The role of patiromer: Comparing OPAL-HK data with untreated real-world patients in the United Kingdom-A retrospective, propensity-matched analysis

Objectives The first phase of the published OPAL-HK study was a single-group treatment phase, which showed that patiromer normalised serum potassium at 4weeks in patients with chronic kidney disease stages 3-4 who were receiving renin-angiotensin-aldosterone inhibitors. We utilised real-world data to provide a control comparison to evaluate patiromer's efficacy in lowering serum potassium. Materials and methods The Salford Kidney Study (SKS) in the United Kingdom provided a matched cohort. After applying OPAL-HK inclusion and exclusion criteria, patients with an outpatient potassium level between 5.1mmol/L to <6.5mmol/L and whose next outpatient level was checked 24-42 days later were selected. Patients underwent 1:1 matching with the 243 OPAL-HK patients using propensity matching based on 6 variables: age, gender, estimated glomerular filtration rate, diabetes, heart failure and potassium level. The study outcomes aligned with the OPAL-HK treatment phase: mean change in baseline potassium, and the proportion of patients with a potassium of 3.8 to Results The study comprised 87 precisely matched patients. The mean follow-up in the 87 SKS patients was 31 +/- 5 days. At baseline, matched patients had a mean potassium of 5.5 +/- 0.3mmol/L. At follow-up, the mean level was unchanged in SKS patients but was 4.5 +/- 0.5mmol/L in the OPAL-HK group (p<0.001), a mean (+/- SE) change of -1.00 +/- 0.06mmol/L. The target range of 3.8 to Conclusions Using real-world data as a matched control arm for the first phase of the OPAL-HK study, we highlight a potential role for patiromer in lowering potassium levels in patients with CKD 3-4 receiving renin-angiotensin-aldosterone inhibitors.