PMID- 29017162
OWN - NLM
STAT- MEDLINE
DCOM- 20180614
LR  - 20231112
IS  - 1421-9670 (Electronic)
IS  - 0250-8095 (Print)
IS  - 0250-8095 (Linking)
VI  - 46
IP  - 4
DP  - 2017
TI  - Patiromer Lowers Serum Potassium When Taken without Food: Comparison to Dosing 
      with Food from an Open-Label, Randomized, Parallel Group Hyperkalemia Study.
PG  - 323-332
LID - 10.1159/000481270 [doi]
AB  - BACKGROUND: Patiromer is a sodium-free, nonabsorbed, potassium binder approved 
      for treatment of hyperkalemia. This open-label study compares the efficacy and 
      safety of patiromer administered without food versus with food. METHODS: Adults 
      with hyperkalemia (potassium >/=5.0 mEq/L) were randomized (1:1) to receive 
      patiromer once daily without food or with food for 4 weeks. The dosage was 
      adjusted (maximum: 25.2 g/day) using a prespecified titration schedule to achieve 
      and maintain potassium within a target range (3.8-5.0 mEq/L). The primary 
      efficacy endpoint was the proportion of patients with serum potassium in the 
      target range at either week 3 or week 4. Safety was assessed by adverse events 
      (AEs) and laboratory testing. RESULTS: Efficacy was evaluated in 112 patients; 
      65.2% were >/=65 years of age, 75.9% had chronic kidney disease, and 82.1% had 
      diabetes. Baseline mean serum potassium was similar in the without-food (5.44 
      mEq/L) and with-food (5.34 mEq/L) groups. The primary endpoint was achieved by 
      87.3% (95% CI 75.5-94.7) and 82.5% (95% CI 70.1-91.3) of patients in the 
      with-food and without-food groups, respectively; least squares mean changes in 
      serum potassium from baseline to week 4 were -0.65 and -0.62 mEq/L, respectively 
      (p < 0.0001). The most common AEs were diarrhea and constipation. Serum K+ 
      remained >/=3.5 mEq/L in all patients; 5 patients developed serum magnesium <1.4 
      mg/dL, including 4 whose baseline magnesium was below the lower limit of normal. 
      CONCLUSION: Patiromer is equally effective and well tolerated when taken without 
      food or with food, thereby offering the potential for dosing flexibility.
CI  - (c) 2017 The Author(s) Published by S. Karger AG, Basel.
FAU - Pergola, Pablo E
AU  - Pergola PE
AD  - Renal Associates, P.A., San Antonio, TX, USA.
FAU - Spiegel, David M
AU  - Spiegel DM
FAU - Warren, Suzette
AU  - Warren S
FAU - Yuan, Jinwei
AU  - Yuan J
FAU - Weir, Matthew R
AU  - Weir MR
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
DEP - 20171011
PL  - Switzerland
TA  - Am J Nephrol
JT  - American journal of nephrology
JID - 8109361
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 0 (Chelating Agents)
RN  - 0 (Polymers)
RN  - 1FQ2RY5YHH (patiromer)
RN  - I38ZP9992A (Magnesium)
RN  - RWP5GA015D (Potassium)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiotensin-Converting Enzyme Inhibitors/adverse effects
MH  - Chelating Agents/*pharmacology/therapeutic use
MH  - Constipation/chemically induced/epidemiology
MH  - Diarrhea/chemically induced/epidemiology
MH  - Female
MH  - *Food-Drug Interactions
MH  - Humans
MH  - Hyperkalemia/blood/*drug therapy/etiology
MH  - Magnesium/blood
MH  - Male
MH  - Middle Aged
MH  - Polymers/*pharmacology/therapeutic use
MH  - Potassium/*blood
MH  - Random Allocation
MH  - Renal Insufficiency, Chronic/blood/complications/*drug therapy
MH  - Treatment Outcome
PMC - PMC5804834
OTO - NOTNLM
OT  - Hyperkalemia
OT  - Patiromer
OT  - Potassium
EDAT- 2017/10/11 06:00
MHDA- 2018/06/15 06:00
PMCR- 2017/10/11
CRDT- 2017/10/11 06:00
PHST- 2017/08/04 00:00 [received]
PHST- 2017/08/30 00:00 [accepted]
PHST- 2017/10/11 06:00 [pubmed]
PHST- 2018/06/15 06:00 [medline]
PHST- 2017/10/11 06:00 [entrez]
PHST- 2017/10/11 00:00 [pmc-release]
AID - 000481270 [pii]
AID - ajn-0046-0323 [pii]
AID - 10.1159/000481270 [doi]
PST - ppublish
SO  - Am J Nephrol. 2017;46(4):323-332. doi: 10.1159/000481270. Epub 2017 Oct 11.