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The prescribing data for Lokelma® (sodium zirconium cyclosilicate; AstraZeneca) has been up to date to incorporate a dosing routine to deal with hyperkalemia in sufferers with end-stage renal illness (ESRD) on persistent hemodialysis.
Lokelma is a potassium binder indicated for the remedy of hyperkalemia in grownup sufferers. Beforehand, dosing was not established for sufferers with ESRD on persistent hemodialysis. The approval was based mostly on outcomes from the double-blind, placebo-controlled part 3b DIALIZE trial that evaluated the efficacy of Lokelma in 196 persistent hemodialysis sufferers with persistent pre-dialysis hyperkalemia (imply baseline potassium 5.8mEq/L).
Sufferers have been randomized to obtain Lokelma 5g initially or placebo as soon as each day on non-dialysis days; in the course of the dose adjustment interval (preliminary Four weeks), the dose was adjusted weekly in 5g increments as much as 15g as soon as each day based mostly on pre-dialysis serum potassium measurement after the lengthy inter-dialytic interval to realize a pre-dialysis serum potassium degree between 4.0-5.0mEq/L. The dose reached on the finish of the dose-adjustment interval was maintained all through the next 4-week analysis interval.
The first finish level was the proportion of responders, outlined as sufferers who maintained a pre-dialysis serum potassium between 4.Zero and 5.0mEq/L on at the least three out of Four dialysis therapies after the lengthy inter-dialytic interval and who didn’t obtain rescue remedy in the course of the analysis interval.
Outcomes confirmed that the Lokelma remedy arm had a considerably larger proportion of responders in contrast with placebo (41% vs 1%; P <.001). Moreover, 2.1% of sufferers handled with Lokelma wanted rescue remedy to cut back serum potassium for extreme hyperkalemia in the course of the remedy interval in contrast with 5.1% of the placebo arm.
The security profile of Lokelma was per that seen in earlier trials.
Lokelma is provided as 5g or 10g single-use packets of sodium zirconium cyclosilicate. Whereas the beneficial beginning dose for sufferers on persistent hemodialysis is 5g as soon as each day on non-dialysis days, a 10g dose could also be thought of in sufferers with serum potassium >6.5mEg/L.
For extra data go to astrazeneca-us.com.
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