Abstract 14271: Patiromer Controls Hyperkalemia in Resistant Hypertensive Patients on RAASi, With Diabetic Kidney Disease
Introduction: Emerging treatments for hyperkalemia (HK) may have favorable effects on the risk:benefit ratio for pts with HTN and diabetic kidney disease (DKD) treated with RAASi. HK develops in ~7-14% of pts with HTN and DKD, which can limit RAASi dosing and potential cardio-renal benefit.
Hypothesis: This post hoc analysis from the 52-wk AMETHYST-DN study examined the K+-lowering effect of patiromer, an investigational potassium binding polymer, in resistant HTN (RTN) pts with HK and DKD.
Methods: Hypertensive pts with mild (>5.0-5.5 mEq/L) and moderate (>5.5-<6.0 mEq/L) HK and DKD on RAASi were treated with patiromer in an 8-wk treatment initiation phase (TIP), followed by a 44-wk long-term maintenance phase (LTMP). Safety and efficacy were assessed/analyzed in a RTN cohort (defined at baseline [BL], as a SBP >140 mmHg on ≥4 classes of antihypertensive medication including a diuretic).
Results: In AMETHYST-DN, 79/306 pts (67+7 yrs, 51% male) - 64 with mild HK, mean (±SEM) s-K+ 5.18 (0.03) mEq/l, and 15 with moderate HK s-K+ 5.77 (0.04) mEq/l - had RTN on RAASI. Mean (±SD) HR and SBP/DBP were 73 (10) bpm and 156 (10) mmHg / 83 (12) mmHg at BL. At BL stage ≥3b CKD was present in 51/79 pts (65%). Significant reductions in s-K+ from BL occurred at each time point over the 52 wks /end of therapy (ET) (Figure). Investigators could add/modify non-RAASi antihypertensive medications, without known effect on s-K+, for BP control. Similar to the BP changes observed in the intent-to-treat population, at ET the change in mean (±SD) SBP/DBP was -18 (17) mmHg/ -9.0 (13) mmHg in the RTN group. Mean (±SD) change in eGFR from BL was –2.1 (12) mL/min/1.73m2. A total of 5/79 withdrew from study due to a patiromer related AE (hypokalemia 3, constipation 2). Doubling of serum Cr occurred in 7 pts; 1 death occurred during LTMP.
Conclusions: Patiromer effectively controlled HK throughout a 52-wk period in a high-risk cohort of RTN pts, which enabled these pts to continue to use RAASi to control BP.
Author Disclosures: M. Epstein: Honoraria; Modest; Various. Consultant/Advisory Board; Modest; Relypsa, Inc.; Bayer HealthCare; OPKO Health, Inc. M. Mayo: Employment; Significant; Relypsa, Inc. D. Garza: Employment; Significant; Relypsa, Inc. Y. Stasiv: Employment; Significant; Relypsa, Inc. R. Zawadski: Employment; Significant; Relypsa, Inc. L. Berman: Employment; Significant; Relypsa, Inc. D. Wilson: Employment; Significant; Relypsa, Inc. G. Bakris: Consultant/Advisory Board; Modest; Relypsa; Janssen; Medtronic; AbbVie; Takeda; Bayer.
- © 2015 by American Heart Association, Inc.