RESUMO
Iron deficiency anemia (IDA) is common in many chronic diseases, and intravenous (IV) iron offers a rapid and efficient iron correction. This trial compared the efficacy and safety of iron isomaltoside (also known as ferric derisomaltose) and iron sucrose in patients with IDA who were intolerant of, or unresponsive to, oral iron. The trial was an openlabel, comparative, multicenter trial. Five hundred and eleven patients with IDA from different causes were randomized 2:1 to iron isomaltoside or iron sucrose and followed for 5 weeks. The cumulative dose of iron isomaltoside was based on body weight and hemoglobin (Hb), administered as either a 1000 mg infusion over more than 15 minutes or 500 mg injection over 2 minutes. The cumulative dose of iron sucrose was calculated according to Ganzoni and administered as repeated 200 mg infusions over 30 minutes. The mean cumulative dose of iron isomaltoside was 1640.2 (standard deviation (SD): 357.6) mg and of iron sucrose 1127.9 (SD: 343.3) mg. The primary endpoint was the proportion of patients with a Hb increase ≥2 g/dL from baseline at any time between weeks 15. Both noninferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside. For all biochemical efficacy parameters, faster and/or greater improvements were found with iron isomaltoside. Both treatments were well tolerated; 0.6% experienced a serious adverse drug reaction. Iron isomaltoside was more effective than iron sucrose in achieving a rapid improvement in Hb. Furthermore, iron isomaltoside has an advantage over iron sucrose in allowing higher cumulative dosing in fewer administrations. Both treatments were well tolerated in a broad population with IDA.
Assuntos
Anemia Ferropriva/tratamento farmacológico , Dissacarídeos/administração & dosagem , Compostos Férricos/administração & dosagem , Ácido Glucárico/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia Ferropriva/complicações , Dissacarídeos/efeitos adversos , Cálculos da Dosagem de Medicamento , Compostos Férricos/efeitos adversos , Óxido de Ferro Sacarado , Ácido Glucárico/efeitos adversos , Hemoglobinas/análise , Humanos , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Iron deficiency and anaemia occur in particular in women or as comorbid conditions to a varietyof chronic diseases. Besides oral preparations, parenteral iron therapies are also available for the treatment of iron deficiency or anaemia. In the light of the growing importance and increasing number of parenteral iron preparations, theirpharmacology and application as well as the chronology of their approvals and thecharacteristicsof the various preparations are presented herefor comparison. METHOD: Review. RESULTS: To date, there are three different generations of parenteral iron preparations, which differ in terms of stability, safety and dosage. In particular, the active substances of the third generation, ferric carboxymaltose, iron isomaltoside and ferumoxytol are characterised by high complex stability and comparable safety, also allowing rapid application of high doses of iron. CONCLUSIONS: High molecular weight iron dextran, as a representative of 1st generation iron preparations, should no longer be used if possible, as more recent i.v. iron preparations are available with considerably lower risk of serious anaphylactic reactions. Ferrous gluconate and iron sucrose, as representatives of the 2nd generation, are very efficient preparations, but they require frequent visits to the clinic or the doctor, as they may only be administered in low doses because of labile iron complexes. The three 3rd generation parenteral iron formulations have advantages in handling in everyday practice, since they offer comparably good safety profiles, high complex stability and thus the possibility of rapid application of high doses of iron up to the total cumulative dose. Furthermore, test doses are not required with these preparations, which also simplifies their use.
Assuntos
Anemia Ferropriva/tratamento farmacológico , Dissacarídeos/administração & dosagem , Compostos Férricos/administração & dosagem , Óxido Ferroso-Férrico/administração & dosagem , Maltose/análogos & derivados , Dissacarídeos/efeitos adversos , Relação Dose-Resposta a Droga , Substituição de Medicamentos , Compostos Férricos/efeitos adversos , Óxido de Ferro Sacarado , Óxido Ferroso-Férrico/efeitos adversos , Ácido Glucárico/administração & dosagem , Ácido Glucárico/efeitos adversos , Humanos , Infusões Intravenosas , Complexo Ferro-Dextran/administração & dosagem , Complexo Ferro-Dextran/efeitos adversos , Maltose/administração & dosagem , Maltose/efeitos adversos , Relação Estrutura-Atividade , Resultado do TratamentoAssuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/efeitos adversos , Ácido Glucárico/efeitos adversos , Hipofosfatemia/induzido quimicamente , Osteomalacia/induzido quimicamente , Administração Intravenosa , Feminino , Compostos Férricos/administração & dosagem , Compostos Férricos/uso terapêutico , Óxido de Ferro Sacarado , Ácido Glucárico/administração & dosagem , Ácido Glucárico/uso terapêutico , Humanos , Hipofosfatemia/complicações , Hipofosfatemia/diagnóstico , Hipofosfatemia/tratamento farmacológico , Dor Lombar/etiologia , Imageamento por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Osteomalacia/complicações , Osteomalacia/diagnóstico , Osteomalacia/tratamento farmacológico , Dor Pélvica/etiologia , Indução de Remissão , Resultado do TratamentoAssuntos
Anemia Ferropriva/prevenção & controle , Compostos Férricos/uso terapêutico , Hematínicos/uso terapêutico , Falência Renal Crônica/complicações , Diálise Renal/efeitos adversos , Anemia Ferropriva/etiologia , Canadá , Compostos Férricos/administração & dosagem , Compostos Férricos/efeitos adversos , Compostos Férricos/economia , Óxido de Ferro Sacarado , Óxido Ferroso-Férrico/administração & dosagem , Óxido Ferroso-Férrico/efeitos adversos , Óxido Ferroso-Férrico/economia , Óxido Ferroso-Férrico/uso terapêutico , Ácido Glucárico/administração & dosagem , Ácido Glucárico/efeitos adversos , Ácido Glucárico/economia , Ácido Glucárico/uso terapêutico , Hematínicos/administração & dosagem , Hematínicos/efeitos adversos , Hematínicos/economia , Humanos , Infusões Intravenosas , Complexo Ferro-Dextran/administração & dosagem , Complexo Ferro-Dextran/efeitos adversos , Complexo Ferro-Dextran/economia , Complexo Ferro-Dextran/uso terapêutico , Falência Renal Crônica/terapia , Diálise Renal/enfermagemRESUMO
RATIONALE: Saccharated ferric oxide has been shown to lead to elevation of fibroblast growth factor 23, hypophosphatemia, and, consequently, osteomalacia. Moreover, mineral imbalance is often observed in patients with short-bowel syndrome to some degree. PATIENT CONCERNS: A 62-year-old woman with short-bowel syndrome related with multiple resections of small intestines due to Crohn disease received regular intravenous administration of saccharated ferric oxide. Over the course of treatment, she was diagnosed with tetany, which was attributed to hypocalcemia. Additional assessments of the patient revealed not only hypocalcemia, but also hypophosphatemia, hypomagnesemia, osteomalacia, and a high concentration of fibroblast growth factor 23 (314âpg/mL). DIAGNOSES: We diagnosed her with mineral imbalance-induced osteomalacia due to saccharated ferric oxide and short-bowel syndrome. INTERVENTIONS: Magnesium replacement therapy and discontinuation of saccharated ferric oxide alone. OUTCOMES: These treatments were able to normalize her serum mineral levels and increase her bone mineral density. LESSONS: This case suggests that adequate evaluation of serum minerals, including phosphate and magnesium, during saccharated ferric oxide administration may be necessary, especially in patients with short-bowel syndrome.