A Pooled Analysis of Serum Phosphate Measurements and Potential Hypophosphataemia Events in 45 Interventional Trials with Ferric Carboxymaltose
Open Access
- 6 November 2020
- journal article
- research article
- Published by MDPI AG in Journal of Clinical Medicine
- Vol. 9 (11), 3587
- https://doi.org/10.3390/jcm9113587
Abstract
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 n = 49) reached a nadir 43− values and the occurrence of reported adverse events related to low PO43− levels.This publication has 56 references indexed in Scilit:
- Uvanlig bivirkning av et vanlig legemiddelTidsskrift for Den norske legeforening, 2013
- Approach to the Hypophosphatemic PatientJournal of Clinical Endocrinology & Metabolism, 2012
- Hemolytic anemia associated with severe hypophosphatemia in a renal transplant recipientTransplant International, 2011
- Treatment of hypophosphatemia in the intensive care unit: a reviewCritical Care, 2010
- Hypophosphatemia-Induced Seizure in a Child With Diabetic KetoacidosisPediatric Emergency Care, 2009
- FGF23 Elevation and Hypophosphatemia after Intravenous Iron Polymaltose: A Prospective StudyJournal of Clinical Endocrinology & Metabolism, 2009
- Disorders of Iron MetabolismThe New England Journal of Medicine, 1999
- Oral phosphate supplements reverse skeletal muscle abnormalities in a case of chronic fatigue with idiopathic renal hypophosphatemiaNeuromuscular Disorders, 1993
- Prevalence and predictors of rhabdomyolysis in patients with hypophosphatemiaThe American Journal of Medicine, 1992
- Effect of Hypophosphatemia on Myocardial Performance in ManThe New England Journal of Medicine, 1977