Τίτλος:
Evaluation of an individualized dose titration regimen of patiromer to prevent hyperkalaemia in patients with heart failure and chronic kidney disease
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Pitt, B.
Bushinsky, D.A.
Kitzman, D.W.
Ruschitzka, F.
Metra, M.
Filippatos, G.
Rossignol, P.
Du Mond, C.
Garza, D.
Berman, L.
Lainscak, M.
on behalf of the Patiromer-204 Investigators
Περιοδικό:
ESC Heart Failure
Λέξεις-κλειδιά:
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
