Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease - AMBER

Nov 07, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Relypsa
Date Published:
10/26/2019
Date Updated:
11/07/2019
Original Posted Date:
10/08/2019
References

Contribution To Literature:

The AMBER trial showed that the potassium binder patiromer was effective at allowing more patients to remain on spironolactone.

Description:

The goal of the trial was to evaluate the potassium binder patiromer compared with placebo among patients with uncontrolled resistant hypertension and chronic kidney disease.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded
  • Stratified

Patients who met inclusion criteria were administered open-label spironolactone and randomized to patiromer 8.4 g daily (n = 147) versus placebo daily (n = 148). Spironolactone was initiated at 25 mg daily and increased to 50 mg daily at week 3, if needed.

  • Total number of enrollees: 295
  • Duration of follow-up: 12 weeks
  • Mean patient age: 69 years
  • Percentage female: 48%
  • Percentage with diabetes: 49%

Inclusion criteria:

  • ≥18 years of age
  • Chronic kidney disease (estimated glomerular filtration rate 25 to ≤45 ml/min/1.73 m²)
  • Uncontrolled resistant hypertension
  • Serum potassium between 4.3-5.1 mmol/L

Principal Findings:

The primary outcome, proportion of patients who remained on patiromer at week 12, occurred in 86% of the patiromer group compared with 66% of the placebo group (p < 0.001).

Secondary outcomes:

  • Change in systolic blood pressure from baseline to 12 weeks: -11.7 mm Hg with patiromer vs. -10.8 mm Hg with placebo (between-group difference, p = 0.58)
  • Adverse event leading to study drug discontinuation: 7% with patiromer vs. 14% with placebo

Interpretation:

Among patients with uncontrolled resistant hypertension and chronic kidney disease, the potassium binder patiromer was effective at allowing more patients to remain on spironolactone. Patiromer was safe with few adverse events leading to study drug discontinuation. There was a significant reduction in systolic blood pressure from baseline to 12 weeks in both groups; however, there was no difference in blood pressure between treatment groups.

References:

Agarwal R, Rossignol P, Romero A, et al. Patiromir versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomized, double-blind, placebo-controlled trial. Lancet 2019;394:1540-50.

Editorial Comment: Ganesan C, Pao AC. Spironolactone plus patiromer: proceed with caution. Lancet 2019;394:1486-8.

Keywords: Blood Pressure, Blood Pressure Determination, Geriatrics, Glomerular Filtration Rate, Hypertension, Metabolic Syndrome, Potassium, Primary Prevention, Renal Insufficiency, Chronic, Spironolactone


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