The Hk Challenge

Reliable K+ Control

Proven RAASi Enablement

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Reliable K+ Control

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PROTECTS REGARDLESS OF HK SEVERITY1

PROVEN ROUND THE CLOCK PROTECTION2

PROVIDES SUSTAINED LONG-TERM K+ CONTROL3

VELTASSA®

Veltassa® protects regardless of HK severity1

Hyperkalemia treatment aims to lower and maintain K+ levels, Veltassa® can do this regardless of hyperkalemia severity.1

Of 243 patients with CKD and hyperkalemia receiving RAASi therapy, 76% had serum K+ in the target range (3. 8–<5.1 mEq/L) at Week 4.1

Similar results in patients with:

  • Mild hyperkalemia (74% [95% CI, 65–82])1
  • Moderate-to-severe hyperkalemia (77% [95% CI, 70–83])1
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Mean serum K+ (mEq/L)TimeWeek 4Week 3Week 2Week 1Day 300.04.24.44.64.85.05.25.45.65.8Serum K+ target range 3.8-<5.1 (mEq/L)Mean chance in serum K+ over 4 weeks, during the initial treatment phase
Adapted from Weir et al, 2015Veltassa® total (N=243) overall populationVeltassa® 16.8 g/day (n=151) moderate-to-severe hyperkalaemiaVeltassa® 8.4 g/day (n=92) mild hyperkalaemia

CKD patients on RAASi therapy (n=243)

CKD 3/4 (eGFR 15–<60 mL/min/1.73m2) with hyperkalemia (sK+ 5.1- <6.5 mEq/L) using RAASi therapy

Mild HK

Baseline sK+ 5.1–5.5 mEq/L; Veltassa® 8.4g/day starting dose (n=92)

Moderate HK

Baseline sK+ 5.5–6.5 mEq/L; Veltassa® 16.8 g/day starting dose (n=151)

Normokalemia Patients

Eligible criteria: Baseline moderate HK patients who fell within the target sK+ range (3.8-5.1 mEq/L) at 4 weeks while receiving RAASi therapy

R

Normokalemia patients receiving RAASi therapy were randomised to receive placebo or Veltassa® for a duration of 8 weeks

Part A: Study endpoints

Primary endpoint

Mean change in sK+ from baseline to Week 4

Secondary endpoint

Proportion of normokalemia patients within sK+ 3.8–5.1 mEq/L at Week 4

Part B: Study endpoints

Primary endpoint

Treatment group differences in median change in sK+ over the first 4 weeks

Secondary endpoint

Proportion of patients with a recurrence of mild (>5.1 mEq/L) or moderate (>5.5 mEq/L) hyperkalemia

Patients with CKD and rHTN (N=295)

Patients eligible for inclusion were aged ≥18 years and older, with an eGFR of 25 to ≤45 mL/min per 1.73m2, serum K+ between 4.3 and 5.1 mmol/L and rHTN

Primary endpoint

Difference between treatment groups in the proportion of patients remaining on spironolactone treatment at Week 12

Secondary endpoint

Difference between treatment groups in the change in systolic AOPB from baseline to Week 12

Week 1

Veltassa® dose titration permitted after 1 week

Week 3

Spironolactone dose titration permitted after 3 weeks

HF Patients (N=104)

CHF patients indicated to receive spironolactone with sK+ 4.3-5.1 mEq/L and:

  • CKD (eGFR <60 mL/min/1.73 m2) and on ≥1 ACEi/ARB or BB

Placebo + spironolactone

Spironolactone 25mg/day (n=49)

Veltassa® + spironolactone

Veltassa® 30 g/day + spironolactone 25mg/day (n=55)

Primary endpoint

  • Mean change in serum K+ levels from baseline to end of the study (Day 28)

Secondary endpoint

  • Proportion of patients with serum K+ 5.5 mEq/L at anytime during the trial
  • Proportion of patients whose spironolactone dose could be increased to 50 mg/day

Mean serum K+ change from baseline to Week 4 for all subjects was -1.01 mEq/L

Significant reduction within 7 h (-0.2 mEq/L; p≤0.004)

Mean serum K+ <5.5 mEq/L within 20 h

Significant K+ reduction (0.75 mEq/L) at 48 h (14 h after last dose)

VELTASSA®

Proven round the clock protection from first dose2

In patients with CKD and hyperkalemia on RAASi therapy, Veltassa® reduced serum K+ levels 4–7 hours after the first dose,2 with mean baseline serum K+ reduced at all subsequent times through 48 hours.2

  • Serum K+ did not increase before the next dose or for 24 hours after the last dose2
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Mean change in serum K+ over timeMean serum K+ (mEq/L)Treatment phaseAdapted from Bushinsky et al, 2015.
Adapted from Bushinsky et al, 2015Mean serum K+ (mEq/L)Treatment phaseBaseline10h24h34h48h58h0.04.55.05.56.0First doseSecond doseThird doseLast doseMean chance in serum K+ over time

VELTASSA®

Veltassa® provides sustained long-term K+ control from the first dose3

In 306 patients with T2DM, CKD, and HTN, treated with RAASi therapy, significant decreases in serum K+ were observed after 4 weeks with Veltassa® and maintained for 1 year3 in up to:

  • 92.7% of patients with mild hyperkalemia3
  • 95.1% of patients with moderate hyperkalemia3
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9/10

Patients with moderate hyperkalemia sustained serum K+ within target range (3.8 to 5.0 mEq/L) over 1-year study period1,2*

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Adapted from Bakris et al, 2015.*Least squares mean (95% CI) serum potassium levels over 52 weeks and during post-treatment follow-up in patients with mild or moderate hyperkalemia (post-hoc mixed-effects models for repeated-measures analysis).** Mild hyperkalemia defined as serum K+ levels >5.0-5.5 mEq/L, moderate hyperkalemia defined as >5.5-<6.0.a At treatment day 3, there were 202 patients with mild hyperkalemia and 82 with moderate hyperkalemia. b At follow-up day 3, there were 163 patients with mild hyperkalemia and 58 with moderate hyperkalemia. c At follow-up week 1, there were 154 patients with mild hyperkalemia and 57 with moderate hyperkalemia. d At follow-up week 3, there were 126 patients with mild hyperkalemia and 48 with moderate hyperkalemia.Veltassa® [16.8 g/day (53.8%), 25.2 g (50.0%), or 33.6 g/day (33.3%)] (n=84) moderate hyperkalaemia**Veltassa® [8.4 g/day (47.3%), 16.8 g (58.9%), or 25.2 g/day (65.8%)] (n=220) mild hyperkalaemia**MildModerate2188320483199731927017565168621616216162163611585315653151531485214949145491314812647No. of patients with hyperkalaemiaSerum K+ (mEq/L)Study visit, wkDay 3a148121620242832364044485243d21cDay 3bBaselineFollow-upTreatment0.04.24.44.64.85.05.25.45.65.8Dicontinuation of Veltassa®Mean chance in serum K+ over 1 year1,2*

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