Association between Pentosan Polysulfate and Subsequent Maculopathy: Insights from a Nationwide Population-Based Study in Korea.

Abstract

Purpose: To determine the association between pentosan polysulfate (PPS) use and the subsequent development of maculopathy in an Asian population.

Design: A nationwide, population-based retrospective cohort study using the Health Insurance Review and Assessment Service database.

Participants: A total of 103 553 individuals in the PPS user group and 205 792 individuals in the PPS nonuser group, all newly diagnosed with cystitis between 2009 and 2020.

Methods: The association between PPS use and maculopathy was evaluated using a time-dependent Cox proportional hazard model. Additionally, 2 sensitivity analyses were conducted by defining PPS users as individuals with an observation period over 6 months from the initial prescription or those with a cumulative dose exceeding 9 g, using the same analysis.

Main outcome measures: The outcome measures included the hazard ratios (HRs) representing the association between PPS use and maculopathy.

Results: Use of PPS was associated with an increased risk of subsequent maculopathy in univariate (HR, 1.7; 95% confidence interval [CI], 1.66-1.75) and multivariate analysis (HR, 1.34; 95% CI, 1.31-1.38). These results were also confirmed in 2 sensitivity analyses. The mean cumulative dose of PPS for the cohort was 37.2 ± 76.7 g.

Conclusions: In this nationwide cohort study involving an Asian population, individuals with cystitis using PPS exhibit an increased risk of developing subsequent maculopathy.

Financial disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.