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

14,053 US PPS users plus 48,546 interstitial-cystitis patients never exposed, cross-linked ophthalmology-registry and 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; diagnosis-code outcomes without imaging adjudication are poorly suited to detecting a distinctive phenotype.