Efficacy in patients across all settings

In adult patients with hyperkalemia who are not on dialysis,

LOKELMA led to a rapid reduction in serum K+ levels in as early as 1 hour1,2 and sustained normokalemia* for up to 1 year with continued treatment1

WORKS RAPIDLY

Works rapidly
Works rapidly

IN STUDY 1, within 1 hour after first dose of LOKELMA 10 g, reduction in K+ levels was observed in patients1,2

The study met its primary endpoint demonstrating a greater reduction in serum K+ levels over the 48-hour initial treatment period with LOKELMA 10 g tid compared to placebo (P<0.001)1,2

SUSTAINS K+

Sustains K+
Sustains K+

In STUDY 2 and STUDY 2 Extension, LOKELMA sustained normal serum K+ levels for up to 1 year with continued treatment1,3,4

STUDY 1: MEAN SERUM K+ IN THE INITIAL PHASE OVER 48 HOURS1,2

Efficacy Chart Study
Efficacy Chart Study

IN STUDY 2, 92% of the patients enrolled (n=258) achieved normal K+ levels within 48 hours from baseline1

  • Average serum K+ levels decreased from 5.6 mEq/L to 4.5 mEq/L (with LOKELMA 10 g tid for 48 hours)1
92% of patients
92% of patients

IN STUDY 2, 92% of the patients enrolled (n=258) achieved normal K+ levels within 48 hours from baseline1

  • Average serum K+ levels decreased from 5.6 mEq/L to 4.5 mEq/L (with LOKELMA 10 g tid for 48 hours)1

LIMITATION OF USE: LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.1

STUDY 1 DESIGN: In the initial phase of a multicenter, 2-part, double-blind, randomized, placebo-controlled, phase 3 trial, 753 patients received placebo or 1.25 g, 2.5 g, 5 g, or 10 g LOKELMA tid for the initial 48 hours.1,2

STUDY 2 DESIGN: After the open-label initial phase of a multicenter, 2-part, phase 3 trial, in which 258 patients received 10 g LOKELMA tid for 48 hours, patients who achieved a K+ level between 3.5 and 5.0 mEq/L were randomized to receive 5 g, 10 g, or 15 g LOKELMA or placebo once daily for 28 days in the maintenance phase. 123 patients who completed the maintenance phase participated in the 11-month, open-label extension study.1,3

tid=3 times a day.

IN STUDY 21,3:

  • LOKELMA-treated patients (n=258) with hyperkalemia who achieved normokalemia at 48 hours were included in the double-blind, randomized maintenance phase of the study1,3
  • Primary endpoint was met: mean serum K+ levels on Days 8-29 were lower with LOKELMA 5 g, 10 g, and 15 g vs placebo (4.8 mEq/L, 4.5 mEq/L, and 4.4 mEq/L vs 5.1 mEq/L, respectively; P≤0.001 for all doses)1,3

STUDY 2 EXTENSION: In patients who remained in the open-label extension phase, LOKELMA sustained normal serum K+ levels with continued treatment for 11 months1

MEAN SERUM K+ LEVELS IN PATIENTS WHO COMPLETED A 28-DAY RANDOMIZED MAINTENANCE PHASE AND CONTINUED ON LOKELMA FOR 11 MONTHS1

Main serum chart
Main serum chart

 

  • The mean dose of LOKELMA was 10 g qd in 73.2% (90/123) of patients; >10 g qd in 13.0% (16/123), and <10 g qd in 13.8% (17/123) of patients4

STUDY 2 EXTENSION DESIGN: Patients who were included in the 28-day randomized maintenance phase of Study 2 had the option to continue treatment with LOKELMA in an open-label extension phase for up to 11 months (N=123). The LOKELMA dose was titrated in 5-g increments (to 5 g qod up to 15 g qd) based on i-STAT K+ levels.1,4

*Normokalemia was defined as serum K+ levels between 3.5 mEq/L and 5.0 mEq/L.3,4

qd=once daily; qod=every other day; tid=3 times a day.

In adult patients with hyperkalemia who are on hemodialysis,

LOKELMA achieved and sustained lower pre-dialysis K+ levels vs placebo1,5

LOKELMA is the only FDA-approved K+ binder with efficacy and safety results in the label for adult patients with hyperkalemia on chronic hemodialysis1

STUDY 4:

  • 41% of patients treated with LOKELMA (n=97) achieved the primary endpoint compared to 1% of patients in the placebo group (n=99; P<0.001)1,5
  • Responders maintained pre-dialysis serum K+ between 4.0-5.0 mEq/L during at least 3 of 4 hemodialysis treatments after the LIDI and did not receive rescue therapy* during the evaluation period1,5

LOKELMA sustained lower pre-dialysis K+ levels in patients on hemodialysis with continued treatment1

MEAN PRE-DIALYSIS SERUM K+ LEVELS OVER TIME IN PATIENTS ON CHRONIC HEMODIALYSIS1

Mean pre-dialysis
Mean pre-dialysis

 

STUDY DESIGN 4: DIALIZE was a double-blind, placebo-controlled trial in patients with end-stage renal disease on chronic hemodialysis (≥3 months) and persistent hyperkalemia (n=196) who were randomized to receive LOKELMA 5 g or placebo once daily on non-dialysis days. In the initial 4-week period the dose could be adjusted weekly in 5-g increments up to 15 g qd on non-dialysis days to achieve pre-dialysis serum K+ levels between 4.0 mEq/L and 5.0 mEq/L after the LIDI. The dose at the end of the dose-adjustment period was maintained throughout the 4-week evaluation period. Baseline mean pre-dialysis serum K+ levels after the LIDI were 5.8 mEq/L in the LOKELMA group and 5.9 mEq/L in the placebo group.1,5

*Rescue therapy was defined as any urgent therapeutic intervention considered necessary to reduce serum K+ in the setting of severe hyperkalemia (defined by protocol as >6.0 mEq/L). Rescue therapy use was left to the investigator's clinical judgment to be given in accordance with local practice guidelines.5

Persistent hyperkalemia defined as pre-dialysis serum K+ >5.4 mEq/L after the LIDI and >5.0 mEq/L after at least one SIDI.5

LIDI=long interdialytic interval; SIDI=short interdialytic interval.

Review the safety profile for LOKELMA