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. 2016 Jan;41(1):43–50.

Table 3.

Pivotal Clinical Trials Evaluating Efficacy of Patiromer (Veltassa) in Patients With Hyperkalemia

Trial Design Primary Endpoint Results
Weir et al.48 (OPAL-HK)

  • Single-group, single-blind initial treatment phase in 219 patients with CKD and hyperkalemia receiving RAAS inhibitors; 107 patients entered placebo-controlled, single-blind, randomized withdrawal phase

  • Treatment: patiromer 4.2 g or 8.4 g BID in patients with mild or moderate hyperkalemia, respectively, for 4 weeks (initial phase); patients continued with patiromer (n = 55) or switched to placebo (n = 52) for additional 8 weeks (withdrawal phase)

 Between-group difference in median change in serum potassium level over first 4 weeks of withdrawal phase Estimated median change in potassium level to week 4 of withdrawal phase: 0 mmol/L for patiromer vs. 0.72 mmol/L for placebo (P < 0.001)
Pitt et al.49 (PEARL-HF)

  • Double-blind, randomized, placebo-controlled, parallel-group study in 105 patients with heart failure and history of hyperkalemia or CKD

  • Treatment: patiromer 15 g BID or placebo BID for 4 weeks

 Mean change in serum potassium from baseline to end of study (day 28) Significantly reduced mean serum potassium level with patiromer vs. placebo at end of treatment (between-group difference: −45 mEq/L [P < 0.001])
Bakris et al.54 (AMETHYST-DN)

  • Phase 2, open-label, dose-ranging, randomized study in outpatients with type-2 diabetes and mild (n = 222) or moderate (n = 84) hyperkalemia

  • Initial dosages: for mild hyperkalemia, patiromer 4.2 g (n = 74), 8.4 g (n = 74), or 12.6 g (n = 74) BID; for moderate hyperkalemia, patiromer 8.4 g (n = 26), 12.6 g (n = 28), or 16.8 g (n = 30) BID; all patients received RAAS inhibitors

 Mean change in serum potassium level from baseline to week 4 or before initiation of dose titration Mean reductions in serum potassium levels in patients with mild hyperkalemia: 4.2 g, 0.35 mEq/L; 8.4 g, 0.51 mEq/L; 12.6 g, 0.55 mEq/L
Mean reductions in serum potassium levels in patients with moderate hyperkalemia: 8.4 g, 0.87 mEq/L; 12.6 g, 0.97 mEq/L; 16.8 g, 0.92 mEq/L

BID = twice daily; CKD = chronic kidney disease; RAAS = renin–angiotensin–aldosterone system.