The Safety of Intravenous Iron Preparations

Avni, Tomer; Bieber, Amir; Grossman, Alon; Green, Hefziba; Leibovici, Leonard; Gafter‐Gvili, Anat

doi:10.1016/j.mayocp.2014.10.007

Cited by 363 publications

(166 citation statements)

References 116 publications

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“…This is in-line with a meta-analysis which reported the safety of iron formulations in different clinical settings and even more so in the subgroup with patients with HF, where the RR for severe adverse events was 0.45 versus any comparator (95% CI 0.29–0.70) [25]. …”

Section: Cost and Adverse Eventssupporting

confidence: 82%

Management of Iron Deficiency in Heart Failure

2019

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Anemia is a common finding in patients with heart failure (HF). The cause for anemia is multifactorial, with iron deficiency being the most common cause. Anemia with HF is an established predictor of morbidity and mortality. Iron deficiency in systolic HF, even without anemia, has been associated with increased mortality, increased hospitalizations, and decreased functional capacity and quality of life measures. Data from several randomized controlled trials and meta-analyses of iron deficiency and systolic HF show a beneficial effect for intravenous (IV) iron in terms of quality of life and functional capacity (improvements in 6-min walk test, and improvements in New York Heart Association functional class), as well as decreased hospitalizations for HF and reduction in cardiovascular mortality rates. Limited evidence exists for a beneficial effect of IV iron in diastolic dysfunction. Patients with symptomatic systolic HF should undergo an anemia diagnostic work-up. When iron deficiency (defined as ferritin <100 ng/mL or serum ferritin 100–299 ng/mL and transferrin saturation <20%) is present, current evidence supports treating HF patients with iron deficiency with IV iron.

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Section: Cost and Adverse Eventssupporting

confidence: 82%

Management of Iron Deficiency in Heart Failure

2019

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“…iron preparations by Avni et al ., showing that i.v. iron is not associated with an increase in severe adverse events 25. Given its efficacy, dosing flexibility, and safety profile compared with other iron preparations such as iron sucrose and ferric gluconate, i.v.…”

Section: Discussionmentioning

confidence: 99%

Single‐dose intravenous iron in Southeast Asian heart failure patients: A pilot randomized placebo‐controlled study (PRACTICE‐ASIA‐HF)

Yeo

Hadi³

et al. 2018

ESC Heart Failure

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AimsIron deficiency is highly prevalent in Southeast Asians with heart failure (HF) and associated with worse outcomes. This trial aimed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF.Methods and resultsFifty patients hospitalized for acute decompensated HF, regardless of ejection fraction, with iron deficiency (defined as serum ferritin <300 ng/mL if transferrin saturation is <20%) were randomized to receive either one dose of intravenous ferric carboxymaltose (FCM) 1000 mg or placebo (0.9% saline) following HF stabilization and before discharge in two Singapore tertiary centres. The primary endpoint was difference in 6‐min walk test (6MWT) distance over 12 weeks, while secondary endpoints were quality of life assessed using validated Kansas City Cardiomyopathy Questionnaire (KCCQ) and Visual Analogue Scale (VAS). Improvement in 6MWT distance at Week 12 was observed in both FCM and placebo groups (from 252 ± 123 to 334 ± 128 m and from 243 ± 67 to 301 ± 83 m, respectively). Unadjusted analysis showed 6MWT distance for FCM exceeded that for placebo, but adjustment for baseline covariates and time attenuated this effect {adjusted mean difference between groups: 0.88 m [95% confidence interval (CI) −30.2 to 32.0, P = 0.956]}. KCCQ overall summary and VAS were similar in both groups [adjusted mean difference: KCCQ −1.48 (95% CI −8.27 to 5.31, P = 0.670) and VAS 0.26 (95% CI −0.33 to 0.86, P = 0.386)]. FCM was well tolerated with no serious treatment‐related adverse events.ConclusionsIntravenous FCM administered pre‐discharge in Southeast Asians hospitalized with decompensated HF is clinically feasible. Changes in 6MWT distance should be measured beyond Week 12 to account for background therapy effects.

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“…Modern iron formulations are associated with a low risk of reactions, and they have fewer adverse effects than oral iron in several studies. In the meta-analysis by Avni et al [29]on the adverse effects of intravenous iron, it was shown in 97 clinical trials that there was no increased risk of serious adverse events compared with controls, and in double-blind trials, there was a trend towards fewer reactions (risk ratio [RR] 0.83, confidence interval 0.64–1.03). When compared to oral iron, the rate of gastrointestinal reactions was significantly less, with a RR of 0.55.…”

Section: Risks Of Intravenous Ironmentioning

confidence: 99%

“…Studies show rates of mild reactions are ∼1 in 200 and major reactions are ∼1 in 200,000 [29]. These are not classic allergic reactions but instead due to activation of the complement system [28, 32].…”

Section: Risks Of Intravenous Ironmentioning

confidence: 99%

Safety of Oral and Intravenous Iron

DeLoughery

2019

Acta Haematol

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As the adverse effects of iron deficiency are better recognized, the use of oral and intravenous iron has increased dramatically. Oral iron is often poorly tolerated, with up to 70% or more of patients noting gastrointestinal issues; this may affect adherence to therapy. In addition, many patients will not respond to oral iron due to their underlying illness. Intravenous iron is being used more frequently to replete iron stores. True anaphylaxis is very rare, but complement-mediated infusion reactions may be seen in up to 1 in every 200 patients. Previous concerns about intravenous iron increasing the risk of infection or cardiovascular disease are unfounded.

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The Safety of Intravenous Iron Preparations

Abstract: Intravenous iron therapy is not associated with an increased risk of SAEs or infections. Infusion reactions are more pronounced with IV iron.

Cited by 363 publications

References 116 publications

Management of Iron Deficiency in Heart Failure

Management of Iron Deficiency in Heart Failure

Single‐dose intravenous iron in Southeast Asian heart failure patients: A pilot randomized placebo‐controlled study (PRACTICE‐ASIA‐HF)

Safety of Oral and Intravenous Iron

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