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. 2021 May 12;7:e10. doi: 10.15420/cfr.2020.29

Table 3: Studies that Evaluated Patiromer in Hyperkalaemia.

Trial Population Intervention Endpoints Results
OPAL-HK: phase III, single-blind RCT[55] 237 CKD patients on RAASi and K+ of 5.1–6.5 mmol/l

  • 57% diabetes

  • 42% HF

 Phase 1 (open label): 4-week treatment with 4.2 or 8.4 g of patiromer twice daily
Phase 2 (randomised withdrawal phase): normokalaemic patients randomised to:

  • 4.2 or 8.2 g of patiromer for 8 weeks

  • Placebo for 8 weeks

 Change in mean K+ levels in first 4 weeks of phase 1 and change in median K+ levels in the first 4 weeks of phase 2 Phase 1: mean change in K+ levels from baseline was –1.01 mmol/l
Phase 2: median change in the K+ from the start of the randomised withdrawal phase to week 4 of the phase was 0.72 mmol/l in the placebo group and 0 mmol/l in the patiromer group
At week 8, 60% of patients in the placebo group had recurrence of hyperkalaemia
(K+ >5.5 mmol/l) versus 15% in the treatment group
PEARL-HF: phase III, double-blind RCT[56] 105 HF patients on standard therapy and either CKD or prior hyperkalaemia requiring cessation of RAASi

  • Mean EF 40%

  • NYHA II–III

 Two randomised groups:

  • 15 g of patiromer twice daily for 4 weeks

  • Placebo for 4 weeks

 Both groups on spironolactone 25–50 mg/day Mean change in K+ levels at 4 weeks At 4 weeks, patiromer lowered K+ by 0.45 mmol/l compared with placebo
AMBER: phase II, double-blind RCT[57] 295 patients with CKD (eGFR 25–45 ml/min) and uncontrolled resistant hypertension

  • 50% diabetes

  • 45% HF

 Two randomised groups that received open-label spironolactone in addition to 8.2 g of patiromer or placebo Between-group difference at week 12 in patients on spironolactone At 12 weeks, 66% of patients in the placebo group and 86% of patients in the patiromer group remained on spironolactone (between-group difference of 19.5%)

CKD = chronic kidney disease; EF = ejection fraction; eGFR = estimated glomerular filtration rate; HF = heart failure; NYHA = New York Health Association; RAASi = renin–angiotensin–aldosterone system inhibitors; RCT = randomised controlled trial.