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The prescribing information for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been updated to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease (ESRD) on chronic hemodialysis.
Lokelma is a potassium binder indicated for the treatment of hyperkalemia in adult patients. Previously, dosing was not established for patients with ESRD on chronic hemodialysis. The approval was based on results from the double-blind, placebo-controlled phase 3b DIALIZE trial that evaluated the efficacy of Lokelma in 196 chronic hemodialysis patients with persistent pre-dialysis hyperkalemia (mean baseline potassium 5.8mEq/L).
Patients were randomized to receive Lokelma 5g initially or placebo once daily on non-dialysis days; during the dose adjustment period (initial 4 weeks), the dose was adjusted weekly in 5g increments up to 15g once daily based on pre-dialysis serum potassium measurement after the long inter-dialytic interval to achieve a pre-dialysis serum potassium level between 4.0-5.0mEq/L. The dose reached at the end of the dose-adjustment period was maintained throughout the subsequent 4-week evaluation period.
The primary end point was the proportion of responders, defined as patients who maintained a pre-dialysis serum potassium between 4.0 and 5.0mEq/L on at least 3 out of 4 dialysis treatments after the long inter-dialytic interval and who did not receive rescue therapy during the evaluation period.
Results showed that the Lokelma treatment arm had a significantly greater proportion of responders compared with placebo (41% vs 1%; P <.001). Additionally, 2.1% of patients treated with Lokelma needed rescue therapy to reduce serum potassium for severe hyperkalemia during the treatment period compared with 5.1% of the placebo arm.
The safety profile of Lokelma was consistent with that seen in previous trials.
Lokelma is supplied as 5g or 10g single-use packets of sodium zirconium cyclosilicate. While the recommended starting dose for patients on chronic hemodialysis is 5g once daily on non-dialysis days, a 10g dose may be considered in patients with serum potassium >6.5mEg/L.
For more information visit astrazeneca-us.com.
