Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial

Bertram Pitt, Stefan D. Anker, David A. Bushinsky, Dalane W. Kitzman, Faiez Zannad, I. Zu Huang

Research output: Contribution to journalArticle

Abstract

Aims To evaluate efficacy and safety of RLY5016 (a non-absorbed, orally administered, potassium [K +]-binding polymer) on serum K + levels in patients with chronic heart failure (HF) receiving standard therapy and spironolactone. Methods and resultsOne hundred and five patients with HF and a history of hyperkalaemia resulting in discontinuation of a reninangiotensinaldosterone system inhibitor/blocker and/or beta-adrenergic blocking agent or chronic kidney disease (CKD) with an estimated glomerular filtration rate of + was ≤5.1 mEq/L. Endpoints included the change from baseline in serum K + at the end of treatment (primary); the proportion of patients with hyperkalaemia (K + >5.5 mEq/L); and the proportion titrated to spironolactone 50 mg/day. Safety assessments included adverse events (AEs) and clinical laboratory tests. RLY5016 (n 55) and placebo (n 49) patients had similar baseline characteristics. At the end of treatment, compared with placebo, RLY5016 had significantly lowered serum K + levels with a difference between groups of -0.45 mEq/L (P <0.001); a lower incidence of hyperkalaemia (7.3 RLY5016 vs. 24.5 placebo, P 0.015); and a higher proportion of patients on spironolactone 50 mg/day (91 RLY5016 vs. 74 placebo, P 0.019). In patients with CKD (n 66), the difference in K + between groups was -0.52 mEq/L (P 0.031), and the incidence of hyperkalaemia was 6.7 RLY5016 vs. 38.5 placebo (P 0.041). Adverse events were mainly gastrointestinal, and mild or moderate in severity. Adverse events resulting in study withdrawal were similar (7 RLY5016, 6 placebo). There were no drug-related serious AEs. Hypokalaemia (K +

Original languageEnglish
Pages (from-to)820-828
Number of pages9
JournalEuropean Heart Journal
Volume32
Issue number7
DOIs
Publication statusPublished - Apr 2011

Keywords

  • Aldosterone antagonist
  • Chronic kidney disease
  • Heart failure
  • Hyperkalaemia
  • Potassium-binding polymer
  • RLY5016

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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