PMID- 34018121
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210803
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 8
IP  - 3
DP  - 2021 Sep
TI  - 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.
PG  - 315-323
LID - 10.1007/s40801-021-00254-7 [doi]
AB  - INTRODUCTION: The availability of the sodium-free potassium binder patiromer 
      opens new opportunities for hyperkalemia management. OBJECTIVE: Our 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. METHODS: Postmarketing safety 
      data regarding patiromer (Veltassa((R)); Vifor Pharma, Inc.), collected and 
      recorded in the company's global pharmacovigilance database, were analyzed for 
      the period from January 2016 through September 2019. These data were both 
      solicited (i.e., via an organized data-collection method such as a 
      patient-support program) and unsolicited (i.e., voluntarily reported by 
      healthcare professionals, consumers, and competent authorities worldwide). The 
      cumulative annualized mortality rate (events per 100 patient-years [PYs]) for the 
      pharmacovigilance database analysis period were compared with the rate obtained 
      in the longest patiromer clinical trial to date (up to 52 weeks of treatment). 
      For individual AEs, reporting rates (% of events/100 PYs) for events collected in 
      the global pharmacovigilance database were compared with the frequencies (% of 
      patients with event/patients exposed) of events collected in the clinical trial 
      program (N = 666). RESULTS: Over 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. CONCLUSIONS: Global 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.
CI  - (c) 2021. The Author(s).
FAU - Rossignol, Patrick
AU  - Rossignol P
AD  - University of Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116, Nancy, 
      France. p.rossignol@chru-nancy.fr.
AD  - F-CRIN INI-CRCT, Nancy, France. p.rossignol@chru-nancy.fr.
FAU - David, Lea
AU  - David L
AD  - Vifor Pharma, Inc., Redwood City, CA, USA.
FAU - Chan, Christine
AU  - Chan C
AD  - Vifor Pharma, Inc., Redwood City, CA, USA.
FAU - Conrad, Ansgar
AU  - Conrad A
AD  - Vifor Pharma, Inc., Redwood City, CA, USA.
FAU - Weir, Matthew R
AU  - Weir MR
AD  - University of Maryland School of Medicine, Baltimore, MD, USA.
LA  - eng
PT  - Journal Article
DEP - 20210520
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC8324724
COIS- Patrick Rossignol has consulted for Bayer, G3P, Idorsia, and KBP; has received 
      honoraria from Ablative Solutions, AstraZeneca, Bayer, Boehringer Ingelheim, 
      Corvidia, CVRx, Fresenius, Grunenthal, Novartis, Novo Nordisk, Vifor Pharma, 
      Inc., Sanofi, Sequana Medical, Servier, Stealth Peptides, and Vifor Fresenius 
      Medical Care Renal Pharma; and is a cofounder of CardioRenal. Lea David, 
      Christine Chan, and Ansgar Conrad are employed by and own stock in Vifor Pharma, 
      Inc. Matthew R. Weir has consulted for and received honoraria for scientific 
      advisory boards from Vifor Pharma, Inc., Vifor Pharma Management Ltd., 
      AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, MSD, and Novo Nordisk.
EDAT- 2021/05/22 06:00
MHDA- 2021/05/22 06:01
PMCR- 2021/05/20
CRDT- 2021/05/21 06:42
PHST- 2021/04/22 00:00 [accepted]
PHST- 2021/05/22 06:00 [pubmed]
PHST- 2021/05/22 06:01 [medline]
PHST- 2021/05/21 06:42 [entrez]
PHST- 2021/05/20 00:00 [pmc-release]
AID - 10.1007/s40801-021-00254-7 [pii]
AID - 254 [pii]
AID - 10.1007/s40801-021-00254-7 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2021 Sep;8(3):315-323. doi: 
      10.1007/s40801-021-00254-7. Epub 2021 May 20.