Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi for HFrEF - DIAMOND

Apr 03, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC
Trial Sponsor:
Vifor Pharma
Date Presented:
04/03/2022
Original Posted Date:
04/03/2022
References

Contribution To Literature:

The DIAMOND trial showed that patiromer was effective at maintaining lower serum potassium levels among patients with heart failure with reduced ejection fraction (HFrEF).

Description:

The goal of the trial was to evaluate patiromer compared with control among patients with HFrEF and history of hyperkalemia.

Study Design

  • Randomized
  • Parallel

Patients with HFrEF and hyperkalemia were randomized to patiromer (n = 439) vs. control (n = 439). Prior to randomization, eligible patients had a run-in phase during which time patiromer was started, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor–neprilysin inhibitor optimized, and mineralocorticoid receptor antagonist (MRA) initiated/optimized. After the run-in phase, patients were randomized to continue patiromer vs. stop patiromer. 

  • Total number of enrollees: 878
  • Duration of follow-up: 13 weeks
  • Mean patient age: 67 years
  • Percentage female: 26%
  • Percentage with diabetes: 42%

Inclusion criteria:

  • HFrEF (left ventricular ejection fraction ≤40%)
  • New York Heart Association class II-IV symptoms
  • On beta-blocker or unable to tolerate beta-blocker
  • Current or history of hyperkalemia

Exclusion criteria:

  • Acute decompensated HF
  • Estimated glomerular filtration rate <30 mL/min/1.73 m2
  • Systolic blood pressure <90 mm Hg
  • Major cardiovascular event within the last 4 weeks

Other salient features/characteristics:

  • Mean serum potassium: 4.6 mEq/L
  • During the run-in phase, 85% of participants were able to be optimized on guideline-directed doses of renin–angiotensin–aldosterone system inhibitors (RAASi)

Principal Findings:

The primary outcome, adjusted mean change in serum potassium from randomization to study end, was 0.03 mEq/L in the patiromer group vs. 0.13 mEq/L in the control group (p < 0.001).

Secondary outcomes:

  • Serum potassium >5.5 mEq/L: 13.9% in the patiromer group vs. 19.4% in the control group (p = 0.006)
  • Reduction in MRA dose below target: 13.9% in the patiromer group vs. 18.9% in the control group (p = 0.006)
  • Hyperkalemia-related outcomes win-ratio: ratio 1.53 (p < 0.001)
  • RAASi use-score win-ratio: ratio 1.25 (p = 0.048)

Interpretation:

Among patients with HFrEF and history of hyperkalemia, patiromer was beneficial. Patiromer was able to maintain lower serum potassium levels and was associated with a lower incidence of severe hyperkalemia (>5.5 mEq/L) compared with control. Patiromer allowed for 85% of participants to be optimized on guideline-directed medical doses of RAASi.

References:

Presented by Dr. Javed Butler at the American College of Cardiology Annual Scientific Session (ACC 2022), Washington, DC, April 3, 2022.

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: ACC22, ACC Annual Scientific Session, Adrenergic beta-Antagonists, Angiotensin Receptor Antagonists, Angiotensin-Converting Enzyme Inhibitors, Heart Failure, Hyperkalemia, Mineralocorticoid Receptor Antagonists, Neprilysin, Potassium, Receptors, Angiotensin, Renin-Angiotensin System, Secondary Prevention, Stroke Volume, Ventricular Function, Left


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