80% or more with no other lipid-lowering medications. Main Outcomes and Measures:Any stage of diabetic retinopathy and treatments for vision-threatening diabetic retinopathy. Results:Of 1?648?305 patients with type 2 diabetes, 219?359 were eligible for analysis over the study period, including 199?760 patients taking statins and 19?599 patients not taking statins. After propensity score matching, there were 18?947 patients in the statin group (10 436 women and 8511 men; mean [SD] age, 61.5 [10.8] years) and 18?947 patients in the nonstatin group (10 430 women and 8517 men; mean [SD] age, 61.0 [11.0] years), with a mean follow-up of 7.6 years for the statin group and 7.3 years for the nonstatin group. During the study period, 2004 patients in the statin group (10.6%) and 2269 patients in the nonstatin group (12.0%) developed diabetic retinopathy. Patients in the statin group had a significantly lower rate of diabetic retinopathy (hazard ratio [HR], 0.86; 95% CI, 0.81-0.91), nonproliferative diabetic retinopathy (HR, 0.92; 95% CI, 0.86-0.99), proliferative diabetic retinopathy (HR, 0.64; 95% CI, 0.58-0.70), vitreous hemorrhage (HR, 0.62; 95% CI, 0.54-0.71), tractional retinal detachment (HR, 0.61; 95% CI, 0.47-0.79), and macular edema (HR, 0.60; 95% CI, 0.46-0.79) than the nonstatin group, as well as lower rates of interventions such as retinal laser treatment (HR, 0.71; 95% CI, 0.65-0.77), intravitreal injection (HR, 0.74; 95% CI, 0.61-0.89), and vitrectomy (HR, 0.58; 95% CI, 0.48-0.69), along with a smaller number of the interventions (retinal lasers: rate ratio, 0.61; 95% CI, 0.59-0.64; intravitreal injections: rate ratio, 0.68; 95% CI, 0.61-0.76; and vitrectomies: rate ratio, 0.54; 95% CI, 0.46-0.63). Statin therapy was also associated with lower risks of major adverse cardiovascular events (HR, 0.81; 95% CI, 0.77-0.85), new-onset diabetic neuropathy (HR, 0.85; 95% CI, 0.82-0.89), and new-onset diabetic foot ulcers (HR, 0.73; 95% CI, 0.68-0.78). Conclusions and Relevance:Statin therapy was associated with a decreased risk of diabetic retinopathy and need for treatments for vision-threatening diabetic retinopathy in Taiwanese patients with type 2 diabetes and dyslipidemia.

SUBMITTER: Kang EY

PROVIDER: S-EPMC6459113 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Association of Statin Therapy With Prevention of Vision-Threatening Diabetic Retinopathy.

Kang Eugene Yu-Chuan EY Chen Tien-Hsing TH Garg Sunir J SJ Sun Chi-Chin CC Kang Je-Ho JH Wu Wei-Chi WC Hung Ming-Jui MJ Lai Chi-Chun CC Cherng Wen-Jin WJ Hwang Yih-Shiou YS

JAMA ophthalmology 20190401 4

<h4>Importance</h4>Diabetic retinopathy is the leading cause of blindness in working-age adults. Studies have suggested that statins may reduce the risk of developing diabetic retinopathy.<h4>Objective</h4>To investigate the association between statin therapy and the development of diabetic retinopathy in patients with diabetes and dyslipidemia.<h4>Design, setting, and participants</h4>This population-based cohort study, conducted among 37 894 Taiwanese patients between January 1, 1998, and Dece ...[more]

PMID: 30629109

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Project description:ImportanceDiabetic retinopathy (DR) may progress from nonproliferative DR (NPDR) to vision-threatening DR (VTDR). Studies have investigated fenofibrate use as a protective measure with conflicting results, and fenofibrate is not typically considered by ophthalmologists in the management of DR currently.ObjectiveTo assess the association between fenofibrate use and the progression from NPDR to VTDR, proliferative DR (PDR), or diabetic macular edema (DME).Design, setting, and participantsThis multicenter cohort study used medical claims data from a large US insurer. Cohorts were created from all patients with NPDR 18 years or older who had laboratory values from January 1, 2002, to June 30, 2019. Exclusion criteria consisted of any previous diagnosis of PDR, DME, proliferative vitreoretinopathy, or treatment used in the care of VTDR. Patients were also excluded if they had a diagnosis of VTDR within 2 years of insurance plan entry, regardless of when NPDR was first noted in the plan.ExposuresFenofibrate use.Main outcomes and measuresThe main outcomes were a new diagnosis of VTDR (a composite outcome of either PDR or DME) or DME and PDR individually. A time-updating model for all covariates was used in multivariate Cox proportional hazard regression to determine hazards of progressing to an outcome. Additional covariates included NPDR severity scale, systemic illnesses, demographics, kidney function (based on estimated glomerular filtration rate level), hemoglobin A1c, hemoglobin, and insulin use.ResultsA total of 5835 fenofibrate users with NPDR at baseline (mean [SD] age, 65.3 [10.4] years; 3564 [61.1%] male; 3024 [51.8%] White) and 144 417 fenofibrate nonusers (mean [SD] age, 65.7 [12.3] years; 73 587 [51.0%] male; 67 023 [46.4%] White) were included for analysis. Of these, 27 325 (18.2%) progressed to VTDR, 4086 (2.71%) progressed to PDR, and 22 750 (15.1%) progressed to DME. After controlling for all covariates, Cox model results showed fenofibrates to be associated with a decreased risk of VTDR (hazard ratio, 0.92 [95% CI, 0.87-0.98]; P = .01) and PDR (hazard ratio, 0.76 [95% CI, 0.64-0.90]; P = .001) but not DME (hazard ratio, 0.96 [95% CI, 0.90-1.03]; P = .27).Conclusions and relevanceIn this study, fenofibrate use was associated with a decreased risk of PDR and VTDR but not DME alone. These findings support the rationale for additional clinical trials to determine if these associations may be representative of a causal relationship between fenofibrate use and reduced risk of PDR or VTDR.

Project description:ImportanceDiabetic retinopathy (DR) is a leading cause of blindness in adults worldwide. Early detection and intervention can prevent blindness; however, many patients do not receive their recommended annual diabetic eye examinations, primarily owing to limited access.ObjectiveTo evaluate the safety and accuracy of an artificial intelligence (AI) system (the EyeArt Automated DR Detection System, version 2.1.0) in detecting both more-than-mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR).Design, setting, and participantsA prospective multicenter cross-sectional diagnostic study was preregistered (NCT03112005) and conducted from April 17, 2017, to May 30, 2018. A total of 942 individuals aged 18 years or older who had diabetes gave consent to participate at 15 primary care and eye care facilities. Data analysis was performed from February 14 to July 10, 2019.InterventionsRetinal imaging for the autonomous AI system and Early Treatment Diabetic Retinopathy Study (ETDRS) reference standard determination.Main outcomes and measuresPrimary outcome measures included the sensitivity and specificity of the AI system in identifying participants' eyes with mtmDR and/or vtDR by 2-field undilated fundus photography vs a rigorous clinical reference standard comprising reading center grading of 4 wide-field dilated images using the ETDRS severity scale. Secondary outcome measures included the evaluation of imageability, dilated-if-needed analysis, enrichment correction analysis, worst-case imputation, and safety outcomes.ResultsOf 942 consenting individuals, 893 patients (1786 eyes) met the inclusion criteria and completed the study protocol. The population included 449 men (50.3%). Mean (SD) participant age was 53.9 (15.2) years (median, 56; range, 18-88 years), 655 were White (73.3%), and 206 had type 1 diabetes (23.1%). Sensitivity and specificity of the AI system were high in detecting mtmDR (sensitivity: 95.5%; 95% CI, 92.4%-98.5% and specificity: 85.0%; 95% CI, 82.6%-87.4%) and vtDR (sensitivity: 95.1%; 95% CI, 90.1%-100% and specificity: 89.0%; 95% CI, 87.0%-91.1%) without dilation. Imageability was high without dilation, with the AI system able to grade 87.4% (95% CI, 85.2%-89.6%) of the eyes with reading center grades. When eyes with ungradable results were dilated per the protocol, the imageability improved to 97.4% (95% CI, 96.4%-98.5%), with the sensitivity and specificity being similar. After correcting for enrichment, the mtmDR specificity increased to 87.8% (95% CI, 86.3%-89.5%) and the sensitivity remained similar; for vtDR, both sensitivity (97.0%; 95% CI, 91.2%-100%) and specificity (90.1%; 95% CI, 89.4%-91.5%) improved.Conclusions and relevanceThis prospective multicenter cross-sectional diagnostic study noted safety and accuracy with use of the EyeArt Automated DR Detection System in detecting both mtmDR and, for the first time, vtDR, without physician assistance. These findings suggest that improved access to accurate, reliable diabetic eye examinations may increase adherence to recommended annual screenings and allow for accelerated referral of patients identified as having vtDR.

Dataset Information

Association of Statin Therapy With Prevention of Vision-Threatening Diabetic Retinopathy.

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Association of Statin Therapy With Prevention of Vision-Threatening Diabetic Retinopathy.

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