Explore the results of AFFIRM-AHF, a clinical trial that supports
treatment of iron deficiency with Ferinject to improve outcomes in
patients with heart failure
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Ferinject is indicated for the treatment of iron deficiency when: oral iron preparations are ineffective; oral iron preparations cannot be used; or there is a clinical need to deliver iron rapidly. The diagnosis of iron deficiency must be based on laboratory tests.1 |
Ferinject is indicated for the treatment of iron deficiency when: oral iron preparations are ineffective; oral iron preparations cannot be used; or there is a clinical need to deliver iron rapidly. The diagnosis of iron deficiency must be based on laboratory tests.1 |
AFFIRM-AHF highlights the potential of Ferinject® (ferric carboxymaltose)
treatment of iron deficiency to improve outcomes in patients with heart failure
AFFIRM-AHF is the first international, multicentre, double-blind, randomised placebo-controlled trial to compare the effect of Ferinject with placebo on heart failure (HF) re-hospitalisations and cardiovascular (CV) mortality in patients with iron deficiency who were stabilised after an episode of acute HF (N=1,108).2
The study supports the use of Ferinject in patients stabilised after acute HF with concomitant iron deficiency and a left ventricular ejection fraction ≤50%2
AFFIRM-AHF outcomes were evaluated up to 52 weeks after randomisation:2
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Primary endpoint:
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Secondary endpoints:
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Ferinject numerically reduced the risk for the composite endpoint of HF re-hospitalisations and CV death, in patients with iron deficiency and LVEF ≤50% stabilised after an episode of acute HF, but this was not statistically significant (P=0.059)
Primary endpoint: Total HF hospitalisations and CV death
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*mITT population.
Adapted from Ponikowski P et al, 2020.2
ARR, absolute risk reduction; CI, confidence interval; mITT, modified intention-to-treat; RR, rate ratio.
The primary endpoint was driven by a 26% reduction in HF re‑hospitalisation with Ferinject versus placebo with no apparent effect on CV death.2
Secondary endpoint: Total HF re‑hospitalisationsSecondary endpoint - component of primary endpoint
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*mITT population.
Adapted from Ponikowski P et al, 2020.2
ARR, absolute risk reduction; CI, confidence interval; HF, heart failure; mITT, modified intention-to-treat; RR, rate ratio.
View the treatment benefits observed with Ferinject versus placebo in the AFFIRM-AHF study across
other secondary outcomes2
Pre-specified pre-COVID-19 sensitivity analysis
The AFFIRM-AHF study included a pre-specified pre-COVID-19 sensitivity analysis; patient follow-up in each participating country was censored at the date when its first COVID-19 patient was reported.2
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The sensitivity analysis demonstrated a 25% relative risk reduction with Ferinject versus placebo on the composite endpoint of HF hospitalisation and CV death2
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AFFIRM-AHF added to the well-characterised tolerability profile of Ferinject1–3
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Overall incidence of adverse events (AEs), serious AEs, and AEs leading to hospitalisation, withdrawal of treatment, or study discontinuation were similar in the Ferinject and placebo groups2 |
| Ferinject group (N=559)† |
Placebo group (N=551)† |
|||
|---|---|---|---|---|
| n, (%) | Total events | n, (%) | Total events | |
| Most frequent reported event - cardiac disorder events |
224 (40%) | 391 | 244 (44%) | 453 |
| Premature study discontinuation | 159 (28%) | 188 | 175 (31%) | 211 |
| Serious adverse events | 250 (45%) | 547 | 282 (51%) | 632 |
| †Safety population. | ||||
Ferinject has a well-characterised tolerability profile:1
- The most commonly reported adverse drug reaction (ADR) is nausea (3.2%), followed by injection/infusion site reactions, hypophosphataemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare
- The most serious ADR is anaphylactic reactions (rare); fatalities have been reported. Ferinject has a documented frequency of serious hypersensitivity reactions of less than 1 in 1,000. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction)
- Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Ferinject administration
- If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic reactions should be available, including an injectable 1:1,000 adrenaline solution
- Hypophosphataemia is a common (≥1/100 to <1/10) adverse drug reaction. Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery has been reported in the post marketing setting. Patients should be asked to seek medical advice if they experience worsening fatigue with myalgias or bone pain. Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors for hypophosphataemia. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be re-evaluated
Please refer to the Ferinject Summary of Product Characteristics for complete tolerability information
Find out moreSecondary outcomes in the AFFIRM-AHF study in patients with
iron deficiency and LVEF<50% stabilised after acute HF
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First heart failure hospitalisation or CV death occurred in 181/558 (32%) of patients in the Ferinject
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Days lost due to HF hospitalisations and CV death with Ferinject were reduced by 33% versus placebo
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20% reduction in total CV hospitalisations and CV death with Ferinject versus placebo
Similar CV deaths in the Ferinject and placebo groups
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ARR, absolute risk reduction; CI, confidence interval; CV, cardiovascular; HF, heart failure; HR, hazard ratio; RR, rate ratio.
2. Ponikowski P, et al. Lancet 2020;S0140-6736(20)32339-4.
AFFIRM-AHF study design and visit schedule
Adapted from Ponikowski P et al. 2020.2
1. Performed in hospital during the AHF admission (‘Index hospitalisation’). 2. Index hospitalisation discharge after administration of study treatment at the discretion of the investigator. 3. Second dose of study treatment (repletion phase) done at the outpatient visit. 4. Study treatment to be administered only if iron deficiency persists. 5. Telephone contact. 6. Outpatient clinic visit.
AHF, acute heart failure; FCM, ferric carboxymaltose; PL, placebo; V, visit.
2. Ponikowski P, et al. Lancet 2020;S0140-6736(20)32339-4.
ADR, adverse drug reaction; AE, adverse event; ARR, absolute risk reduction; CI, confidence interval; CV, cardiovascular; ESC, European Society of Cardiology; HF, heart failure; RR, rate ratio; ND-CKD, non-dialysis chronic kidney disease.
1. Ferinject Summary of Product Characteristics. 2. Ponikowski P, et al. Lancet 2020;S0140-6736(20)32339-4. 3. McDonagh T, et al. Eur J Heart Fail 2018;20(12):1664–72.
1. Ferinject Summary of Product Characteristics.
2. Ponikowski P, et al. Lancet 2020;S0140-6736(20)
32339-4.
3. McDonagh T, et al. Eur J Heart Fail 2018;20(12)
:1664–72.
Ferinject in patients with ND-CKD
2023 FOCUSED UPDATE OF ESC 2021
HF GUIDELINES
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