PMID- 33007353
OWN - NLM
STAT- MEDLINE
DCOM- 20201221
LR  - 20210923
IS  - 1873-1740 (Electronic)
IS  - 0033-0620 (Linking)
VI  - 63
IP  - 5
DP  - 2020 Sep-Oct
TI  - Effect of patiromer on serum potassium in hyperkalemic patients with heart 
      failure: Pooled analysis of 3 randomized trials.
PG  - 656-661
LID - S0033-0620(20)30163-8 [pii]
LID - 10.1016/j.pcad.2020.09.007 [doi]
AB  - BACKGROUND: Hyperkalemia (HK) is a serious medical condition that can cause 
      potentially fatal cardiac arrhythmias. Patients with heart failure (HF) are at 
      risk of HK due to underlying chronic kidney disease and use of 
      guideline-recommended renin-angiotensin-aldosterone system inhibitors. Patiromer, 
      a sodium-free, non-absorbed potassium (K(+)) binder, is indicated for the 
      treatment of HK. OBJECTIVE: To evaluate the consistency of patiromer's effect on 
      lowering serum K(+) in patients with HF and HK using pooled data from three 
      clinical trials. METHODS: This post-hoc analysis evaluated the efficacy and 
      safety of patiromer for management of HK over a 4-week treatment period using 
      combined data from three clinical trials (AMETHYST-DN, OPAL-HK and TOURMALINE). 
      Eligible patients had HK (serum K(+) > 5.0 mEq/L) at study entry. Starting doses 
      of patiromer ranged from 8.4 to 33.6 g/day. In this analysis, efficacy was 
      assessed as the mean (+/- standard error [SE]) change in serum K(+) from baseline 
      to Week 4. Safety outcomes evaluated included the incidence and severity of 
      adverse events (AEs) during the 4-week treatment period. RESULTS: In total, 653 
      patients who received >/=1 dose of patiromer were evaluable for efficacy (214 
      diagnosed with HF and 439 without HF). Mean baseline serum K(+) was 5.4 mEq/L. 
      Patient characteristics were generally similar between the HF and non-HF 
      subgroups. Serum K(+) decreased to <5.0mEq/L within one week of patients starting 
      patiromer, reaching a nadir after 3 weeks in both the HF and non-HF subgroups 
      (4.59 mEq/L and 4.64 mEq/L, respectively). The mean +/- SE change from baseline to 
      Week 4 in serum K(+) was -0.79 +/- 0.06 mEq/L (95% CI: -0.91, -0.68) in patients 
      with HF and - 0.75 +/- 0.02 mEq/L (95% CI: -0.79, -0.70) in patients without HF. 
      AEs occurred in 31% of patients with HF and 37% of patients without HF and were 
      mostly mild or moderate in severity. The most common AEs were constipation (HF 
      patients: 7%, non-HF patients: 5%) and diarrhea (HF patients: 2%, non-HF 
      patients: 4%). AEs leading to discontinuation of patiromer occurred in 7% of 
      patients with HF and in 3% of patients without HF. CONCLUSIONS: In this pooled 
      analysis of patients with HK, patiromer was generally well tolerated and reduced 
      serum K(+) similarly in patients with and without HF over 4 weeks.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Pina, Ileana L
AU  - Pina IL
AD  - Wayne State University, Detroit, MI, USA. Electronic address: ilppina@aol.com.
FAU - Yuan, Jinwei
AU  - Yuan J
AD  - Relypsa, Inc., a Vifor Pharma Company, Redwood City, CA, USA.
FAU - Ackourey, Gail
AU  - Ackourey G
AD  - Relypsa, Inc., a Vifor Pharma Company, Redwood City, CA, USA.
FAU - Ventura, Hector
AU  - Ventura H
AD  - Department of Cardiology, Cardiomyopathy and Heart Transplantation Center, 
      Ochsner Clinic Foundation, New Orleans, LA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200930
PL  - United States
TA  - Prog Cardiovasc Dis
JT  - Progress in cardiovascular diseases
JID - 0376442
RN  - 0 (Biomarkers)
RN  - 0 (Chelating Agents)
RN  - 0 (Polymers)
RN  - 1FQ2RY5YHH (patiromer)
RN  - RWP5GA015D (Potassium)
SB  - IM
CIN - Prog Cardiovasc Dis. 2021 Jul-Aug;67:114-115. PMID: 34412825
MH  - Aged
MH  - Aged, 80 and over
MH  - Biomarkers/blood
MH  - Chelating Agents/adverse effects/*therapeutic use
MH  - Down-Regulation
MH  - Female
MH  - Heart Failure/diagnosis/*drug therapy/epidemiology/physiopathology
MH  - Humans
MH  - Hyperkalemia/blood/diagnosis/*drug therapy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Polymers/adverse effects/*therapeutic use
MH  - Potassium/*blood
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Heart failure
OT  - Hyperkalemia
OT  - Patiromer
OT  - Potassium binder
OT  - RAAS inhibitor
COIS- Declaration of Competing Interest ILP is a consultant for the U.S. Food and Drug 
      Administration/Center for Devices and Radiological Health; and serves on an 
      advisory board for Relypsa, Inc., a Vifor Pharma Company. JY and GA are employees 
      of Relypsa, Inc., a Vifor Pharma Company. HV has nothing to disclose.
EDAT- 2020/10/03 06:00
MHDA- 2020/12/22 06:00
CRDT- 2020/10/02 20:09
PHST- 2020/09/27 00:00 [received]
PHST- 2020/09/27 00:00 [accepted]
PHST- 2020/10/03 06:00 [pubmed]
PHST- 2020/12/22 06:00 [medline]
PHST- 2020/10/02 20:09 [entrez]
AID - S0033-0620(20)30163-8 [pii]
AID - 10.1016/j.pcad.2020.09.007 [doi]
PST - ppublish
SO  - Prog Cardiovasc Dis. 2020 Sep-Oct;63(5):656-661. doi: 10.1016/j.pcad.2020.09.007. 
      Epub 2020 Sep 30.