Jonathan C Tsui, Keirnan Willett, Jordana B Cohen, Yinxi Yu, Brian L VanderBeek
{"title":"促红细胞生成素与危及视力的糖尿病视网膜病变风险。","authors":"Jonathan C Tsui, Keirnan Willett, Jordana B Cohen, Yinxi Yu, Brian L VanderBeek","doi":"10.1080/09286586.2023.2235001","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Animal studies have suggested that Erythropoiesis-Stimulating Agents (ESAs) may increase vascular endothelial growth factor (VEGF)-related retinopathies, but this effect is unclear in humans. This study evaluates the risk of vision-threatening diabetic retinopathy (VTDR), defined as either diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR), in patients exposed to an ESA.</p><p><strong>Methods: </strong>Two analyses were performed. First, a retrospective matched-cohort study was designed using a de-identified commercial and Medicare Advantage medical claims database. The ESA cohort of non-proliferative diabetic retinopathy patients who were new users of an ESA from 2000 to 2022 was matched to controls up to a 3:1 ratio. Exclusion criteria included less than 2 years in the plan, history of VTDR or history of other retinopathy. Multivariable Cox proportional hazards regression with inverse proportional treatment weighting (IPTW) was used to assess the hazard of developing VTDR, DME, and PDR. The second analysis was a self-controlled case series (SCCS) evaluating the incidence rate ratios (IRR) of VTDR during 30-day periods before and after initiating an ESA.</p><p><strong>Results: </strong>After inclusion of 1502 ESA-exposed patients compared with 2656 controls, IPTW-adjusted hazard ratios found the ESA cohort had an increased hazard of progressing to VTDR (HR = 3.0 95%CI:2.3-3.8;<i>p</i> < .001) and DME (HR = 3.4,95%CI:2.6-4.4,<i>p</i> < .001), but not PDR (HR = 1.0,95%CI:0.5-2.3,<i>p</i> = .95). Similar results were found within the SCCS which demonstrated higher IRRs for VTDR (IRRs = 1.09-1.18;<i>p</i> < .001) and DME (IRRs = 1.16-1.18;<i>p</i> < .001), but not increased IRRs in PDR (IRR = 0.92-0.97,<i>p</i> = .02-0.39).</p><p><strong>Conclusion: </strong>ESAs are associated with higher risks for VTDR and DME, but not PDR. Those studying ESAs as adjunctive therapy for DR should be cautious of possible unintended effects.</p>","PeriodicalId":19607,"journal":{"name":"Ophthalmic epidemiology","volume":" ","pages":"249-257"},"PeriodicalIF":1.7000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10776797/pdf/","citationCount":"0","resultStr":"{\"title\":\"Erythropoiesis-Stimulating Agents and the Risk of Vision-Threatening Diabetic Retinopathy.\",\"authors\":\"Jonathan C Tsui, Keirnan Willett, Jordana B Cohen, Yinxi Yu, Brian L VanderBeek\",\"doi\":\"10.1080/09286586.2023.2235001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Animal studies have suggested that Erythropoiesis-Stimulating Agents (ESAs) may increase vascular endothelial growth factor (VEGF)-related retinopathies, but this effect is unclear in humans. This study evaluates the risk of vision-threatening diabetic retinopathy (VTDR), defined as either diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR), in patients exposed to an ESA.</p><p><strong>Methods: </strong>Two analyses were performed. First, a retrospective matched-cohort study was designed using a de-identified commercial and Medicare Advantage medical claims database. The ESA cohort of non-proliferative diabetic retinopathy patients who were new users of an ESA from 2000 to 2022 was matched to controls up to a 3:1 ratio. Exclusion criteria included less than 2 years in the plan, history of VTDR or history of other retinopathy. Multivariable Cox proportional hazards regression with inverse proportional treatment weighting (IPTW) was used to assess the hazard of developing VTDR, DME, and PDR. The second analysis was a self-controlled case series (SCCS) evaluating the incidence rate ratios (IRR) of VTDR during 30-day periods before and after initiating an ESA.</p><p><strong>Results: </strong>After inclusion of 1502 ESA-exposed patients compared with 2656 controls, IPTW-adjusted hazard ratios found the ESA cohort had an increased hazard of progressing to VTDR (HR = 3.0 95%CI:2.3-3.8;<i>p</i> < .001) and DME (HR = 3.4,95%CI:2.6-4.4,<i>p</i> < .001), but not PDR (HR = 1.0,95%CI:0.5-2.3,<i>p</i> = .95). Similar results were found within the SCCS which demonstrated higher IRRs for VTDR (IRRs = 1.09-1.18;<i>p</i> < .001) and DME (IRRs = 1.16-1.18;<i>p</i> < .001), but not increased IRRs in PDR (IRR = 0.92-0.97,<i>p</i> = .02-0.39).</p><p><strong>Conclusion: </strong>ESAs are associated with higher risks for VTDR and DME, but not PDR. 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引用次数: 0
摘要
目的:动物实验表明,促红细胞生成素(ESAs)可能会增加与血管内皮生长因子(VEGF)相关的视网膜病变,但这种影响在人类身上尚不明确。本研究评估了暴露于ESA的患者发生危及视力的糖尿病视网膜病变(VTDR)的风险,VTDR定义为糖尿病黄斑水肿(DME)或增殖性糖尿病视网膜病变(PDR):进行了两项分析。首先,利用去标识化的商业和医疗保险优势医疗索赔数据库设计了一项回顾性匹配队列研究。将 2000 年至 2022 年期间新使用 ESA 的非增生性糖尿病视网膜病变患者组成的 ESA 队列与对照组进行配对,配对比例为 3:1。排除标准包括参加计划不足 2 年、有 VTDR 病史或其他视网膜病变病史。采用逆比例治疗加权(IPTW)的多变量考克斯比例危险度回归来评估罹患 VTDR、DME 和 PDR 的危险度。第二项分析是自控病例系列(SCCS),评估开始使用ESA前后30天内VTDR的发病率比(IRR):结果:在纳入1502名暴露于ESA的患者与2656名对照组患者后,经IPTW调整的危险比发现,ESA队列患者发展为VTDR的危险增加(HR = 3.0 95%CI:2.3-3.8;p p = .95)。在SCCS中也发现了类似的结果,VTDR的IRRs更高(IRRs = 1.09-1.18;P P = .02-0.39):结论:ESAs 与较高的 VTDR 和 DME 风险相关,但与 PDR 无关。结论:ESAs 与较高的 VTDR 和 DME 风险有关,但与 PDR 无关。将 ESAs 作为 DR 辅助疗法的研究人员应谨慎对待可能出现的意外影响。
Erythropoiesis-Stimulating Agents and the Risk of Vision-Threatening Diabetic Retinopathy.
Purpose: Animal studies have suggested that Erythropoiesis-Stimulating Agents (ESAs) may increase vascular endothelial growth factor (VEGF)-related retinopathies, but this effect is unclear in humans. This study evaluates the risk of vision-threatening diabetic retinopathy (VTDR), defined as either diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR), in patients exposed to an ESA.
Methods: Two analyses were performed. First, a retrospective matched-cohort study was designed using a de-identified commercial and Medicare Advantage medical claims database. The ESA cohort of non-proliferative diabetic retinopathy patients who were new users of an ESA from 2000 to 2022 was matched to controls up to a 3:1 ratio. Exclusion criteria included less than 2 years in the plan, history of VTDR or history of other retinopathy. Multivariable Cox proportional hazards regression with inverse proportional treatment weighting (IPTW) was used to assess the hazard of developing VTDR, DME, and PDR. The second analysis was a self-controlled case series (SCCS) evaluating the incidence rate ratios (IRR) of VTDR during 30-day periods before and after initiating an ESA.
Results: After inclusion of 1502 ESA-exposed patients compared with 2656 controls, IPTW-adjusted hazard ratios found the ESA cohort had an increased hazard of progressing to VTDR (HR = 3.0 95%CI:2.3-3.8;p < .001) and DME (HR = 3.4,95%CI:2.6-4.4,p < .001), but not PDR (HR = 1.0,95%CI:0.5-2.3,p = .95). Similar results were found within the SCCS which demonstrated higher IRRs for VTDR (IRRs = 1.09-1.18;p < .001) and DME (IRRs = 1.16-1.18;p < .001), but not increased IRRs in PDR (IRR = 0.92-0.97,p = .02-0.39).
Conclusion: ESAs are associated with higher risks for VTDR and DME, but not PDR. Those studying ESAs as adjunctive therapy for DR should be cautious of possible unintended effects.
期刊介绍:
Ophthalmic Epidemiology is dedicated to the publication of original research into eye and vision health in the fields of epidemiology, public health and the prevention of blindness. Ophthalmic Epidemiology publishes editorials, original research reports, systematic reviews and meta-analysis articles, brief communications and letters to the editor on all subjects related to ophthalmic epidemiology. A broad range of topics is suitable, such as: evaluating the risk of ocular diseases, general and specific study designs, screening program implementation and evaluation, eye health care access, delivery and outcomes, therapeutic efficacy or effectiveness, disease prognosis and quality of life, cost-benefit analysis, biostatistical theory and risk factor analysis. We are looking to expand our engagement with reports of international interest, including those regarding problems affecting developing countries, although reports from all over the world potentially are suitable. Clinical case reports, small case series (not enough for a cohort analysis) articles and animal research reports are not appropriate for this journal.