ArticleDrugs - real world outcomes2021
Safety and Tolerability of the Potassium Binder Patiromer From a Global Pharmacovigilance Database Collected Over 4 Years Compared with Data from the Clinical Trial Program.
Article in Drugs - real world outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Efficacy and Tolerability of Sodium Zirconium Cyclosilicate or Patiromer in Managing Hyperkalemia: A Systematic Review and Meta-Analysis.Kidney360 · 2026Pooled it
- Hyperkalemia management in heart failure and chronic kidney disease: a Spanish cost-effectiveness analysis of patiromer informed by the integrated DIAMOND trial and real-world evidence.BMC health services research · 2026Article
- Efficacy of Patiromer in Treatment of Long Inter-Dialytic Interval Hyperkalemia in Potassium-Rich Diet Populations Undergoing Intermittent Hemodialysis.International journal of nephrology and renovascular disease · 2026Article
- Prevalence, practice pattern, and mortality of hyperkalemia in Chinese patients undergoing hemodialysis in the visualize HD study.Scientific reports · 2025Observational
- Hyperkalemia management: a multidisciplinary expert panel's perspective on the role of new potassium binders.Heart failure reviews · 2025Review
- Adverse drug events associated with sodium zirconium cyclosilicate: A real-world pharmacovigilance study based on the FAERS database.PloS one · 2025Article
- Patiromer to Reduce Albuminuria Through Increased Renin Angiotensin Aldosterone System Inhibition in Patients With CKD-A Feasibility Trial.Kidney international reports · 2024Article
- Review
- Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K).BMC nephrology · 2023Observational
- Sodium polystyrene is unsafe and should not be prescribed for the treatment of hyperkalaemia:Clinical kidney journal · 2023Article
- Pharmacological strategies to manage hyperkalaemia: out with the old, in with the new? Not so fast….Clinical kidney journal · 2023Article
- Experience with the potassium binder patiromer in hyperkalaemia management in heart failure patients in real life.ESC heart failure · 2022Article
- Assessment of Patiromer Monotherapy for Hyperkalemia in an Acute Care Setting.JAMA network open · 2022Article
- Clinical Efficacy, Safety, Tolerability, and Real-World Data of Patiromer for the Treatment of Hyperkalemia.Drug, healthcare and patient safety · 2022Review
- The Role of Patiromer in Delaying the Onset of Renal Replacement Therapy in Patients with Advanced Renal Failure.Case reports in nephrology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe availability of the sodium-free potassium binder patiromer opens new opportunities for hyperkalemia management.
objectiveOur objective was to compare data from a 4-year global pharmacovigilance database of adverse events (AEs) reported in patients prescribed patiromer in clinical practice compared with data obtained from the clinical trial program.
methodsPostmarketing safety data regarding patiromer (Veltassa
resultsOver 4 years, the global pharmacovigilance database contained an estimated 45,000 PYs of exposure (17,823 individual case reports and 38,109 AEs), with most cases (95%) from the USA; > 85% of cases utilized 8.4 g/day. In total, 1214 deaths were reported, with a cumulative annualized mortality rate of 2.69/100 PYs (vs. 5.70 deaths/100 PYs in the 52-week clinical trial). Global pharmacovigilance reporting rates for the two most common AEs, constipation and diarrhea, were 6.90 and 3.48%, respectively. Respective frequencies were 7.2 and 4.8% in the clinical trial program. The pharmacovigilance reporting rate for AEs of decreased blood potassium was 0.45%; serum potassium < 3.5 mmol/L was reported in 4.7% of patients in the clinical trial program. For hypomagnesemia or decreased blood magnesium, reporting rates in the postmarketing setting were 0.02 and 0.16%, respectively, and they were observed in 5.3 and 0.8% of patients, respectively, in the clinical trial program.
conclusionsGlobal pharmacovigilance data over 4 years confirmed that the tolerability and safety of patiromer in clinical practice is predictable and consistent with clinical trial data, with no evidence of any new safety signals to date.
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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.