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

Ibrahim Ali,Philip A Kalra,Georgiana Cornea,Rajkumar Chinnadurai,Michele Intorcia,Jaap A Joles

doi:10.1371/journal.pone.0237467

Ibrahim Ali, Philip A Kalra + Show 4 more

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https://doi.org/10.1371/journal.pone.0237467

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Abstract

ObjectivesThe 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 methodsThe 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 <5.1mmol/L at follow-up.ResultsThe 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 <5.1mmol/L was reached in 80% of OPAL-HK patients compared with 0% in the SKS cohort. There were very few interventions undertaken to reduce hyperkalaemia in SKS patients.ConclusionsUsing 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.

Highlights

Hyperkalaemia is an important electrolyte disturbance that most commonly occurs in patients with advanced chronic kidney disease (CKD) [1]
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
The mean follow-up in the matched Salford Kidney Study (SKS) cohort was 31±5 days. In both SKS and OPAL-HK patients, the mean baseline potassium level was identical at 5.5±0.3mmol/L

Summary

Introduction

Hyperkalaemia is an important electrolyte disturbance that most commonly occurs in patients with advanced chronic kidney disease (CKD) [1]. Achieving normokalaemia in the outpatient setting whilst maintaining RAASi may be achieved through a combination of measures including low-potassium dietary advice, addition of a loop or thiazide diuretic, correction of acidosis with sodium bicarbonate and with potassium binders such as sodium polystyrene sulfonate (SPS). This latter intervention, beset by a lack of evidence for long-term use and the significant risk of gastrointestinal side effects [4], has been transformed thanks to the introduction of new oral potassium-binding agents such as patiromer. Sodium-free potassium-binding polymer that non- binds potassium for calcium along the gastrointestinal tract, facilitating potassium excretion

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