A pooled analysis of serum phosphate measurements and potential hypophosphataemia events in 45 interventional trials with ferric carboxymaltose

  • Ferric carboxymaltose (FCM) has been shown to achieve rapid replenishment of iron stores and correction of anaemia in various populations with iron deficiency. A decrease in serum phosphate (PO43−) levels, which in most cases is asymptomatic, has been reported with IV iron preparations. Hypophosphataemia (HP) is a known adverse drug reaction with FCM. This post hoc pooled analysis investigates the frequency, duration, risk factors, and clinical signs of HP as reported in interventional clinical trials with FCM. Pooled data from subjects enrolled across 45 clinical trials in different therapy areas were included. A three-step adjudication process was utilised to identify adverse events of HP. Stratified analyses by therapy group and stepwise logistic regression analysis were used to identify predictors of HP. This pooled analysis confirms that FCM is associated with increased rates of serum PO43− lowering, but mean serum PO43− values were seen to recover at Week 4 and further recover at Week 8. Among all subjects receiving FCM therapy (n = 6879), 41.4% (n = 2847) reached a PO43− nadir value <2.5 mg/dL at any point on study and 0.7% (n = 49) reached a nadir <1 mg/dL. Although gastroenterology and women’s health subjects were identified to be at higher risk, occurrence of severe HP (<1 mg/dL [0.3 mmol/L]) following FCM administration was not observed to be common among subjects in these studies. Furthermore, there was no correlation between laboratory serum PO43− values and the occurrence of reported adverse events related to low PO43− levels.

Download full text files

Export metadata

Additional Services

Share in Twitter Search Google Scholar
Author:Giuseppe Rosano, Ingolf SchiefkeGND, Udo-Michael Göhring, Vincent Fabien, Stefano Bonassi, Jürgen SteinORCiDGND
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/33172157
Parent Title (English):Journal of Clinical Medicine
Place of publication:Basel
Document Type:Article
Date of Publication (online):2020/11/06
Date of first Publication:2020/11/06
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2020/12/23
Tag:IV iron; ferric carboxymaltose; hypophosphataemia; iron; iron supplements; phosphate; phosphorus
Issue:Article 3587
Page Number:14
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 4.0