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Clinical experience with Veltassa®

RELIABLE K+ CONTROL

LONG-TERM K+ control
Effective regardless of HK severity
Round the clock protection

Mean change in serum K+ over 1 year

Graph: long-term K+ control with Veltassa (mean change over 1 year)
Graph: long-term K+ control with Veltassa (mean change over 1 year)

Veltassa® provides sustained long-term K+ control1

In 306 patients with T2DM, CKD, and HTN, treated with RAASi, significant decreases in serum K+ were observed after 4 weeks with Veltassa® and maintained for 1 year1 in:

  • Up to 92.7% of patients with mild hyperkalaemia
  • Up to 95.1% of patients with moderate hyperkalaemia

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Veltassa® provides sustained long-term K+ control in up to 95% of patients with hyperkalaemia

Mean change in serum K+ over 4 weeks, during the initial treatment phase

Graph: Veltassa is effective regardless of hyperkalaemia severity
Graph: Veltassa is effective regardless of hyperkalaemia severity

Veltassa® significantly lowers K+ and maintains normokalaemia regardless of hyperkalaemia severity2

Among 243 patients with CKD and hyperkalaemia receiving RAASi, 76% had serum K+ in the target range (3.8–<5.1 mEq/L) at Week 42

Similar results in patients with:

  • Mild hyperkalaemia (74% [95% CI, 65−82])
  • Moderate-to-severe hyperkalaemia (77% [95% CI, 70−83])

Mean change in serum K+ over 48 hours

Graph: Veltassa provides round the clock protection
Graph: Veltassa provides round the clock protection

Veltassa® provides sustained K+ control from the first dose 

In patients with CKD and hyperkalaemia on RAASi, Veltassa® resulted in serum K+ reductions 4–7 hours after the first dose,3 with mean baseline serum K+ reduced at all subsequent times through 48 hours

Serum K+ did not increase before the next dose or for 24 hours after the last dose3 

PROVEN RAASi enablement

Veltassa® is proven to enable guideline-recommended RAASi treatment.2,4,5

OPAL (N=243)2

100% RAASi; 42% HF; 100% CKD; 97% HTN; 57% T2DM 

Proportion of patients receiving any RAASi dose  at Week 8 of the randomised withdrawal phase
(exploratory endpoint)

Image: Veltassa enables guideline recommended RAASi treatment

PEARL-HF (N=105)4

100% HF; 57% CKD; 32% T2DM; 98% RAASi

Proportion of patients up-titrated to spironolactone 50 mg/day
(secondary endpoint)

Image: Veltassa enables guideline recommended RAASi treatment

AMBER (N=295)5

100% CKD; 45% HF; 49% T2DM; 100% RAASi

Proportion of patients remaining on spironolactone at Week 12 
(primary endpoint)

Image: Veltassa enables guideline recommended RAASi treatment

Read up on THE VELTASSA® CLINICAL TRIAL PROGRAMME

Real-world evidence supports the benefit of long-term serum K+ control with Veltassa® in patients on RAASi therapy.

Reliable K+ control

In a retrospective observational study with 288 hyperkalaemic patients with HF, T2DM or CKD, Veltassa® decreased serum K+ by an average of -1.0 mEq/L vs before treatment (p<0.001).6

RAASi enablement

In the same study, RAASi therapy was continued in ~80% of patients for 6 months.6

Similarly, in a large US healthcare database including patients with hyperkalaemia, more patients receiving Veltassa® continued RAASi therapy vs those receiving a different serum K+ binder (SPS) or no serum K+ binder.7 

Favourable outcomes

Treatment with Veltassa® was also associated with fewer hospital admissions and emergency department visits.7

Percentage of patients continuing RAASi therapy after Veltassa® initiation6

Bar chart: in real world studies ~80% of patients continue RAASi with Veltassa

Mean concentration and change in serum K+ levels with Veltassa®6

Bar chart: potassium concentration in the months before Veltassa
Bar chart: potassium concentration in the months before Veltassa
Bar chart: potassium concentration in the months before Veltassa

Mean concentration and change in serum K+ levels with Veltassa®6

Bar chart: showing showing pre- and post-Veltassa potassium concentration
Bar chart: showing showing pre- and post-Veltassa potassium concentration
Bar chart: showing showing pre- and post-Veltassa potassium concentration

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2019 HFA expert consensus report considers K+ binders such as Veltassa® to enable RAASi12

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2020 KDIGO guideline considers K+ binders like Veltassa® as an option to manage hyperkalaemia prior to discontinuing RAS blockade13

Favourable safety and tolerability

Veltassa® has demonstrated a positive risk/benefit profile in the clinical trial programme and real-world practice.

  • The majority of the ADRs reported from trials were gastrointestinal disorders and hypomagnesaemia.8
  • GI ADRs were generally mild-to-moderate in nature and did not appear to be dose-related. They generally resolved spontaneously or with treatment, and none was reported as serious.8 
  • No patients developed magnesium levels <1 mg/dL.8 Serum magnesium should be monitored for at least 1 month after initiating treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels.

ADRs IN CLINICAL STUDIES

System Organ Class Common Uncommon
Metabolism and nutrition disorders
 Hypomagnesaemia:
5.3%		  
Gastrointestinal disorders
 Constipation: 6.2%
Diarrhoea: 3%
Abdominal pain: 2.9%
Flatulence: 1.8%		 Nausea
Vomiting
System Organ Class
Metabolism and nutrition disorders
Gastrointestinal disorders
Common
Hypomagnesaemia: 5.3%
Constipation: 6.2%
Diarrhoea: 3%
Abdominal pain: 2.9%
Flatulence: 1.8%
Uncommon
Nausea
Vomiting

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No dose-related oedema observed in over 52 weeks of treatment8

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Hypokalaemia was not identified as an ADR

Veltassa® is suitable for sodium-sensitive patients

  • The use of calcium rather than sodium may make Veltassa® a good choice for patients who cannot tolerate even small increases in sodium, such as patients with HF, CKD, severe hypertension or marked oedema.9

The favourable safety profile observed in clinical trials is supported by evidence from real-world studies.

  • >100,000 patients have been exposed to Veltassa® in real-world practice.10 

There are few known drug−drug interactions with Veltassa®

Concomitant administration of Veltassa® showed reduced bioavailability of only 3 drugs:8

  • Ciprofloxacin
  • Levothyroxine
  • Metformin

No interaction was found with administration of oral drugs at least 3 hours apart from Veltassa®. Quinidine showed a potential drug interaction in vitro. As a precautionary measure, administration of Veltassa® should therefore be separated by at least 3 hours from other oral medicinal products.8

Clinical programme

Efficacy and safety of Veltassa® have been investigated in a range of patients 

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99.4%
receiving RAASi
at baseline

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72.8%
had diabetes

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81.2%
had CKD with eGFR
<60 mL/min/1.73 m2

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48.7%
had HF

AMETHYST-DN

Phase 2, 52-week, multicentre, open-label, dose-ranging study1,11 

Diagram: summary of the AMETHYST-DN phase 2 study

Diagram: summary of the AMETHYST-DN phase 2 study

Diagram: summary of the AMETHYST-DN phase 2 study

 

  • In patients with mild and moderate hyperkalaemia, significant reductions in serum K+ were observed after 4 weeks with Veltassa® and maintained through 52 weeks (p<0.001).
  • The most frequently reported treatment-related AEs were hypomagnesaemia (7.2%), constipation (4.6%) and diarrhoea (2.7%).
  • 9/10 patients with moderate hyperkalaemia sustained serum K+ within the target range (3.8–5.0 mEq/L) over the 1-year study period.
  • Demonstrates the long-term efficacy and safety of Veltassa® in patients with hypertension and diabetic nephropathy.

OPAL-HK

Phase 3, two-part, single blind randomised withdrawal study2 

Diagram: summary of the OPAL-HK phase 3 study

Diagram: summary of the OPAL-HK phase 3 study

Diagram: summary of the OPAL-HK phase 3 study

  • Treatment phase

  • Veltassa® significantly reduced elevated serum K+ values, with overall mean change of −1.01 ± 0.03 mEq/L at Week 4.
  • 76% of patients achieved normokalaemia at Week 4.
  • Most common AE: mild-to-moderate constipation (11%).

  • Randomised withdrawal phase

  • At  Week 4: serum K+ increased in the placebo arm and remained within the normal range in the Veltassa® arm with a between-group difference of 0.72 mm/L per liter.
  • At Week 8: more patients on Veltassa® remained on RAASi (94%) compared with placebo (44%). 
  • Most common AEs: mild-to-moderate constipation, diarrhoea, nausea (all 4%).
  • During the randomised withdrawal phase and through its follow-up period, the proportion of patients with one or more AEs was similar in the placebo group and the Veltassa® group.

PEARL-HF

Phase 2, 4-week, double-blind, randomised, placebo-controlled, parallel-group study4

Diagram: summary of the PEARL-HF phase 2 study

Diagram: summary of the PEARL-HF phase 2 study

Diagram: summary of the PEARL-HF phase 2 study

  • Veltassa® resulted in significantly lower serum K+ levels vs placebo at every measured time point between Day 3 and Week 4, despite an increase in spironolactone dose at Day 15. 
  • Significantly more patients treated with Veltassa® (91%) than placebo (74%; p=0.019) were able to have their spironolactone dose increased to 50 mg.
  • Significantly fewer patients treated with Veltassa® developed hyperkalaemia (serum K+ value >5.5 mEq/L) vs placebo (p=0.015).
  • The most common AEs were GI disorders (e.g. flatulence, diarrhoea, constipation and vomiting), which were reported with higher frequency with Veltassa® (21%) than with placebo (6%).

AMBER

Phase 2, 12-week, randomised, double-blind, placebo-controlled trial5

Diagram: summary of the AMBER phase 2 study

Diagram: summary of the AMBER phase 2 study

Diagram: summary of the AMBER phase 2 study

  • At Week 12, significantly more patients receiving Veltassa®(86%) remained on spironolactone compared with those receiving placebo (66%; p<0.0001).
  • During the study, among patients treated with placebo, 2 out of 3 developed hyperkalaemia with spironolactone. Veltassa® reduced the risk of hyperkalaemia by half in patients on spironolactone (p<0.0001).
  • The safety profile of Veltassa® in this study was consistent with previous reports; the most frequently reported AEs were GI-related.

References & footnotes

ACEi, angiotensin converting enzyme inhibitor; ADR, adverse drug reaction; AE, adverse event; AOBP, automated office blood pressure; ARB, angiotensin II receptor blocker; BB, beta blocker; BID, twice daily; Ca2+, calcium ions; CHF, congestive heart failure; CI, confidence interval; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; GI, gastrointestinal; HF, heart failure; HK, hyperkalaemia; HTN, hypertension; K+, potassium ions; mEqL, milliequivalents per litre; RAASi, renin‐angiotensin‐aldosterone system inhibitors; rHTN, resistant hypertension; sK+, serum potassium; SPS, sodium polystyrene sulfonate; T2DM, type 2 diabetes mellitus; US, United States

Footnotes:    

aLeast squares mean (95% CI) serum potassium levels over 52 weeks and during post-treatment follow-up in patients with mild or moderate hyperkalaemia (post-hoc mixed-effects models for repeated-measures analysis).1
bAt treatment day 3, there were 202 patients with mild hyperkalaemia and 82 with moderate hyperkalaemia.
cAt follow-up day 3, there were 163 patients with mild hyperkalaemia and 58 with moderate hyperkalaemia.
dAt follow-up week 1, there were 154 patients with mild hyperkalaemia and 57 with moderate hyperkalaemia.
eAt follow-up week 3, there were 126 patients with mild hyperkalaemia and 48 with moderate hyperkalaemia.
fThe recommended starting dose of Veltassa® is 8.4 g once-daily. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily.8

References:    

1. Bakris GL, et al. JAMA 2015;314(2):151−61. 2. Weir MR, et al. N Engl J Med 2015;372(3):211−21. 3. Bushinsky DA, et al. Kidney Int 2015;88(6):1427−33. 4. Pitt B, et al. Eur Heart J 2011;32(7):820−8. 5. Agarwal R, et al. Lancet 2019;394(10208):1540−50. 6. Kovesdy CP, et al. Postgrad Med 2020;132:176–83. 7. Desai NR, et al. PLoS One 2020 Jan 7;15(1):e0226844. doi: 10.1371/journal.pone.0226844. 8. Veltassa® SmPC. 9. Li L, et al. J Cardiovasc Pharmacol Ther 2016;21(5):456−65. 10. Data on file, Relypsa Inc. 11. Pitt B, et al. ESC Heart Fail 2018;5(4):592−602. 12. Seferovic PM, et al. Eur J Heart Fail 2019;21:1169–86. 13. KDIGO Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease Kidney Int 2020;98(Suppl 4S):S1–S116.