PMID- 36591361 OWN - NLM STAT- MEDLINE DCOM- 20230103 LR - 20230111 IS - 2641-7650 (Electronic) IS - 2641-7650 (Linking) VI - 3 IP - 12 DP - 2022 Dec 29 TI - Safety and Efficacy of Patiromer in Hyperkalemic Patients with CKD: A Pooled Analysis of Three Randomized Trials. PG - 2019-2026 LID - 10.34067/KID.0001562022 [doi] AB - BACKGROUND: Hyperkalemia is a common electrolyte abnormality in patients with CKD, which is associated with worse outcomes and limits use of renin-angiotensin-aldosterone system inhibitors (RAASi). This post hoc subgroup analysis of three clinical trials evaluated the efficacy and safety of the sodium-free, potassium-binding polymer, patiromer, for the treatment of hyperkalemia in adults with nondialysis CKD. METHODS: Data from the 4-week treatment periods of AMETHYST-DN, OPAL-HK, and TOURMALINE studies were combined. Patients had baseline diagnosis of CKD, hyperkalemia (serum potassium >5.0 mEq/L), and received patiromer 8.4-33.6 g/day. Patients were stratified by baseline eGFR into two subgroups: severe/end-stage CKD (stage 3b-5; eGFR <45 ml/min per 1.73 m(2)) and mild/moderate CKD (stage 1-3a; eGFR >/=45 ml/min per 1.73 m(2)). Efficacy was assessed by the change in serum potassium (mean+/-SE) from baseline to week 4. Safety assessments included incidence and severity of adverse events (AEs). RESULTS: Efficacy analyses (n=626; 62% male, mean age 66 years) included 417 (67%) patients with severe/end-stage CKD and 209 (33%) with mild/moderate CKD. Most patients were receiving RAASi therapy at baseline (severe/end-stage CKD 92%; mild/moderate CKD 98%). The mean+/-SE change in serum potassium (baseline to week 4) was -0.84+/-0.03 in the severe/end-stage CKD subgroup, and -0.60+/-0.04 mEq/L in the mild/moderate CKD subgroup. AEs were reported for 40% and 27% patients in the severe/end-stage and mild/moderate CKD subgroups, respectively, with 16% and 12% reporting AEs considered related to patiromer. The most frequent AEs were mild-to-moderate constipation (8% and 3%) and diarrhea (4% and 2%). AEs leading to patiromer discontinuation occurred in 6% and 2% of patients with severe/end-stage CKD, and mild/moderate CKD, respectively. CONCLUSIONS: Patiromer was effective for treatment of hyperkalemia and well tolerated in patients across stages of CKD, most of whom were receiving guideline-recommended RAASi therapy. CI - Copyright (c) 2022 by the American Society of Nephrology. FAU - Haller, Hermann AU - Haller H AUID- ORCID: 0000-0002-8361-6446 AD - Department of Nephrology and Hypertension, Hannover Medical School, Hanover, Germany. FAU - Bianchi, Stefano AU - Bianchi S AUID- ORCID: 0000-0003-3981-6325 AD - Department of Internal Medicine, Nephrology and Dialysis Complex Operative Unit, Livorno, Italy. FAU - McCafferty, Kieran AU - McCafferty K AUID- ORCID: 0000-0002-0762-2270 AD - Department of Nephrology, Barts Health NHS Trust, London, United Kingdom. FAU - Arthur, Susan AU - Arthur S AD - Biostatistics, Vifor Pharma Group, Redwood City, California. FAU - Quinn, Carol Moreno AU - Quinn CM AUID- ORCID: 0000-0003-2741-3991 AD - Medical Affairs, Vifor Pharma Group, Glattbrugg, Switzerland. FAU - Budden, Jeffery AU - Budden J AD - Medical Affairs, Vifor Pharma Group, Redwood City, California. FAU - Weir, Matthew R AU - Weir MR AUID- ORCID: 0000-0001-8820-5702 AD - Division of Nephrology, University of Maryland School of Medicine, Baltimore, Maryland. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't DEP - 20220802 PL - United States TA - Kidney360 JT - Kidney360 JID - 101766381 RN - 1FQ2RY5YHH (patiromer) RN - 0 (Angiotensin-Converting Enzyme Inhibitors) RN - RWP5GA015D (Potassium) RN - 0 (Polymers) SB - IM MH - Adult MH - Humans MH - Male MH - Aged MH - Female MH - *Hyperkalemia/drug therapy/etiology MH - Angiotensin-Converting Enzyme Inhibitors/adverse effects MH - Randomized Controlled Trials as Topic MH - Potassium/therapeutic use MH - Polymers/adverse effects MH - *Renal Insufficiency, Chronic/complications/drug therapy PMC - PMC9802546 OTO - NOTNLM OT - RAASi OT - chronic kidney disease OT - hyperkalemia OT - patiromer COIS- C. M. Quinn reports having employment with Vifor Pharma; reports having an ownership interest in AstraZeneca and Vifor Pharma; reports receiving research funding from CARE-HK in the Heart Failure registry; reports having patents or royalties with AstraZeneca; and reports having an advisory or leadership role with the Journal of Precision Medicine editorial board. H. Haller reports having consultancy agreements with Alexion, AstraZeneca, Bayer Pharma, Boehringer, MedWiss, Phenos, and Vifor-Fresenius; reports receiving honoraria from Alexion, AstraZeneca, Bayer Pharma, Boehringer, MedWiss, Novartis, Phenos, and Vifor-Fresenius; reports advisory or leadership role with Alexion, Bayer Pharma, Der Internist, and Der Nephrologe; and speakers bureau Amgen, Alexion, AstraZeneca, Bayer Pharma, Boehringer, Novartis, MedWiss, Phenos, and Vifor-Fresenius. J. Budden and S. Arthur report having employment with, and an ownership interest in, Vifor Pharma. K. Mccafferty reports having employment with the National Health Service; reports having consultancy agreements with Oncacare; reports receiving research funding from AstraZeneca; reports receiving honoraria from AstraZeneca, Bayer, Vifor Fresenius, Napp, and Pharmacosmos; and speakers bureau from AstraZeneca and Bayer. M. Weir reports having consultancy agreements with Akebia, AstraZeneca, Bayer, Boehringer-Ingelheim, CareDx, Janssen, Merck, NovoNordisk, and Vifor Pharma, all are modest (<$10,000); reports receiving honoraria and having an advisory or leadership role with Akebia, AstraZeneca, Bayer, Boehringer-Ingelheim, CareDx, Janssen, Merck, NovoNordisk, and Vifor Pharma for ad hoc advisory boards. S. Bianchi reports consultancy and lectures fees from AstraZeneca, Bayer Pharma, Boehringer, Lilly, Novo Nordisk, Pfizer, and Vifor Pharma; and reports being a grant holder for The Italian Ministry of Health. EDAT- 2023/01/03 06:00 MHDA- 2023/01/04 06:00 PMCR- 2022/08/02 CRDT- 2023/01/02 04:52 PHST- 2022/02/23 00:00 [received] PHST- 2022/07/25 00:00 [accepted] PHST- 2023/01/02 04:52 [entrez] PHST- 2023/01/03 06:00 [pubmed] PHST- 2023/01/04 06:00 [medline] PHST- 2022/08/02 00:00 [pmc-release] AID - 02200512-202212000-00007 [pii] AID - K3602022000156 [pii] AID - 10.34067/KID.0001562022 [doi] PST - epublish SO - Kidney360. 2022 Aug 2;3(12):2019-2026. doi: 10.34067/KID.0001562022. eCollection 2022 Dec 29.