Evidence map›Paper›PMID 29767459›Full record

Trial reportESC heart failure2018

Long-term effects of patiromer for hyperkalaemia treatment in patients with mild heart failure and diabetic nephropathy on angiotensin-converting enzymes/angiotensin receptor blockers: results from AMETHYST-DN.

Bertram Pitt, George L Bakris, Matthew R Weir, Mason W Freeman, Mitja Lainscak, Martha R Mayo, Dahlia Garza, Rezi Zawadzki, Lance Berman, David A Bushinsky

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESC heart failure, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Article
  10. Management of hyperkalemia: Expert consensus from Kuwait - a Modified Delphi Approach.International journal of nephrology and renovascular disease · 2024
    Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Observational
  17. Review
  18. Article
  19. Review
  20. Mitigating risk of aldosterone in diabetic kidney disease.Current opinion in nephrology and hypertension · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 2 countries.

Bertram PittDepartment of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.
George L BakrisDepartment of Medicine, University of Chicago Medicine, Chicago, IL, USA.
Matthew R WeirDivision of Nephrology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Mason W FreemanDepartment of Medicine, Massachusetts General Hospital, Harvard University, Boston, MA, USA.
Mitja LainscakDivision of Cardiology, General Hospital Murska Sobota, Murska Sobota, Slovenia.
Martha R MayoRelypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.
Dahlia GarzaRelypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.
Rezi ZawadzkiRelypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.
Lance BermanRelypsa, Inc., a Vifor Pharma Group Company, Redwood City, CA, USA.
David A BushinskyDivision of Nephrology, Department of Medicine, University of Rochester School of Medicine, Rochester, NY, USA.
Vifor Pharma (United States) · USHarvard University · USPomurski muzej Murska Sobota · SIUniversity of Chicago · USUniversity of Maryland, Baltimore · USUniversity of Michigan · USUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsChronic kidney disease (CKD) in heart failure (HF) increases the risk of hyperkalaemia (HK), limiting angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) use. Patiromer is a sodium-free, non-absorbed potassium binder approved for HK treatment. We retrospectively evaluated patiromer's long-term safety and efficacy in HF patients from AMETHYST-DN. METHODS AND

resultsPatients with Type 2 diabetes, CKD, and HK [baseline serum potassium >5.0-5.5 mmol/L (mild) or >5.5-<6.0 mmol/L (moderate)], with or without HF (New York Heart Association Class I and II, by investigator judgement), on ACE-I/ARB, were randomized to patiromer 8.4-33.6 g to start, divided twice daily. Overall, 105/304 (35%) patients had HF (75%, Class II). Mean (standard deviation) ejection fraction (EF) was 44.9% (8.2) (n = 81) in patients with HF; 26 had EF ≤40%. In HF patients, mean serum potassium decreased by Day 3 through Week 52. At Week 4, estimated mean (95% confidence interval) change in serum potassium was -0.64 mmol/L (-0.72, -0.55) in mild and -0.97 mmol/L (-1.14, -0.80) in moderate HK (both P < 0.0001). Most HF patients with mild (>88%) and moderate (≥73%) HK had normokalaemia at each visit from Weeks 12 to 52. Three HF patients were withdrawn because of high (n = 1) or low (n = 2) serum potassium. The most common patiromer-related adverse event was hypomagnesaemia (8.6%).

conclusionsIn patients with a clinical diagnosis of HF, diabetes, CKD, and HK on ACE-I/ARB, patiromer was well tolerated and effective for HK treatment over 52 weeks.

Indexed as

Angiotensin-Converting Enzyme InhibitorsDiabetic NephropathiesHeart FailureHyperkalemiaLosartanPotassiumStroke VolumeAngiotensin II Type 1 Receptor BlockersBiomarkersDose-Response Relationship, DrugDrug Therapy, CombinationFollow-Up StudiesHumansRetrospective StudiesSpironolactoneTime FactorsAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersBiomarkersLosartanPotassiumSpironolactoneHeart failureHyperkalaemiaPatiromerRAASi

Identifiers

PMID29767459
PMCPMC6073017
OpenAlexW2803591266

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.