Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium

Yuan Z, Vaughan S, Jeffcoat C, Hu P, Yuson R, Fife D, Borkar D · PLoS One

The manufacturer-linked counterweight: pigmentary maculopathy/retinopathy codes were common before PPS exposure ever began (4.2–8.4% prevalence), crude incidence was similar in PPS users and unexposed cystitis patients, and algorithm-confirmed PPS-attributable cases were rare, at 0.13–0.15 per 100 person-years.

Population

3,632 US patients first dispensed PPS from May 2018 and 14,053 with any PPS dispensing from 2015, plus 48,546 interstitial-cystitis patients never exposed, cross-linked ophthalmology-registry (IRIS) and Komodo claims data

Intervention

Oral PPS in routine US practice

Comparator

Non-PPS-exposed interstitial-cystitis patients

Limitations

Five authors are Janssen (Elmiron's maker) employees or J&J shareholders and a sixth a former employee, with Janssen writing support; diagnosis-code outcomes without imaging adjudication are poorly suited to detecting a distinctive phenotype; exposure is visible only from 2015, and 14 patients in the whole cohort and none in the recent one had cumulative exposure above 1,000 g, where the case series that defined the maculopathy sit.