In a retrospective analysis of STUDY 3,

A majority of patients continued their RAAS inhibitor use*1

89% of patients continued RAAS inhibitor use while taking LOKELMA†1

89% of patients continued RAAS inhibitors
89% of patients continued RAAS inhibitors

Among patients on RAAS inhibitor therapy (n=520) during the maintenance phase of Study 3, a 12-month, open-label study evaluating LOKELMA in patients not on dialysis with hyperkalemia, 37 initiated therapy during the maintenance phase and 483 were on therapy at baseline. Of those 483 patients1:

  • 74% of patients had no change in RAAS inhibitor therapy1
  • 13% of patients had an increase in their RAAS inhibitor dose§1
  • 14% of patients had a decrease in their RAAS inhibitor dose§1

Of the 263 patients who were RAAS inhibitor naive at baseline, 14% initiated RAAS inhibitor treatment during the study.1

Over 3 to 12 months
Over 3 to 12 months

IN STUDY 3:

Over Months 3-12, mean serum K+ ≤5.1 mEq/L was achieved by 88% of patients.1

The treatment effect of LOKELMA was maintained with ongoing treatment regardless of RAAS inhibitor therapy1

STUDY 3 DESIGN: LOKELMA was evaluated for long-term efficacy in 751 patients with hyperkalemia in an open-label, single-arm, 12-month, phase 3 study. Following the initial-phase treatment of LOKELMA 10 g tid, patients who achieved normokalemiaII within 72 hours (n=746; 99%) entered the maintenance phase. For maintenance treatment, the initial dose of LOKELMA was 5 g qd and was adjusted to a minimum of 5 g qod up to a maximum of 15 g qd, based on i-STAT K+ level. The primary endpoints included the percentage of patients who achieved normokalemia,II based on serum K+ levels, during the initial phase and the percentage of patients who maintained mean serum K+ ≤5.1 mEq/L during Months 3-12 of the maintenance phase.1,2

*Based on a retrospective analysis of the changes in RAAS inhibitor use during the maintenance phase of a 12-month, open-label study.1

11% of patients receiving RAAS inhibitor therapy at baseline (n=483) discontinued RAAS inhibitors during the 12-month open-label trial.1

Excluded 5 patients who discontinued RAAS inhibitor therapy prior to their first dose of the study drug.1

§Patients were counted more than once if they required more than 1 RAAS inhibitor adjustment, so the total percentage across all 4 categories may exceed 100%.1

IINormokalemia was defined as K+ levels between 3.5 mEq/L and 5.0 mEq/L.2

qd=once daily; qod=every other day; RAAS=renin-angiotensin-aldosterone system; tid=3 times a day.

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