Evidence map›Paper›PMID 26459796›Full record

ArticleEuropean journal of heart failure2015

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

Bertram Pitt, George L Bakris, David A Bushinsky, Dahlia Garza, Martha R Mayo, Yuri Stasiv, Heidi Christ-Schmidt, Lance Berman, Matthew R Weir

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in European journal of heart failure, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03740048 (A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis), which is not on this map. Cited by 69 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 8 pooled it
13.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03740048 phase3completednot on this mapstarted 2019, after this paper: background citation

A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)

TypeinterventionalSponsorWake Forest University Health SciencesRan2019 to 2021Enrolled51ConditionsEnd Stage Renal Failure on DialysisArmsHemodialysis, Patiromer Oral Product
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 8 syntheses or guidelines pooled it, 158 citations in OpenAlex.

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  12. Evaluation of the Potential for Drug Interactions With Patiromer in Healthy Volunteers.Journal of cardiovascular pharmacology and therapeutics · 2017
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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Bertram PittDepartment of Medicine, University of Michigan School of Medicine, 1500 East Medical Center Drive, Ann Arbor, MI, 48109-0366, USA.
George L BakrisASH Comprehensive Hypertension Center, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, The University of Chicago Medicine, Chicago, IL, USA.
David A BushinskyUniversity of Rochester School of Medicine, Rochester, NY, USA.
Dahlia GarzaRelypsa, Inc., Redwood City, CA, USA.
Martha R MayoRelypsa, Inc., Redwood City, CA, USA.
Yuri StasivRelypsa, Inc., Redwood City, CA, USA.
Heidi Christ-SchmidtStatistics Collaborative, Inc., Washington, DC, USA.
Lance BermanRelypsa, Inc., Redwood City, CA, USA.
Matthew R WeirDivision of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Electronic Arts (United States) · USMichigan Medicine · USStatistics Collaborative · USUniversity of Chicago · USUniversity of Maryland, Baltimore · USUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe 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

resultsChronic 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%.

conclusionIn patients with CKD and HF who were hyperkalaemic on RAASi, patiromer was well tolerated, decreased serum K(+), and, compared with placebo, reduced recurrent hyperkalaemia.

Indexed as

AgedAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsCardiovascular AgentsFemaleHeart FailureHumansHyperkalemiaMaleMiddle AgedMineralocorticoid Receptor AntagonistsPolymersPotassiumRecurrenceRenal Insufficiency, ChronicRenin InhibitorsAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsCardiovascular AgentsMineralocorticoid Receptor AntagonistspatiromerPolymersPotassiumRenin Inhibitorschronic kidney diseaseheart failurehyperkalaemiapatiromer

Identifiers

PMID26459796
PMCPMC5057342
OpenAlexW2163340573

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.