Prospective and Real-world, Retrospective Studies

VELTASSA was shown to be safe and effective in 27 anuric patients on dialysis¹

• Mean serum K⁺ was reduced from 5.7 mEq/L in pre-treatment to 5.1 mEq/L during treatment, then increased to 5.4 mEq/L post-treatment
• 58% of patients on VELTASSA had mean serum K⁺ > 5.0 mEq/L during the treatment phase and none had mean serum K⁺ < 3.5 mEq/L

Study design

A 20-week prospective study of anuric patients on hemodialysis (N=27). Serum K⁺ was measured during 2 consecutive weeks of no treatment, for 12 weeks of treatment with VELTASSA 16.8 g once daily, and for 6 weeks of no treatment. Primary objective was to determine the safety and efficacy of VELTASSA in reducing serum K⁺. Of the patients studied, the mean age was 57 years, 52% were female, 74% were African American, and 41% had diabetes.

Mean serum K⁺ results in a retrospective EHR analysis >500 ESRD patients on dialysis²

• Approximately 75% of patients had a baseline K⁺ of ≥ 5.5 mEq/L
• 61% (n=322) started and remained on VELTASSA 8.4 g once daily
• 75% of patients remained on VELTASSA for at least 80% of the study period
• Safety was not evaluated in this retrospective analysis

Dialysis retrospective study design

Treatment of hyperkalemia in hemodialysis patients who newly initiated VELTASSA in real-world practice

In a retrospective observational study using Electronic Health Record (EHR) data (N=527), patients (≥ 18 years) receiving hemodialysis at a large U.S. dialysis provider between December 21, 2015, and December 20, 2016, were identified. K⁺ values were summarized in 6 sequential 30-day periods, 3 preceding and 3 following VELTASSA initiation. Patients had at least 24 hemodialysis treatments in the 3 months prior to VELTASSA initiation. Of 527 patients studied, the mean age was 59 years, 57% were men, 70% were white/Hispanic, and 17% were black.

Significant serum K⁺ reduction was observed with VELTASSA in a real-world analysis of > 450 ESRD patients on dialysis³

• The most common (69%; n=675) medication schedule dispensed was VELTASSA 8.4 g once daily 
• 78% (n=356) of patients received only one treatment course of VELTASSA
• Safety was not evaluated in this observational study

Study design

• Real-world, observational study: Electronic health record data of US veterans with ESRD (N=458) who were dispensed outpatient VELTASSA in the Veterans Health Administration (VHA) from January 2016 through February 2021
• Objective: Evaluate real-world utilization of VELTASSA in an ESRD population and its corresponding association with serum K⁺ changes
• Study population: Patients 18 years or older with an International Classification of Diseases (ICD) diagnostic code entry for ESRD within 365 days pre-index from either an outpatient or an inpatient visit in VHA. Baseline serum K⁺ was ≥ 5.1 mEq/L and was determined using the laboratory event closest to the index date, within 91 days pre-index
• Primary analysis: Change between mean K⁺ closest to the VELTASSA index compared to mean K⁺ values closest to the end of the follow-up intervals
• Limitations: This study was descriptive and not designed to isolate the impact of VELTASSA on average serum K⁺ during the follow-up intervals. Additionally, there was no control between the timing of dialysis and K⁺ measurements. It is also possible that changes in serum K⁺ were due to a result of other influences