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Long-term effect of patiromer for hyperkalaemia treatment in patients with HFmrEF and diabetic nephropathy on RAAS inhibitors

Session Poster Session 4

Speaker Bertram Pitt

Congress : Heart Failure 2018

  • Topic : heart failure
  • Sub-topic : Chronic Heart Failure: Clinical, Other
  • Session type : Poster Session
  • FP Number : P2206

Authors : B Pitt (Ann Arbor,US), M Mayo (Redwood City,US), D Garza (Redwood City,US), S Arthur (Redwood City,US), M Lainscak (Murska Sobota,SI)

Authors:
B Pitt1 , M Mayo2 , D Garza2 , S Arthur2 , M Lainscak3 , 1University of Michigan - Ann Arbor - United States of America , 2Relypsa, Inc., a Vifor Pharma Group Company - Redwood City - United States of America , 3General Hospital Murska Sobota - Murska Sobota - Slovenia ,

Citation:

Background: Heart failure (HF) patients (pts) with mid-range ejection fraction (HFmrEF, 40-49%) are an important subgroup requiring further study. Renin-angiotensin-aldosterone system inhibitors (RAASi) have not been shown to reduce mortality in these pts but are often used to manage coexisting conditions, such as hypertension (HTN), diabetes (DM), and CKD, or to provide symptom relief. Chronic hyperkalaemia (HK) and CKD may complicate use of RAASi. Patiromer, a sodium-free nonabsorbed potassium (K+)-binder that uses calcium as the counter-exchange ion, is approved for the treatment of HK, including in the US, the EU, and Australia.
Purpose: The long-term effects of patiromer on serum K+ in HFmrEF pts on RAASi were examined in a post-hoc analysis of AMETHYST-DN.
Methods: Pts with CKD, type 2 DM and HK (baseline K+ >5.0–<6.0 mmol/L) were randomized to patiromer starting doses 8.4–33.6 g/d, divided twice daily. Pts with HTN were eligible if uncontrolled at screening (SBP: >130 to =180mmHg; DBP >80 to =110mmHg). Pts remained on RAASi during study treatment. Changes in mean K+ (central lab) from baseline through 52 wks were evaluated in the HFmrEF subgroup. 
Results: 46/306 randomized pts had HFmrEF (100% Caucasian, 74% male, 72% =65 yr; mean [SD] EF=44 [3] % and eGFR=42 [14] mL/min/1.73m²). All had HTN (baseline mean BP 154/84 mmHg). K+ was reduced to <5.0 mmol/L at the 1st post-baseline visit (day 3) and through 52 wks (Table). Thirty-three (72%) pts reported =1 adverse event (AE); influenza and worsening of CKD were the 2 most common AEs (5 pts each; none severe). Two pts had K+ <3.5 mmol/L; 1 pt had serum Mg <0.49 mmol/L. Mean (SE) change from baseline to 52 wks was: eGFR, +5 (4) mL/min/1.73m²; SBP/DBP, -21 (4)/-10 (2) mmHg.
Conclusions: These post-hoc results suggest that patiromer allows control of HK in HFmrEF pts on RAASi and require prospective evaluation.

Mean serum K+ over 52 weeks in the subgroup of HFmrEF patients
Timepoint (n) Mean serum K+, mmol/L (SE) LSM Δ from baseline in serum K+, mmol/L (SE)
Baseline (n=44)* 5.21 (0.06)

Day 3 (n=42)

4.91 (0.06)

-0.31 (0.06)

Week 4 (n=40)

4.51 (0.06)

-0.64 (0.09)

Week 24 (n=37)

4.60 (0.06)

-0.66 (0.08)

Week 52 (n=31)

4.66 (0.07)

-0.62 (0.10)
From an ANCOVA model with HK stratum at baseline as a fixed effect and baseline serum K+ as a covariate. LSM, least squares mean. Values in parentheses are standard error. *Two patients were excluded from the analysis as they had no central laboratory serum K+ values at baseline.

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