Format

Send to

Choose Destination
Eur J Heart Fail. 2015 Oct;17(10):1057-65. doi: 10.1002/ejhf.402. Epub 2015 Oct 12.

Effect of patiromer on reducing serum potassium and preventing recurrent hyperkalaemia in patients with heart failure and chronic kidney disease on RAAS inhibitors.

Author information

1
Department of Medicine, University of Michigan School of Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109-0366, USA.
2
ASH Comprehensive Hypertension Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, The University of Chicago Medicine, Chicago, IL, USA.
3
University of Rochester School of Medicine, Rochester, NY, USA.
4
Relypsa, Inc., Redwood City, CA, USA.
5
Statistics Collaborative, Inc., Washington, DC, USA.
6
Division of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.

Abstract

AIMS:

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.

METHODS AND 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%.

CONCLUSION:

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.

KEYWORDS:

chronic kidney disease; heart failure; hyperkalaemia; patiromer

PMID:
26459796
PMCID:
PMC5057342
DOI:
10.1002/ejhf.402
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center