Effect of patiromer on serum potassium in hyperkalemic patients with heart failure: Pooled analysis of 3 randomized trials.
Prog Cardiovasc Dis
; 63(5): 656-661, 2020.
Article
em En
| MEDLINE
| ID: mdl-33007353
ABSTRACT
BACKGROUND:
Hyperkalemia (HK) is a serious medical condition that can cause potentially fatal cardiac arrhythmias. Patients with heart failure (HF) are at risk of HK due to underlying chronic kidney disease and use of guideline-recommended renin-angiotensin-aldosterone system inhibitors. Patiromer, a sodium-free, non-absorbed potassium (K+) binder, is indicated for the treatment of HK.OBJECTIVE:
To evaluate the consistency of patiromer's effect on lowering serum K+ in patients with HF and HK using pooled data from three clinical trials.METHODS:
This post-hoc analysis evaluated the efficacy and safety of patiromer for management of HK over a 4-week treatment period using combined data from three clinical trials (AMETHYST-DN, OPAL-HK and TOURMALINE). Eligible patients had HK (serum K+â¯>â¯5.0â¯mEq/L) at study entry. Starting doses of patiromer ranged from 8.4 to 33.6â¯g/day. In this analysis, efficacy was assessed as the mean (± standard error [SE]) change in serum K+ from baseline to Week 4. Safety outcomes evaluated included the incidence and severity of adverse events (AEs) during the 4-week treatment period.RESULTS:
In total, 653 patients who received ≥1 dose of patiromer were evaluable for efficacy (214 diagnosed with HF and 439 without HF). Mean baseline serum K+ was 5.4â¯mEq/L. Patient characteristics were generally similar between the HF and non-HF subgroups. Serum K+ decreased to <5.0mEq/L within one week of patients starting patiromer, reaching a nadir after 3â¯weeks in both the HF and non-HF subgroups (4.59â¯mEq/L and 4.64â¯mEq/L, respectively). The mean⯱â¯SE change from baseline to Week 4 in serum K+ was -0.79⯱â¯0.06â¯mEq/L (95% CI -0.91, -0.68) in patients with HF andâ¯-â¯0.75⯱â¯0.02â¯mEq/L (95% CI -0.79, -0.70) in patients without HF. AEs occurred in 31% of patients with HF and 37% of patients without HF and were mostly mild or moderate in severity. The most common AEs were constipation (HF patients 7%, non-HF patients 5%) and diarrhea (HF patients 2%, non-HF patients 4%). AEs leading to discontinuation of patiromer occurred in 7% of patients with HF and in 3% of patients without HF.CONCLUSIONS:
In this pooled analysis of patients with HK, patiromer was generally well tolerated and reduced serum K+ similarly in patients with and without HF over 4â¯weeks.Palavras-chave
Texto completo:
1
Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Polímeros
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Potássio
/
Quelantes
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Insuficiência Cardíaca
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Hiperpotassemia
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Guideline
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article