Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data

Abstract

BackgroundRecommendations given for intravenous iron treatment are typically not supported by a high level of evidence. This meta-analysis addressed this by summarising the available date from clinical trials of ferric carboxymaltose using clinical trial reports and published reports.MethodsClinical trial reports were supplemented by electronic literature searches comparing ferric carboxymaltose with active comparators or placebo. Various outcomes were sought for efficacy (attainment of normal haemoglobin (Hb), increase of Hb by a defined amount, for example), together with measures of harm, including serious adverse events and deaths.ResultsFourteen studies were identified with 2,348 randomised patients exposed to ferric carboxymaltose, 832 to oral iron, 762 to placebo, and 384 to intravenous iron sucrose. Additional data were available from cohort studies. Intravenous ferric carboxymaltose was given up to the calculated iron deficit (up to 1,000 mg in one week) for iron deficiency anaemia secondary to chronic kidney disease, blood loss in obstetric and gynaecological conditions, gastrointestinal disease, and other conditions like heart failure. The most common comparator was oral iron, and trials lasted 1 to 24 weeks. Intravenous ferric carboxymaltose improved mean Hb, serum ferritin, and transferrin saturation levels; the mean end-of-trial increase over oral iron was, for Hb 4.8 (95% confidence interval 3.3 to 6.3) g/L, for ferritin 163 (153 to 173) μg/L, and for transferrin saturation 5.3% (3.7 to 6.8%). Ferric carboxymaltose was significantly better than comparator in achievement of target Hb increase (number needed to treat (NNT) 6.8; 5.3 to 9.7) and target Hb NNT (5.9; 4.7 to 8.1). Serious adverse events and deaths were similar in incidence in ferric carboxymaltose and comparators; rates of constipation, diarrhoea, and nausea or vomiting were lower than with oral iron.ConclusionsThis review examined the available trials of intravenous ferric carboxymaltose using details from published papers and unpublished clinical trial reports. It increases the evidence available to support recommendations given for intravenous iron treatment, but there are limited trial data comparing different intravenous iron preparations.

Intravenous Iron Therapy in Patients with Idiopathic Pulmonary Arterial Hypertension and Iron Deficiency

“…5,[9][10][11] One reason for using the present approach was that ferric carboxymaltose (Ferinject) is safe to administer in high iron dosages (up to 1,000 mg at one time) and allowed a single visit for every patient. 12 Second, use of the Ganzoni formula may not be reliable in iPAH patients with hypoxemia-driven erythropoiesis and consequent hemoglobin (Hb) levels within the normal range despite iron deficiency. 11,13 Third, previous studies with iron therapy showed that the mean dose of iron needed was around 1,000 mg or even higher.…”

Застосування Внутрішньовенних Препаратів Заліза В Терапії Залізодефіцитної Анемії У Пацієнтів З Хронічною Хворобою Нирок

“…В пределах ограничений данного исследования не наблюдалось почечной токсичности, нового развития сердечно-сосудистых или инфекционных событий. В этом ключе наиболее репрезентативной рабо-той является детальный обзор и метаанализ, опу-бликованный R.A. Moore, H. Gaskell et al, в рамках которого были проанализированы данные практи-чески всех исследований, в которых для коррекции анемии применялся препарат карбоксимальтозата железа [16]. Список исследований включал все про-екты и клинические испытания, в которых прини-мали участие хотя бы десять пациентов.…”

Anemia in Inflammatory Bowel Diseases in Children

“…Применение препарата изучено в большом чис-ле клинических испытаний у разных групп пациентов, при этом феррокинетика проанализирована с помощью позитронной эмиссионной томографии с целью оценки распределения железа после введения препарата [90]. Эффективность лечения препаратом подтверждена дан-ными, приведенными в систематическом обзоре и мета-анализе результатов рандомизированных исследований [91]. В многоцентровом рандомизированном контро-лируемом исследовании эффективность и безопасность инфузий карбоксимальтозата железа изучена у пациен-тов с вторичной ЖДА на фоне ВЗК [92].…”