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Patiromer and Spironolactone in Resistant Hypertension and Advanced CKD: Analysis of the Randomized AMBER Trial
Rajiv Agarwal1, Patrick Rossignol2, Jeffrey Budden3
1Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
Insights
Patiromer enables sustained spironolactone use in patients with advanced chronic kidney disease (CKD) and resistant hypertension (rHTN). This potassium binder is safe and effective across different CKD stages, improving treatment adherence.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Mineralocorticoid receptor antagonists (MRAs) are crucial for heart failure and resistant hypertension (rHTN).
- Hyperkalemia risk limits MRA use in patients with chronic kidney disease (CKD).
Purpose of the Study:
- To assess the safety and efficacy of patiromer in facilitating spironolactone use in patients with advanced CKD and rHTN.
- To compare patiromer's effectiveness in CKD subgroups (eGFR 25 to <30 and 30-45 ml/min/1.73 m²).
Main Methods:
- The AMBER study was a multicenter, randomized, double-blind, placebo-controlled trial.
- Patients with CKD and rHTN received spironolactone, with or without patiromer.
- A prespecified analysis compared safety and efficacy in advanced CKD subgroups.
Main Results:
- Patiromer significantly increased persistent spironolactone use in both eGFR 25 to <30 (84% vs 56%) and eGFR 30-45 (86% vs 69%) subgroups.
- Systolic blood pressure reductions were observed in both subgroups with spironolactone use.
- Adverse event proportions were similar between the patiromer and placebo groups across subgroups.
Conclusions:
- Patiromer effectively enables sustained spironolactone therapy in patients with rHTN and advanced CKD.
- The efficacy and safety of patiromer are comparable in patients with eGFR 25 to <30 and 30-45 ml/min/1.73 m².
- Patiromer represents a valuable tool for managing resistant hypertension in CKD patients.
Background:
Mineralocorticoid receptor antagonists reduce mortality in patients with heart failure with reduced ejection fraction and have become a standard of care in those with resistant hypertension (rHTN). Yet, their use is limited among patients with CKD, primarily due to hyperkalemia.
Methods:
AMBER was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that reported that the use of the potassium-binding drug patiromer allowed a more persistent use of spironolactone in patients with CKD and rHTN. In this report, we compare the safety and efficacy of patiromer in advanced CKD as a prespecified analysis.
Results:
Of the 295 patients randomized, 66 fell into the eGFR 25 to <30 subgroup. In this subgroup, persistent use of spironolactone was seen in 19 of 34 (56%) in the placebo group and 27 of 32 (84%) in the patiromer group (absolute difference 29%; P<0.02). In the eGFR 30-45 subgroup, persistent use of spironolactone was seen in 79 of 114 (69%) in the placebo group and 99 of 115 (86%) in the patiromer group (absolute difference 17%; P=0.003). There was no significant interaction between eGFR subgroups (P=0.46). Systolic BP reduction with spironolactone in the eGFR 25 to <30 subgroup was 6-7 mm Hg; in the eGFR 30-45 subgroup, it was 12-13 mm Hg. There was no significant interaction between eGFR subgroups on BP reduction (P=0.79). Similar proportions of patients reported adverse events (59% in the eGFR 25 to <30 subgroup; 53% in the eGFR 30-45 subgroup).
Conclusions:
Patiromer facilitates the use of spironolactone among patients with rHTN, and its efficacy and safety are comparable in those with eGFR 25 to <30 and 30-45 ml/min per 1.73 m2.
Clinical Trial Registry Name And Registration Number:
Clinicaltrials.gov, NCT03071263.
