Pentosan Polysulfate Sodium Exposure and Drug-Induced Maculopathy in Commercially Insured Patients in the United States

Ludwig, Cassie A.; Vail, Daniel; Callaway, Natalia F.; Pasricha, Malini Veerappan; Moshfeghi, Darius M.

doi:10.1016/j.ophtha.2019.10.036

Cited by 35 publications

(31 citation statements)

References 10 publications

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“…11 While several studies have shown the association of PPS to a maculopathy, some studies have discussed the possibility of IC causing the maculopathy itself. 12,13 Given these findings, we conducted a retrospective chart review at our institution to look for evidence of retinal pathology in patients with PPS. Our suspect group was found to have been taking PPS for an average of 4.2 years and an average dosage 380g respectively while the non-suspect group took it for an average of 3.6 years at 442g.…”

Section: Discussionmentioning

confidence: 99%

Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience

Kalbag¹,

Maganti²,

Lyon³

et al. 2021

OPTH

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Aim: To investigate the prevalence of retinal pathology in patients with a history of exposure to pentosan polysulfate sodium (PPS). Methods: Patients exposed to PPS and seen in the ophthalmology clinic at Northwestern University during 1/1/2002 to 1/1/2019 were identified from electronic health records (EHR) by an electronic data warehouse (EDW) search. Visual acuity (VA), reasons for clinic visit, ocular conditions, and duration of exposure to PPS were noted. Chart review was performed for fundus exam findings and ophthalmologic imaging, specifically fundus photography, fundus autofluorescence, and ocular coherence tomography (OCT) images. When OCT or fundus photography was available, studies were evaluated by two independent graders. Results: A total of 131 patients who were exposed to PPS and seen at the Northwestern Ophthalmology clinic were identified in the EHR. Forty patients of 131 had imaging. Patients with imaging or fundus examination suspicious for PPS maculopathy were placed into the suspect group. Of the 40 patients that had imaging, 5 (12.5%) had features suspicious for PPS maculopathy. Of the remaining 91, 5 (5.4%) had macular pigmentary changes described on fundus exam. Among the 10 patients in the suspect group, the average duration of PPS use was 4.2 years (range 0.3-11.6 years, interquartile range 5.5 years) and the average cumulative dose was 380g (range 29-1092g, interquartile range 132g). Conclusion: A novel drug-induced maculopathy has been associated with PPS use with a distinct clinical constellation that can be accurately identified with multimodal imaging.

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Section: Discussionmentioning

confidence: 99%

Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience

Kalbag¹,

Maganti²,

Lyon³

et al. 2021

OPTH

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“…In order to minimize potential distortion, magnification, and rotation between fundus autofluorescence images obtained on different machines, the average of 3 measurements, measured in vertical disc diameters, was used. 16 …”

Section: Methodsmentioning

confidence: 99%

Pentosan Polysulfate Sodium-Associated Pigmentary Retinopathy: Risk Factors and Fundus Findings

Leung¹,

Sharma²,

Levie-Sprick³

et al. 2021

OPTH

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Purpose To evaluate the risk factors and fundus findings of patients with potential PPS-associated retinopathy. Patients and Methods A retrospective chart review was performed of patients exposed to PPS who had a dilated fundus examination at a large retina-only practice from 2018–21. Multimodal images were evaluated by masked reviewers. Results A total of 148 patients were included, of whom 33 (22%) had PPS-associated retinopathy, and 115 (78%) did not. The mean age was 60.3 years old, and the mean follow-up was 11.8 months. The PPS-associated retinopathy group had higher mean cumulative doses of PPS (1600g±849 vs 864g±852, P < 0.0001, Mann–Whitney test) and longer duration of PPS use (13.6 years vs 7.48, P < 0.0001). There was no statistically significant difference based on a history of kidney or liver disease or the dosage per day for the weight, body mass index, body surface area, or lean body weight. Of the patients with PPS-associated retinopathy whose genetic results were available, 15 of 16 (93%) were heterozygous for variants of uncertain significance. Conclusion A longer duration of PPS use and higher cumulative dosage of PPS were associated with an increased risk of developing PPS-associated pigmentary retinopathy. The role of genetic mutations in patients exposed to PPS is still to be determined.

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“…However, the association between PPS and maculopathy is still somewhat controversial. Ludwig et al reviewed a cohort of 227,325 patients with interstitial cystitis and treated with PPS and did not find an exposure or a dose-dependent relationship with less than 1 year of PPS use; there was, however, a possible dose-dependent relationship with greater than 4 years of use and an increased risk of diagnosed with a hereditary dystrophy [ 21 ]. A retrospective matched cohort study by Jain et al looked for an association in a large national cohort, and found that PPS exposure was associated with a diagnosis of atypical maculopathy and age-related macular degeneration (AMD) at the 7-year follow-up [ 22 ].…”

Section: Pentosan Polysulfate Sodiummentioning

confidence: 99%

Update on Retinal Drug Toxicities

Hsu

Ponugoti

Deaner

et al. 2021

Curr Ophthalmol Rep

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Purpose of Review This review aims to provide an update on the clinical presentations and diagnostic findings of drug-induced retinal toxicities. Recent Findings Several newly FDA-approved medications have been associated with acute retinal toxicities, including brolucizumab, MEK inhibitors, ulixertinib, and FGFR inhibitors. Additionally, as previously believed-to-be well-tolerated medications, such as pentosan sulfate sodium, anti-retroviral therapies, and certain intraoperative ocular medications, are used more frequently or for longer periods of time, associated toxic retinopathies and inflammatory reactions have been reported. Finally, advances in ocular imaging have revealed novel findings in hydroxychloroquine and tamoxifen maculopathies. Summary Discovery of new medications, increased frequency of use, and longer-term use have led to increased reports of retinal toxicities. Advances in retinal imaging have allowed for earlier detection of subclinical changes associated with these medications, which may help prevent progression of disease. However, more research is needed to determine the point at which vision loss becomes irreversible. Risks and benefits must be assessed prior to discontinuation of the offending, but potentially lifesaving, therapy.

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Pentosan Polysulfate Sodium Exposure and Drug-Induced Maculopathy in Commercially Insured Patients in the United States

Cited by 35 publications

References 10 publications

Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience

Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience

Pentosan Polysulfate Sodium-Associated Pigmentary Retinopathy: Risk Factors and Fundus Findings

Update on Retinal Drug Toxicities

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