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Hypophosphataemia f...
Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD) : A randomised clinical trial
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- Zoller, Heinz (författare)
- Medical University of Innsbruck
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- Wolf, Myles (författare)
- Duke Clinical Research Institute (DCRI)
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- Blumenstein, Irina (författare)
- University Hospital Frankfurt
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- Primas, Christian (författare)
- Medical University of Vienna
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- Lindgren, Stefan (författare)
- Lund University,Lunds universitet,Gastroenterologi,Forskargrupper vid Lunds universitet,Gastroenterology,Lund University Research Groups,Skåne University Hospital
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- Thomsen, Lars L. (författare)
- Pharmacosmos A/S
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- Reinisch, Walter (författare)
- Medical University of Vienna
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- Iqbal, Tariq (författare)
- New Queen Elizabeth Hospital
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(creator_code:org_t)
- 2022-09-09
- 2023
- Engelska.
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Ingår i: Gut. - : BMJ. - 0017-5749 .- 1468-3288. ; 72:4, s. 644-653
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Objective: Intravenous iron - a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD) - can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). Design: This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured. Results: A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration. Conclusion: Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Nyckelord
- anemia
- IBD
- iron deficiency
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
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