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
| Autor: | Bertram, Pitt, Stefan D, Anker, David A, Bushinsky, Dalane W, Kitzman, Faiez, Zannad, I-Zu, Huang, Suzette, Warren |
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| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty Hyperkalemia Polymers medicine.drug_class Adrenergic beta-Antagonists Placebo-controlled study Angiotensin-Converting Enzyme Inhibitors Spironolactone Placebo Gastroenterology Young Adult chemistry.chemical_compound Double-Blind Method Internal medicine Humans Medicine Potassium binder Prospective Studies Beta blocker Aged Mineralocorticoid Receptor Antagonists Heart Failure business.industry Patiromer Middle Aged Hypokalemia Surgery Treatment Outcome chemistry Chronic Disease Potassium Kidney Failure Chronic Female medicine.symptom Cardiology and Cardiovascular Medicine business |
| Zdroj: | European Heart Journal. 32:820-828 |
| ISSN: | 1522-9645 0195-668X |
| DOI: | 10.1093/eurheartj/ehq502 |
| Popis: | 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.One hundred and five patients with HF and a history of hyperkalaemia resulting in discontinuation of a renin-angiotensin-aldosterone system inhibitor/blocker and/or beta-adrenergic blocking agent or chronic kidney disease (CKD) with an estimated glomerular filtration rate of60 mL/min were randomized to double-blind treatment with 30 g/day RLY5016 or placebo for 4 weeks. Spironolactone, initiated at 25 mg/day, was increased to 50 mg/day on Day 15 if K+ 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 (P0.001); 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+3.5 mEq/L) occurred in 6% of RLY5016 patients vs. 0% of placebo patients (P= 0.094).RLY5016 prevented hyperkalaemia and was relatively well tolerated in patients with HF receiving standard therapy and spironolactone (25-50 mg/day). |
| Databáze: | OpenAIRE |
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