Prevalence and Dose Dependency Analysis of Pentosan Polysulfate Sodium Maculopathy

• Published in: Ophthalmic epidemiology 2023-01, Vol.30 (1), p.82-87
• Main Authors: Philip, Andrew M., Wannamaker, Kendall W., Miller, Daniel M.
• Format: Article
• Language: English
• Subjects: dose; Elmiron; Humans; Macular Degeneration - chemically induced; Macular Degeneration - diagnosis; Macular Degeneration - epidemiology; maculopathy; Pentosan polysulfate; Pentosan Sulfuric Polyester - adverse effects; Prevalence; Retinal Diseases; Retrospective Studies; toxicity
• ISSN: 0928-6586; 1744-5086
• DOI: 10.1080/09286586.2022.2031227

We describe a retrospective cohort study investigating the prevalence of pentosan polysulfate sodium (PPS) maculopathy in patients with PPS exposure, as well as the relationship between cumulative PPS exposure and the presence of PPS-maculopathy. Patients were identified through review of the electronic medical record system. Available diagnostic imaging was reviewed for signs of PPS-maculopathy. Patients were also contacted to determine cumulative exposure. Of the 335 identified eligible patient records, 84 had sufficient diagnostic imaging. Sixteen patients had definitive signs of PPS-maculopathy, 6 had likely signs of PPS-maculopathy, and 62 had no signs. The mean cumulative PPS exposure and standard error of the mean (SEM) for patients with any signs of PPS-maculopathy was 1946.0 g (396.0 g), significantly higher than the mean cumulative PPS exposure for patients without such signs of 782.3 g (105.3 g). No significant difference in BCVA was noted. The odds ratio (OR, 95% confidence interval (95% CI)) of PPS-maculopathy was significantly elevated in patients with cumulative PPS exposures of 1500-2000 g [OR 4.72 (0.856-26.02 95% CI)] and greater than 2000 g [OR 28.33 (2.388-336.1, 95% CI)]. Logistic regression analysis confirmed a positive dose response relationship. We describe the concerning incidence of PPS-maculopathy in a multispecialty ophthalmology practice's patient population and investigate the dose-dependency of PPS-maculopathy. Patients with PPS-maculopathy were shown to have a higher average exposure to PPS than those without the maculopathy. Patients with cumulative PPS exposures greater than 1500 g were shown to have an increased risk of PPS-maculopathy.