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

Abstract

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 ® ; 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.

Experience with the potassium binder patiromer in hyperkalaemia management in heart failure patients in real life

“… 25 This report's most common non‐serious AE were gastrointestinal disturbances (18% in clinical programme and 15% in pharmacovigilance data), similar to our cohort (14.9%). Like other studies, most AE were mild 25 and was detected in the first month of patiromer treatment. 23 …”

Assessment of Patiromer Monotherapy for Hyperkalemia in an Acute Care Setting

“…Of interest, recently published rates of decreased potassium and magnesium levels from a 4-year global pharmacovigilance database of adverse drug events in patients who were prescribed patiromer in clinical practice were 0.45% and 0.16%, respectively. 22 The variance in these rates across trial data, ambulatory surveillance, and institutional settings likely reflects different hyperkalemia causes, patient populations, and monitoring patterns.…”

Hyperkalaemia and potassium binders: Retrospective observational analysis looking at the efficacy and cost effectiveness of calcium polystyrene sulfonate and sodium zirconium cyclosilicate

“…12 Due to relatively slower onset of action compared to SZC its utility in acute settings might be limited. Common side effects include abdominal pain, constipation (incidence 6.90%), 15 diarrhoea (incidence 3.48%), 15 flatulence and hypomagnesaemia. 11 Patiromer also has the potential to bind to some co-administered drugs; therefore, it cannot be taken within 3 h of other medications.…”