@article{3107353,
    title = "Evaluation of an individualized dose titration regimen of patiromer to prevent hyperkalaemia in patients with heart failure and chronic kidney disease",
    author = "Pitt, B. and Bushinsky, D.A. and Kitzman, D.W. and Ruschitzka, F. and Metra, M. and Filippatos, G. and Rossignol, P. and Du Mond, C. and Garza, D. and Berman, L. and Lainscak, M. and on behalf of the Patiromer-204 Investigators",
    journal = "ESC Heart Failure",
    year = "2018",
    volume = "5",
    number = "3",
    pages = "257-266",
    publisher = "Wiley-Blackwell",
    issn = "2055-5822",
    doi = "10.1002/ehf2.12265",
    keywords = "biological marker;  mineralocorticoid antagonist;  patiromer;  polymer;  potassium;  spironolactone, aged;  blood;  chronic kidney failure;  clinical trial;  combination drug therapy;  complication;  controlled study;  dose response;  female;  follow up;  heart failure;  human;  hyperkalemia;  male;  multicenter study;  randomized controlled trial;  retrospective study;  treatment outcome, Aged;  Biomarkers;  Dose-Response Relationship, Drug;  Drug Therapy, Combination;  Female;  Follow-Up Studies;  Heart Failure;  Humans;  Hyperkalemia;  Male;  Mineralocorticoid Receptor Antagonists;  Polymers;  Potassium;  Renal Insufficiency, Chronic;  Retrospective Studies;  Spironolactone;  Treatment Outcome",
    abstract = "Aims: Hyperkalaemia risk precludes optimal renin–angiotensin–aldosterone system inhibitor use in patients with heart failure (HF), particularly those with chronic kidney disease (CKD). Patiromer is a sodium-free, non-absorbed potassium (K+)-binding polymer approved for the treatment of hyperkalaemia. In PEARL-HF, patiromer 25.2 g (fixed dose) prevented hyperkalaemia in HF patients with or without CKD initiating spironolactone. The current study evaluated the effectiveness of a lower starting dose of patiromer (16.4 g/day) followed by individualized titration in preventing hyperkalaemia and hypokalaemia when initiating spironolactone. Methods and results: This open-label 8-week study enrolled 63 patients with CKD, serum K+ 4.3–5.1 mEq/L, and chronic HF, who, based on investigator opinion, should receive spironolactone. Eligible patients started spironolactone 25 mg/day and patiromer 16.8 g/day (divided into two doses), with patiromer titrated to maintain serum K+ 4.0–5.1 mEq/L. Mean (standard deviation) serum K+ was 4.78 (0.51) mEq/L at baseline; weekly values were 4.48–4.70 mEq/L during treatment. Serum K+ of 3.5–5.5 mEq/L at the end of study treatment (primary endpoint) was achieved by 57 (90.5%) patients; 53 (84.1%) had serum K+ 4.0–5.1 mEq/L. One patient (1.6%) developed hypokalaemia, and two patients (3.2%) developed hypomagnesaemia. Spironolactone was increased to 50 mg/day in all patients; 43 (68%) patients required one or more patiromer dose titration. Adverse events (AEs) occurred in 36 (57.1%) patients, with a low rate of discontinuations [four (6.3%) patients]. The most common AE was mild to moderate abdominal discomfort [four (6.3%) patients]. Conclusions: In this open-label study, patiromer 16.8 g/day followed by individualized titration maintained serum K+ within the target range in the majority of patients with HF and CKD, all of whom were uptitrated to spironolactone 50 mg/day, patiromer was well tolerated, with a low incidence of hyperkalaemia, hypokalaemia, and hypomagnesaemia. © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology."
}