scholarly journals Iron Replacement Therapy with Oral Ferric Maltol: Review of the Evidence and Expert Opinion

2021 ◽  
Vol 10 (19) ◽  
pp. 4448
Author(s):  
Carsten Schmidt ◽  
Stephen Allen ◽  
Nelson Kopyt ◽  
Pablo Pergola

Iron deficiency is the most common cause of anemia globally and is frequently reported in patients with underlying inflammatory conditions, such as inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Ferric maltol is a new oral iron replacement therapy designed to optimize iron absorption while reducing the gastrointestinal adverse events associated with unabsorbed free iron. Ferric maltol has been studied in clinical trials involving almost 750 adults and adolescents with iron-deficiency anemia associated with IBD, CKD, and other underlying conditions, and it has been widely used in clinical practice. It is approved for the treatment of adults with iron deficiency with or without anemia, independent of the underlying condition, and is commercially available in Europe and the United States. We review the published evidence for ferric maltol, which demonstrates consistent and clinically meaningful improvements in hemoglobin and measures of iron availability (ferritin and transferrin saturation) and shows that it is well-tolerated over long-term treatment for up to 64 weeks—an important consideration in patients with chronic underlying conditions such as IBD and CKD. We believe that ferric maltol is an effective, convenient, and well-tolerated treatment option for iron deficiency and iron-deficiency anemia, especially when long-term management of chronic iron deficiency is required. Writing support was provided by Shield Therapeutics (Gateshead, UK).

2020 ◽  
Vol 13 (2) ◽  
pp. 721-724 ◽  
Author(s):  
Mohammad N. Kloub ◽  
Mohamed A. Yassin

Iron deficiency anemia is common and worldwide distributed, particularly among females; however, it can also occur among males. Iron deficiency anemia is commonly associated with thrombocytosis; little is known about the effect of iron therapy (oral or intravenous) on other hematological parameters. We report a 29-year-old male patient with iron deficiency anemia, who received oral iron replacement therapy and developed neutropenia which recovered spontaneously 1 month later.


Author(s):  
G. Sharma ◽  
S. Gupta ◽  
S. K. Atri ◽  
P. Sharma

Aim: Evaluation of nerve conduction in adult patients of iron deficiency anemia and to study the response to treatment. Study Design: Prospective randomized control study Place and Duration of Study: Department of Medicine and Department of Physiology, PGIMS Rohtak Introduction: Iron deficiency anemia is associated with central and peripheral nervous system disturbances. Iron is an essential component of brain growth, myelination, nerve impulse conduction, protein synthesis, hormone production, fundamental aspects of cellular energy metabolism and is involved in neurotransmitter synthesis including serotonin, norepinephrine and dopamine. Hence, its deficiency adversely affects motor performance, mental development as well as cognitive and behavioral functions. Since myelination is concerned with conduction in nerve fibers, iron deficiency potentially impairs neuronal transmission and leads to functional neurodeficit like dysfunction in the peripheral nervous system such as paresthetic complaints. Method: Nerve conduction was recorded using RMS EMG EP MK2 machine in 30 newly diagnosed patients of iron deficiency anemia with haemoglobin less than 10.9-4 g/dl between 18-50 years of age who were followed up after 3 months of treatment and compared with 30 age and sex matched controls. Results: An increase in distal latencies and a decrease in amplitude and nerve conduction velocities of motor and sensory component of all the nerves was seen in IDA patients as compared to the control groups which was reversible with iron replacement therapy. Conclusion: Altered values of nerve conduction parameters indicates peripheral neuropathy in IDA individuals with or without polyneuropathy. Thus, nerve conduction study provides an objective method for monitoring the function of PNS, especially the clinically silent peripheral nerve compromise in patients of iron deficiency anemia before and after iron replacement therapy.  Thus NCS is a non-invasive test for early diagnosis and therefore early treatment to prevent complications.


Author(s):  
Stefanie Howaldt ◽  
Eugeni Domènech ◽  
Nicholas Martinez ◽  
Carsten Schmidt ◽  
Bernd Bokemeyer

Abstract Background Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. Methods In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. Results For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. Conclusions Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.


2021 ◽  
pp. 1-10
Author(s):  
Pablo E. Pergola ◽  
Diogo Belo ◽  
Paul Crawford ◽  
Moustafa Moustafa ◽  
Wenli Luo ◽  
...  

<b><i>Introduction:</i></b> Ferric citrate (FC) is indicated as an oral iron replacement for iron deficiency anemia in adult patients with chronic kidney disease (CKD) not on dialysis. The recommended starting dose is one 1-g tablet three times daily (TID). This study investigated long-term efficacy and safety of different FC dosing regimens for treating anemia in nondialysis-dependent CKD (NDD-CKD). <b><i>Methods:</i></b> In this phase 4, randomized, open-label, multicenter study, patients with anemia with NDD-CKD (estimated glomerular filtration rate, ≥20 mL/min and &#x3c;60 mL/min) were randomized 1:1 to one FC tablet (1-g equivalent to 210 mg ferric iron) TID (3 g/day) or 2 tablets twice daily (BID; 4 g/day). At week 12, dosage was increased to 2 tablets TID (6 g/day) or 3 tablets BID (6 g/day) in patients whose hemoglobin (Hb) levels increased &#x3c;0.5 g/dL or were &#x3c;10 g/dL. Primary endpoint was mean change in Hb from baseline to week 24. <b><i>Results:</i></b> Of 484 patients screened, 206 were randomized and 205 received FC. Mean (standard deviation) changes from baseline in Hb at week 24 were 0.77 (0.84) g/dL with FC TID 3 g/day and 0.70 (0.98) g/dL with FC BID 4 g/day. <b><i>Discussion/Conclusions:</i></b> FC administered BID and TID for 48 weeks was safe and effective for treating anemia in this population, supporting potentially increased dosing flexibility.


2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Peng Yong Sim ◽  
Priyal Taribagil ◽  
Ione O. C. Woollacott ◽  
Safina Rashid ◽  
Desmond P. Kidd

Abstract Background The presentation of idiopathic intracranial hypertension (IIH) in association with iron deficiency anemia (IDA) is rare. Case presentation This case report depicts the unusual case of a 31-year-old woman of mixed Jamaican and English heritage with IIH who presented initially as IDA in the context of menorrhagia. Subsequent ophthalmic review, lumbar puncture, cerebrospinal fluid analysis and neuroimaging studies revealed severe bilateral optic disc swelling and raised intracranial pressure in keeping with IIH. Prompt treatment of IDA with blood transfusion and orally administered iron supplements, in addition to medical treatment for IIH, contributed to significant improvement of symptoms and prevented long-term visual deficits. Conclusion The possibility of IDA, albeit rare, should always be considered and investigated appropriately in all patients with IIH, as the treatment of the anemia alone may be sight-saving.


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