Evidence map›Paper›PMID 39787060›Full record

ArticlePloS one2025

Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium.

Zhong Yuan, Subusola Vaughan, Carolyn Jeffcoat, Peter Hu, Ritchie Yuson, Daniel Fife, Durga Borkar

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Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Zhong YuanJanssen Research & Development, Global Epidemiology, Horsham, PA, United States of America.ORCID 0000-0002-5824-2040
Subusola VaughanJanssen Research & Development, Titusville, NJ, United States of America.
Carolyn JeffcoatJanssen Research & Development, Horsham, PA, United States of America.
Peter HuJanssen Research & Development, Statistics and Decision Science, Raritan, NJ, United States of America.
Ritchie YusonJohnson and Johnson Surgical Vision, Irvine, CA, United States of America.
Daniel FifeJanssen Research & Development, Global Epidemiology, Titusville, PA, United States of America.
Durga BorkarVerana Health, San Francisco, CA, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo 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.

methodsThis 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.

resultsPrevalence 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.

conclusionPrevalence 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.

Indexed as

Cystitis, InterstitialMacular DegenerationPentosan Sulfuric PolyesterAdultAgedFemaleHumansIncidenceMaleMiddle AgedPrevalenceRetinal DiseasesRetrospective StudiesVisual AcuityPentosan Sulfuric Polyester

Identifiers

PMID39787060
PMCPMC11717312

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.