Identifying risk factors and timing of maculopathy in pentosan polysulfate sodium users: Insights from the Korean national health insurance database

초록

Introduction & Objectives: Recent studies analyzing insurance claims data have shown a potential link between pentosan polysulfatesodium (PPS) exposure and maculopathy, yet patient-specific risk factors and the timeline of maculopathy onset remain unclear. This studyaimed to identify risk factors for maculopathy in PPS-exposed patients and to establish the timeline of its onset using data from the KoreanNational Health Insurance Database. Materials & Methods: A cohort analysis of the Korean National Health Insurance Database was conducted from 2003 to 2020, includingPPS-exposed patients and matched controls by age and sex. Exclusions were made for pre-existing maculopathy, age under 18, and followup duration under 1 year. Cox regression analysis was applied to estimate hazard ratios (HR) for maculopathy in the PPS group compared tocontrols. This study received approval from the Ethical Committee of the Korea University Hospital. Results: In 48 (27%) patients /mean age 46.9±14.3/ from the group A and in 5 (9.6%) patients from group C /mean age 34.4±9.5/the distalcavernous density was greatly higher in comparison to proximal, with a mean distal/proximal density ratio (DPDR) of 1.45 and 1.36accordingly. There was found no significant correlation between DPDR and patients’ age (r=0.22 p>0.05), as well as no association with EDseverity, peak systolic velocity, resistive index or hardness score. Meanwhile, blood test results revealed strong positive correlation of DPDRwith the plasma total cholesterol (r=0.58; p<0.001)and LDL (r=0.61; p<0.001) levels. Conclusions: PPS exposure is associated with an elevated risk of maculopathy, particularly in patients with diabetes, peripheral vasculardisease, or myocardial infarction. The significantly increased incidence after 5 years suggests that long-term ophthalmologic monitoring maybe essential, especially for high-risk individuals.