July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Association of Macular Disease with Long-term Use of Pentosan Polysulfate Sodium: Findings from a Large U.S. National Insurance Database
Author Affiliations & Notes
  • Alexa L Li
    Ophthalmology, Emory Eye Center, Atlanta, Georgia, United States
  • Nieraj Jain
    Ophthalmology, Emory Eye Center, Atlanta, Georgia, United States
  • Yinxi Yu
    Ophthalmology, Scheie Eye Institute University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Brian L VanderBeek
    Ophthalmology, Scheie Eye Institute University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Footnotes
    Commercial Relationships   Alexa Li, None; Nieraj Jain, None; Yinxi Yu, None; Brian VanderBeek, None
  • Footnotes
    Support  NEI Grants 1K23EY025729-01 and 2P30EY001583; Foundation Fighting Blindness CD-C-0918-0748-EEC (NJ)
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 5044. doi:
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    • Get Citation

      Alexa L Li, Nieraj Jain, Yinxi Yu, Brian L VanderBeek; Association of Macular Disease with Long-term Use of Pentosan Polysulfate Sodium: Findings from a Large U.S. National Insurance Database. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5044.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : We recently described a unique pigmentary maculopathy in the setting of chronic exposure to pentosan polysulfate sodium (PPS), a treatment for interstitial cystitis. In all affected patients, these pigmentary changes were previously ascribed to a diagnosis of dry macular degeneration or pattern dystrophy. Herein, we performed a retrospective review of medical claims data from a national U.S. insurer to determine if long-term PPS usage is linked to diagnoses of varying macular disorders in a large U.S. population.

Methods : A retrospective, matched cohort study using data from a medical claims database was performed. The exposure cohort consisted of all patients prescribed PPS from 2002-2011. The index date was the date when the patient first filled a prescription for PPS, and patients were required to have at least 2 years prior to and 5 years after the index date for inclusion. Controls were matched 5:1 for age, gender, race, insurance plan eligibility start/end date and were assigned the same index date their exposed match. Exclusion occurred for being <18 years old and any dry macular degeneration (dAMD) or drusen diagnosis prior to the index date. The primary outcome was defined as a new International Classification of Disease (ICD-9/10) diagnosis code for a hereditary or secondary pigmentary retinopathy with a secondary outcome also including a new diagnosis of dAMD or drusen. Multivariate logistic regression analyses were performed controlling for demographic and systemic health variables.

Results : 1187 PPS users and 5939 controls met the eligibility criteria. At the 5-year follow-up, 5(0.4%) and 71(6.0%) PPS patients compared to 16(0.3%) and 266(4.5%) control patients progressed to the primary and secondary outcomes respectively. Multivariate analysis showed no significant association for PPS and the primary outcome (OR=1.49, 95% CI:0.54-4.11, P=0.45); however, exposure to PPS significantly increased the odds of having a secondary outcome (OR=1.39, 95% CI:1.04–1.85, P=0.03).

Conclusions : PPS exposure was associated with a new diagnosis of macular disease at the 5-year follow-up in a large national cohort. These results corroborate findings of the initial case series that suggested an association between PPS exposure and a novel maculopathy, although the association was noted at a lower exposure duration than in the index cases.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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