TY - JOUR
T1 - The role of patiromer: comparing OPAL-HK data with untreated real-world patients in the United Kingdom - a retrospective, propensity-matched analysis
AU - Ali, Ibrahim
AU - Chinnadurai, Rajkumar
AU - Cornea, Georgiana
AU - Intorcia, Michele
AU - Kalra, Philip
PY - 2020/8/27
Y1 - 2020/8/27
N2 - 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.
AB - 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.
U2 - 10.1371/journal.pone.0237467
DO - 10.1371/journal.pone.0237467
M3 - Article
SN - 1932-6203
VL - 15
JO - PLoS One.
JF - PLoS One.
ER -