Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium.
<h4>Purpose</h4>To evaluate prevalence and incidence rates of pigmentary maculopathy and retinopathy (PM/PR), and visual acuity (VA) changes in patients exposed to pentosan polysulfate sodium (PPS) and in patients with interstitial cystitis (IC) not exposed to PPS.<h4>Methods</h...
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Public Library of Science (PLoS)
2025-01-01
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Online Access: | https://doi.org/10.1371/journal.pone.0313497 |
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author | Zhong Yuan Subusola Vaughan Carolyn Jeffcoat Peter Hu Ritchie Yuson Daniel Fife Durga Borkar |
author_facet | Zhong Yuan Subusola Vaughan Carolyn Jeffcoat Peter Hu Ritchie Yuson Daniel Fife Durga Borkar |
author_sort | Zhong Yuan |
collection | DOAJ |
description | <h4>Purpose</h4>To evaluate prevalence and incidence rates of pigmentary maculopathy and retinopathy (PM/PR), and visual acuity (VA) changes in patients exposed to pentosan polysulfate sodium (PPS) and in patients with interstitial cystitis (IC) not exposed to PPS.<h4>Methods</h4>This is a retrospective cohort study (January 2015-March 2021) which included adult de-identified patients from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) and Komodo Health database. Three patient cohorts were identified: two PPS-exposed patient cohorts, and Non-PPS-exposed IC patient cohort. Key study outcomes included PM/PR/Any (defined based on prior literature regardless of PPS exposure) and PM/PR/PPS (further defined by an algorithm that was based on clinical notes and other protocol-prespecified criteria in PPS-exposed patients), and VA changes in each respective cohort.<h4>Results</h4>Prevalence of PM/PR/Any was relatively common in patients prior to PPS exposure (4.16%-8.43%). Incidence rate of PM/PR/PPS was uncommon in both PPS-exposed cohorts (0.13-0.15 per 100 person-years). Crude incidence rates of PM/PR/Any (based on ITT analysis) varied slightly across 3 study cohorts (2.13-2.81 and 2.38 per 100-person-years for PPS-exposed cohorts and Non-PPS-exposed IC cohort, respectively). Across all 3 study cohorts, patients with PM/PR/Any appeared to have approximately 2-fold higher proportion of 3 lines of VA worsening than those without PM/PR/Any.<h4>Conclusion</h4>Prevalence of PM/PR was common in patients prior to PPS exposure. Incidence of PM/PR/PPS that may be associated with PPS exposure was relatively uncommon. Crude incidence rates of PM/PR appeared similar across all patient cohorts regardless of PPS exposure. |
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institution | Kabale University |
issn | 1932-6203 |
language | English |
publishDate | 2025-01-01 |
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spelling | doaj-art-5dc2c24584e94ab48bb4e7650be009ec2025-01-17T05:31:32ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01201e031349710.1371/journal.pone.0313497Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium.Zhong YuanSubusola VaughanCarolyn JeffcoatPeter HuRitchie YusonDaniel FifeDurga Borkar<h4>Purpose</h4>To evaluate prevalence and incidence rates of pigmentary maculopathy and retinopathy (PM/PR), and visual acuity (VA) changes in patients exposed to pentosan polysulfate sodium (PPS) and in patients with interstitial cystitis (IC) not exposed to PPS.<h4>Methods</h4>This is a retrospective cohort study (January 2015-March 2021) which included adult de-identified patients from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) and Komodo Health database. Three patient cohorts were identified: two PPS-exposed patient cohorts, and Non-PPS-exposed IC patient cohort. Key study outcomes included PM/PR/Any (defined based on prior literature regardless of PPS exposure) and PM/PR/PPS (further defined by an algorithm that was based on clinical notes and other protocol-prespecified criteria in PPS-exposed patients), and VA changes in each respective cohort.<h4>Results</h4>Prevalence of PM/PR/Any was relatively common in patients prior to PPS exposure (4.16%-8.43%). Incidence rate of PM/PR/PPS was uncommon in both PPS-exposed cohorts (0.13-0.15 per 100 person-years). Crude incidence rates of PM/PR/Any (based on ITT analysis) varied slightly across 3 study cohorts (2.13-2.81 and 2.38 per 100-person-years for PPS-exposed cohorts and Non-PPS-exposed IC cohort, respectively). Across all 3 study cohorts, patients with PM/PR/Any appeared to have approximately 2-fold higher proportion of 3 lines of VA worsening than those without PM/PR/Any.<h4>Conclusion</h4>Prevalence of PM/PR was common in patients prior to PPS exposure. Incidence of PM/PR/PPS that may be associated with PPS exposure was relatively uncommon. Crude incidence rates of PM/PR appeared similar across all patient cohorts regardless of PPS exposure.https://doi.org/10.1371/journal.pone.0313497 |
spellingShingle | Zhong Yuan Subusola Vaughan Carolyn Jeffcoat Peter Hu Ritchie Yuson Daniel Fife Durga Borkar Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. PLoS ONE |
title | Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. |
title_full | Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. |
title_fullStr | Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. |
title_full_unstemmed | Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. |
title_short | Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. |
title_sort | retrospective study of incidence prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium |
url | https://doi.org/10.1371/journal.pone.0313497 |
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