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Safety concerns about intravenous iron therapy in patients with chronic kidney disease.

ABSTRACT: Anaemia in chronic kidney disease (CKD) is managed primarily with erythropoiesis-stimulating agents (ESAs) and iron therapy. Following concerns around ESA therapy, intravenous (IV) iron is being administered more and more worldwide. However, it is still unclear whether this approach is safe at very high doses or in the presence of very high ferritin levels. Some observational studies have shown a relationship between either high ferritin level or high iron dose and increased risk of death, cardiovascular events, hospitalization or infection. Others have not been able to confirm these findings. However, they suffer from indication biases. On the other hand, the majority of randomized clinical trials have only a very short follow-up (and thus drug exposure) and are inadequate to assess the mortality risk. None of them have tested the role of different iron doses on hard end points. With the lack of clear evidence coming from well-designed and large-scale studies, several data suggest that excessive iron therapy may be toxic in several aspects, ranging from iron overload to tissue damage from labile iron. A number of experimental and clinical data suggest that either excessive iron therapy or iron overload may be a possible culprit of atherogenesis. The process seems to be mediated by oxidative stress. Iron therapy should also be used cautiously in the presence of active infections, since iron is essential for bacterial growth. Recently, the European Medicines Agency officially raised concerns about rare hypersensitivity reactions following IV iron administration. The balance has been in favour of benefits. In several European countries, this has created a lot of confusion and somewhat slowed the run towards excessive use. Altogether, IV iron remains a mainstay of anaemia treatment in CKD patients. However, in our opinion, its excessive use should be avoided, especially in patients with high ferritin levels and when ESA agents are not contraindicated.

SUBMITTER: Del Vecchio L

PROVIDER: S-EPMC4792617 | biostudies-other | 2016 Apr

REPOSITORIES: biostudies-other

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Safety concerns about intravenous iron therapy in patients with chronic kidney disease.

Del Vecchio Lucia L Longhi Selena S Locatelli Francesco F

Clinical kidney journal 20160106 2

Anaemia in chronic kidney disease (CKD) is managed primarily with erythropoiesis-stimulating agents (ESAs) and iron therapy. Following concerns around ESA therapy, intravenous (IV) iron is being administered more and more worldwide. However, it is still unclear whether this approach is safe at very high doses or in the presence of very high ferritin levels. Some observational studies have shown a relationship between either high ferritin level or high iron dose and increased risk of death, cardi ...[more]

PMID: 26985378

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Project description:Background Although recommended in the guidelines, the safety of chronic P2Y12 inhibitor therapy in patients with chronic kidney disease ( CKD ) after an acute myocardial infarction ( MI ) is not well studied. Methods and Results The TRANSLATE -ACS (Treatment with ADP Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study included 11 108 MI patients treated with percutaneous coronary intervention and discharged alive on a P2Y12 inhibitor from 233 US hospitals. We compared rates of GUSTO (Global Use of Strategies to Open Occluded Arteries) severe/moderate bleeding and premature discontinuation of P2Y12 inhibitor by 1 year after MI among patients with varying CKD severity. The majority of MI patients treated with percutaneous coronary intervention had CKD : 42% had stage 2 (mild), 27% had stage 3 (moderate), and 4% had stage ≥4 (severe/end stage). Higher potency P2Y12 inhibitors (prasugrel or ticagrelor) were prescribed at discharge in 39%, 35%, 23%, and 15% ( P<0.01) of patients with stages 1, 2, 3, and ≥4, respectively. One-year GUSTO severe/moderate bleeding rates were higher with each stage of CKD : 1% in patients with CKD stage 1 or no CKD , 2% with an adjusted hazard ratio of 1.61 (95% CI, 1.05-2.35) for CKD stage 2, 4% with an adjusted hazard ratio of 1.92 (95% CI, 1.21-3.02) for CKD stage 3, and 10% with an adjusted hazard ratio of 2.44 (95% CI, 1.40-4.23) for patients with CKD stage ≥4. By 1 year after MI , 16% of patients overall had prematurely discontinued P2Y12 inhibitor therapy; however, this rate was not largely affected by CKD stage. Premature P2Y12 inhibitor-discontinuation rates were higher for patients discharged on higher potency P2Y12 inhibitors in patients with CKD stage ≥2 ( P<0.01). Conclusions CKD severity was associated with a higher bleeding risk among those with acute MI treated with a P2Y12 inhibitor. Patients with more advanced CKD were not significantly more likely than those with less advance CKD to prematurely discontinue P2Y12 inhibitor therapy.

Project description:This quality improvement project was conducted at the haemodialysis unit in the paediatric nephrology department at Noah's Ark Children's Hospital, Cardiff. Stakeholders involved were the medical and nursing staff at the haemodialysis unit, responsible for the care of children with chronic kidney disease CKD. Anaemia is prevalent among children with CKD. Iron infusion is administered to such children with chronic anaemia. Children on haemodialysis attending the Children's Kidney Center receive iron infusion if they satisfy the criteria based on haemoglobin and serum ferritin values according to departmental guidelines. This involves measurement of c-reactive protein and serum ferritin prior to iron administration. High iron exposure is detrimental to end organ function and hence warrants regular monitoring in conjunction with CRP, another inflammatory marker. We suspect that some children may be receiving iron infusions despite being iron replete. Also, we may be over-investigating these children with anaemia. We identified all children receiving iron infusion in the haemodialysis unit over a four week period. We retrospectively enquired blood investigations done, prior to and after iron infusion. Blood investigations lagged on pre and post infusion times. We devised a checklist for nursing staff to follow, primarily looking at set times for measuring haemoglobin, serum ferritin, and CRP during the month (at the start of the first and third week of the month) and also tabulating the ferritin values that would trigger frequency of iron infusions. These were aimed to: 1. Prevent iron overloading in patients with chronic anemia 2. Regularise the checking of bloods in those receiving iron infusions 3. Empower the nursing staff to independently take decisions on iron infusion delivery. The strategy for change encompassed multiple PDSA cycles. Plan: empower decision making on iron infusion by haemodialysis nursing staff Do: formulate a checklist for iron infusion based on the recommended set values of ferritin, CRP and haemoglobin Study: analyse adherence to checklist in three months time Act: make appropriate changes to workplace behaviour based on findings of the PDSA cycle We analysed 13 patient episodes prior to the intervention and a total of 19 patient episodes after the improvement cycles. The checklist was improved based on feedback obtained after the first PDSA cycle. A second cycle showed that investigations done were optimised. The third cycle showed improved adherence and compliance with prevention of over-treatment with iron infusion. There was 100% adherence to the investigations done prior to infusion and complied well with the department guidelines. This meant that the required number of blood tests were done on a more regular basis and it did not exceed from those done previously. Nursing behaviour with regard to initiation and maintenance of iron infusion became more independent. This empowered nursing decision making skills and consequently freed doctor-time. It also resulted in improving team morale and ultimately patient safety by mitigating human errors. For any QI project, interventions should be carefully designed. Stakeholder buy-in and easy accessibility of the intervention improves sustainability. Multiple PDSA cycles and incorporating stakeholder feedback into the cycle are key to success.

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Safety concerns about intravenous iron therapy in patients with chronic kidney disease.

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Safety concerns about intravenous iron therapy in patients with chronic kidney disease.

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