Efficacy and safety of pentosan polysulfate sodium in people with symptomatic knee osteoarthritis and dyslipidaemia: protocol of the MaRVeL trial

Siddiq MAB, Liu X, Fedorova T, Bracken K, Virk S, Venkatesha V, Farivar A, Oo WM, Linklater J, Hill DC, Hunter DJ · BMJ Open

A published protocol for the first investigator-initiated knee-OA trial of PPS, sponsored by the University of Sydney rather than Paradigm, and the first to test the oral route against a modern pain endpoint: 16-week change in average knee pain on an 11-point numeric rating scale, with structural and functional secondary outcomes. Registered as ACTRN12621000654853; enrolment began June 2023.

Population

92 adults aged 40+ with painful Kellgren-Lawrence grade 2–3 knee OA and dyslipidaemia, Royal North Shore Hospital, Sydney

Intervention

Oral PPS 10 mg/kg twice weekly in two 5-week cycles, beginning at baseline and week 11 (Arthropharm 300 mg capsules against matched placebo)

Comparator

Placebo

Limitations

A protocol, not a result — no outcome data exist; single-centre and modest in size, and the dyslipidaemia entry criterion tests the vascular-mechanism hypothesis rather than knee OA in general. Arthropharm, a PPS company, supplies the drug and placebo free, has an author on the paper, and will run the exploratory biomarker assays in its own laboratory.