title: Effect of patiromer on reducing serum potassium and preventing recurrent hyperkalaemia in patients with heart failure and chronic kidney disease on RAAS inhibitors.
abstract: OBJECTIVE
  We evaluated the effects of patiromer, a potassium (K(+))-binding polymer, in a pre-specified analysis of hyperkalaemic patients with heart failure (HF) in the OPAL-HK trial.
  
  
  RESULTS
  Chronic kidney disease (CKD) patients on renin-angiotensin-aldosterone system inhibitors (RAASi) with serum K(+) levels ≥5.1 mEq/L to <6.5 mEq/L (n = 243) received patiromer (4.2 g or 8.4 g BID initially) for 4 weeks (initial treatment phase); the primary efficacy endpoint was mean change in serum K(+) from baseline to week 4. Eligible patients (those with baseline K(+) ≥5.5 mEq/L to <6.5 mEq/L and levels ≥3.8 mEq/L to <5.1 mEq/L at the end of week 4) entered an 8-week randomized withdrawal phase and were randomly assigned to continue patiromer or switch to placebo; the primary efficacy endpoint was the between-group difference in median change in the serum K(+) over the first 4 weeks of that phase. One hundred and two patients (42%) had heart failure (HF). The mean [± standard error (SE)] change in serum K(+) from baseline to week 4 was -1.06 ± 0.05 mEq/L [95% confidence interval (CI), -1.16,-0.95; P < 0.001]; 76% (95% CI, 69,84) achieved serum K(+), 3.8 mEq/L to <5.1 mEq/L. In the randomized withdrawal phase, the median increase in serum K(+) from baseline of that phase was greater with placebo (n = 22) than patiromer (n = 27) (P < 0.001); recurrent hyperkalaemia (serum K(+), ≥5.5 mEq/L) occurred in 52% on placebo and 8% on patiromer (P < 0.001). Mild-to-moderate constipation was the most common adverse event (11%); hypokalaemia occurred in 3%.
  
  
  CONCLUSIONS
  In patients with CKD and HF who were hyperkalaemic on RAASi, patiromer was well tolerated, decreased serum K(+), and, compared with placebo, reduced recurrent hyperkalaemia.
authors.affiliation: Department of Medicine, University of Michigan School of Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109-0366, USA.
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: ASH Comprehensive Hypertension Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, The University of Chicago Medicine, Chicago, IL, USA.
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.affiliation: University of Rochester School of Medicine, Rochester, NY, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Bushinsky
authors.affiliation: Relypsa, Inc., Redwood City, CA, USA.
authors.forename: Dahlia
authors.initials: D
authors.lastname: Garza
authors.affiliation: Relypsa, Inc., Redwood City, CA, USA.
authors.forename: Martha R
authors.initials: MR
authors.lastname: Mayo
authors.affiliation: Relypsa, Inc., Redwood City, CA, USA.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Stasiv
authors.affiliation: Statistics Collaborative, Inc., Washington, DC, USA.
authors.forename: Heidi
authors.initials: H
authors.lastname: Christ-Schmidt
authors.affiliation: Relypsa, Inc., Redwood City, CA, USA.
authors.forename: Lance
authors.initials: L
authors.lastname: Berman
authors.affiliation: Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Weir
mesh_terms: D000368:Aged; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000627:therapeutic use; D005260:Female; D006333:Heart Failure / Q000097:blood / Q000150:complications*; D006801:Humans; D006947:Hyperkalemia / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use; D011108:Polymers / Q000627:therapeutic use*; D011188:Potassium / Q000097:blood*; D012008:Recurrence; D051436:Renal Insufficiency, Chronic / Q000097:blood* / Q000150:complications / Q000188:drug therapy*; D000092502:Renin Inhibitors
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D002317:Cardiovascular Agents; D000451:Mineralocorticoid Receptor Antagonists; D011108:Polymers; D011188:Potassium; D000092502:Renin Inhibitors; C568789:patiromer
keywords: chronic kidney disease; heart failure; hyperkalaemia; patiromer