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Characterization of serum phosphate levels over time with intravenous ferric carboxymaltose versus placebo as treatment for heart failure with reduced ejection fraction and iron deficiency: An exploratory prospective substudy from HEART-FID.
Nouhravesh, Nina; Garg, Jyotsna; Rockhold, Frank W; De Pasquale, Carmine G; O'Meara, Eileen; Lewis, Gregory D; Butler, Javed; Harrington, Josephine; Ezekowitz, Justin A; Ponikowski, Piotr; Troughton, Richard W; Wong, Yee Weng; Blackman, Nicole; Numan, Syed; Adamczyk, Robert; Hernandez, Adrian F; Mentz, Robert J.
Afiliación
  • Nouhravesh N; Duke Clinical Research Institute, Durham, NC, USA.
  • Garg J; Department of Cardiology, Herlev-Gentofte University Hospital, Copenhagen, Denmark.
  • Rockhold FW; Duke Clinical Research Institute, Durham, NC, USA.
  • De Pasquale CG; Duke Clinical Research Institute, Durham, NC, USA.
  • O'Meara E; Flinders Medical Centre, Adelaide, SA, Australia.
  • Lewis GD; Montreal Heart Institute and Université de Montréal, Quebec, Canada.
  • Butler J; Division of Cardiology, Massachusetts General Hospital, Boston, MA, USA.
  • Harrington J; Department of Medicine, University of Mississippi, Jackson, MS, USA.
  • Ezekowitz JA; Duke Clinical Research Institute, Durham, NC, USA.
  • Ponikowski P; Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.
  • Troughton RW; The Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.
  • Wong YW; Department of Medicine, Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.
  • Blackman N; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
  • Numan S; American Regent, Shirley, NY, USA.
  • Adamczyk R; American Regent, Shirley, NY, USA.
  • Hernandez AF; American Regent, Shirley, NY, USA.
  • Mentz RJ; Duke Clinical Research Institute, Durham, NC, USA.
Eur J Heart Fail ; 2024 Jun 19.
Article en En | MEDLINE | ID: mdl-38896006
ABSTRACT

AIMS:

Ferric carboxymaltose (FCM) is guideline-recommended for iron deficiency (ID) in heart failure with reduced ejection fraction (HFrEF). Despite a well-established safety profile, the magnitude and clinical significance of FCM-induced hypophosphataemia in HFrEF remains unclear. This pre-specified substudy of HEART-FID evaluated serum phosphate, 1,25-dihydroxyvitamin D, and plasma parathyroid hormone (PTH) subsequent to FCM. METHODS AND

RESULTS:

HEART-FID was a randomized, double-blind, placebo-controlled trial of ambulatory patients with HFrEF and ID randomized to FCM versus placebo. This substudy assessed mean change from baseline across eight visits over 6 months for the following endpoints serum phosphate, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, and PTH, in addition to the clinical severity of potential hypophosphataemia. Overall, 133 patients (n = 62 FCM, n = 71 placebo) were prospectively enrolled. Mean age was 68 ± 11 years, 55 (41.4%) were women, and 29 (21.8%) had chronic kidney disease. Phosphate levels decreased in 34 (57.6%) patients in the FCM group compared with 7 (10.3%) in the placebo group. Mean change in phosphate levels reached a nadir at day 21 (-0.36 ± 0.27 mmol/L) subsequent to FCM infusion with 28 (51%) having moderate-to-severe hypophosphataemia. Reductions in 1,25-dihydroxyvitamin D were also observed, whilst PTH increased. These biochemical changes returned to baseline levels by day 91. Serum levels of 25-hydroxyvitamin D remained stable throughout the study. No serious adverse events associated with hypophosphataemia were reported.

CONCLUSIONS:

Transient moderate-to-severe hypophosphataemia was frequent subsequent to FCM infusion, accompanied by 1,25-dihydroxyvitamin D decrease and PTH increase. Serum levels of 25-hydroxyvitamin D remained stable. No evidence of symptomatic hypophosphataemia was reported, collectively indicating FCM-related hypophosphataemia to be clinically benign and transient in HFrEF.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Eur J Heart Fail Asunto de la revista: CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Eur J Heart Fail Asunto de la revista: CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido