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. 2020 Aug 27;15(8):e0237467.
doi: 10.1371/journal.pone.0237467. eCollection 2020.

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

Ibrahim Ali  1 , Rajkumar Chinnadurai  1 , Georgiana Cornea  2 , Michele Intorcia  2 , Philip A Kalra  1
Affiliations

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

Ibrahim Ali et al. PLoS One. .

Abstract

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 <5.1mmol/L at follow-up.

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 <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.

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.

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Conflict of interest statement

PK received research grants and speaker/consultancy fees from Vifor Fresenius Medical Care Renal Pharma outside the submitted work. GC is an employee and holds shares of the Vifor Pharma Group. MI was an employee of the Vifor Pharma Group from September 2018 to May 2020. Vifor Pharma markets patiromer. These declarations do not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Patient selection from the Salford kidney study.
Fig 2
Fig 2. Change in mean potassium level from baseline to follow-up.
* Follow-up was at 4 weeks in OPAL-HK. In SKS, mean follow-up time was 31±5 days.
Fig 3
Fig 3. Proportion of patients in potassium range 3.8 to <5.1mmol/L at follow-up.
See this image and copyright information in PMC

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