Henoch-Schonlein purpura in a patient with diabetic nephropathy and vascular complications (original) (raw)
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The Safety of Intravenous Iron Preparations
Mayo Clinic Proceedings, 2015
Objective: To amass all available evidence regarding the safety of intravenous (IV) iron preparations to provide a true balance of efficacy and safety. Methods: Systematic review and meta-analysis of all randomized clinical trials comparing IV iron to another comparator. All electronic databases until January 1, 2014, were reviewed. Primary outcome was occurrence of severe adverse events (SAEs). Secondary outcomes included all-cause mortality and other adverse events (AEs). Subgroup analysis was performed on the basis of type of IV iron, comparator, treated condition, and system involved. Results: A total of 103 trials published between 1965 through 2013 were included. A total of 10,390 patients were treated with IV iron compared with 4044 patients treated with oral iron, 1329 with no iron, 3335 with placebo, and 155 with intramuscular iron. There was no increased risk of SAEs with IV iron (relative risk [RR], 1.04; 95% CI, 0.93-1.17; I 2 ¼9%). Subgroup analysis revealed a decreased rate of SAEs when IV iron was used to treat heart failure (RR, 0.45; 95% CI, 0.29-0.70; I 2 ¼0%). Severe infusion reactions were more common with IV iron (RR, 2.47; 95% CI, 1.43-4.28; I 2 ¼0%). There was no increased risk of infections with IV iron. Gastrointestinal AEs were reduced with IV iron. Conclusion: Intravenous iron therapy is not associated with an increased risk of SAEs or infections. Infusion reactions are more pronounced with IV iron.
Annals of Medicine
Iron deficiency is a common cause of morbidity and can arise as a consequence or complication from many diseases. The use of intravenous iron has increased significantly in the last decade, but concerns remain about indications and administration. Modern intravenous iron preparations can facilitate rapid iron repletion in one or two doses, both for absolute iron deficiency and, in the presence of inflammation, functional iron deficiency, where oral iron therapy is ineffective or has not worked. A multidisciplinary team of experts experienced in iron deficiency undertook a consensus review to support healthcare professionals with practical advice on managing iron deficiency in gastrointestinal, renal and cardiac disease, as well as; pregnancy, heavy menstrual bleeding, and surgery. We explain how intravenous iron may work where oral iron has not. We provide context on how and when intravenous iron should be administered, and informed opinion on potential benefits balanced with potential side-effects. We propose how intravenous iron side-effects can be anticipated in terms of what they may be and when they may occur. The aim of this consensus is to provide a practical basis for educating and preparing staff and patients on when and how iron infusions can be administered safely and efficiently. KEY MESSAGES Iron deficiency treatment selection is driven by several factors, including the presence of inflammation, the time available for iron replenishment, and the anticipated risk of sideeffects or intolerance. Intravenous iron preparations are indicated for the treatment of iron deficiency when oral preparations are ineffective or cannot be used, and therefore have applicability in a wide range of clinical contexts, including chronic inflammatory conditions, perioperative settings, and disorders associated with chronic blood loss. Adverse events occurring with intravenous iron can be anticipated according to when they typically occur, which provides a basis for educating and preparing staff and patients on how iron infusions can be administered safely and efficiently.
Revista Brasileira de Hematologia e Hemoterapia, 2011
Oral iron supplementation is usually the first choice for the treatment of iron deficiency anemia (IDA) because of its effectiveness and low cost. But unfortunately in many iron deficient conditions, oral iron is a less than the ideal treatment mainly because of adverse events related to the gastrointestinal tract as well as the long course required to treat anemia and replenish body iron stores. The first iron product for intravenous use was high-molecular-weight iron dextran. However, dextran-containing intravenous iron preparations are associated with an elevated risk of anaphylactic reactions, which made physicians reluctant to prescribe intravenous iron in the treatment of iron deficiency anemia for many years. In 1999 and 2001, two new intravenous iron preparations (ferric gluconate and iron sucrose) were introduced into the market as safer alternatives to iron dextran. Over the last five years, three new intravenous iron dextran-free preparations have been developed and have better safety profiles than the more traditional intravenous compounds, as none require test doses and all these products are promising in respect to a more rapid replacement of body iron stores (15-60 minutes/infusion) as they can be given at higher doses (from 500 mg to more than 1000 mg/infusion). The purpose of this review is to discuss some pertinent issues in relation to the history, pharmacology, administration, efficacy, safety profile and toxicity of intravenous iron for the treatment of iron deficiency anemia.
Short-term benefits and risks of intravenous iron: a systematic review and meta-analysis
Transfusion, 2007
BACKGROUND: Intravenous (IV) iron may correct anemia more efficiently than oral iron, but it has been associated with allergic and hemodynamic reactions, and it may increase the risks of infectious complications. The objective of this systematic review and metaanalysis was to clarify these controversial issues. STUDY DESIGN AND METHODS: Studies evaluating the use of IV iron compared to enteral or no iron with outcomes within 2 months of treatment initiation were identified. Only randomized controlled trials were included. When a meta-analysis was possible, studies were combined with the Review Manager of the Cochrane Collaboration Group 2003. Statistics were calculated as standardized mean differences (SMDs), with a random-effect model. RESULTS: Thirteen studies met inclusion criteria. Metaanalysis revealed a significant increase in the reticulocyte count (SMD, 0.70; 95% confidence interval [CI], 0.10-1.29; p = 0.02) and in ferritin levels (SMD, 1.18; 95% CI, 0.69-1.68; p = 0.00001), but it also showed that in such a short period of time, IV iron does not correct hemoglobin (Hb)-hematocrit (Hct) better than enteral or no iron. In a sensitivity analysis, however, the increase in Hb-Hct became significant in the nondextran group (SMD, 0.27; 95% CI, 0.04-0.51; p = 0.02). No increase in transferrin saturation was observed. Meta-analysis of the allergic and hemodynamic reactions was not possible as most studies did not clearly describe these outcomes. CONCLUSION: Our results suggest that treatment with nondextran IV iron may benefit a wide variety of patients. Randomized controlled studies are definitively needed to further evaluate the usefulness and safety of IV iron.
Intravenous iron administration: new observations and time for the next steps
Kidney international, 2015
In this issue of Kidney International, the Dialysis Outcomes and Practice Patterns Study reports that hemodialysis patients with monthly intravenous iron supplementation of 300-399 mg or ⩾400 mg had a 13 or 18% higher risk of dying, respectively, compared with those receiving 100-199 mg per month, with no obvious differences in cause-specific mortalities. This study supports that randomized controlled trials are urgently needed to identify optimized iron supplementation strategies for anemic dialysis patients.
BMC Hematology, 2016
Background: Intravenous iron therapy is a treatment option for iron deficient patients who are intolerant to oral iron or where oral iron is ineffective, but with possible adverse effects. Currently, prospective studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents. Methods: We conducted a prospective, double-blind, randomized controlled trial (RCT) to assess the feasibility of a trial comparing the safety of high molecular weight intravenous iron dextran, Infufer®, with intravenous iron sucrose, Venofer®, in non-hemodialysis adult outpatients. Primary outcome was the occurrence of immediate severe drug reactions. Results: We enrolled 143 patients in a one-year period. Overall, 45/143 (31.5 %) patients (20 iron dextran, 25 iron sucrose) developed 48 infusion reactions (14 immediate, 28 delayed, and 3 both). The risk of an immediate reaction was similar in both groups, 9/73 (12.3 %) iron dextran versus 8/70 (11.4 %) iron sucrose, RR = 0.93 (95 % CI; 0.38 to 2.27). The risk of a delayed reaction was significantly higher in the iron sucrose group 22/70 (31.4 %) versus the iron dextran group 9/73 (12.3 %), RR = 2.55 (95 % CI; 1.26 to 5.15; p = 0.0078). Conclusion: In this limited feasibility study, no major differences in immediate reactions were seen, but a significantly higher number of delayed reactions were seen in the iron sucrose group. Further, under our assumptions and design a full RCT to evaluate the safety of different intravenous iron preparations is not feasible. Future studies should consider modifying the clinical outcomes, utilize multiple centers, and consider other emerging parenteral iron formulations. (ClinicalTrials.gov NCT005936197 January 3, 2008).
Safety, therapeutic effectiveness, and cost of parenteral iron therapy
International Journal of Hematology, 2009
Patients have to discontinue the use of oral iron therapy due to the development of side effects and lack of long-term adherence to medication for iron deficiency anemia. This study aimed to evaluate the therapeutic effectiveness, safety, and cost of intravenous iron sucrose therapy. The computerized database and medical records of 453 patients diagnosed with iron deficiency anemia who received intravenous iron sucrose therapy for iron deficiency anemia between 2004 and 2008 were reviewed. The improvement of hematologic parameters and cost of therapy were evaluated 4 weeks after therapy. 453 patients (443 females, 10 males; age: 44.2 ± 12.3 years) received iron sucrose therapy. Mean hemoglobin, hematocrit, and mean corpuscular volume values were 8.2 ± 1.4 g/dL, 26.9 ± 3.8%, and 66.1 ± 7.8 fL, respectively, before therapy and 11.5 ± 1.0 g/dL, 35.8 ± 2.5%, 76.5 ± 6.1 fL, respectively, after therapy (P \ 0.001). A mean ferritin level of 3.4 ± 2.4 ng/mL before therapy increased to 65.9 ± 40.6 ng/mL after therapy (P \ 0.001). All patients responded to intravenous iron therapy (transferrin saturation values of the patients were [50%). The mean cost of therapy was 143.07 ± 29.13 US dollars. The therapy was well tolerated. Although the cost of intravenous iron sucrose therapy may seem high, a lack of adherence to therapy and side effects including gastrointestinal irritation during oral iron therapy were not experienced during intravenous therapy.
International Urology and Nephrology, 2019
Background Parental iron is used to optimize hemoglobin and enhance erythropoiesis in end-stage renal disease along with erythropoietin-stimulating agents. Safety of iron has been debated extensively and there is no definite evidence whether parenteral iron increases the risk of infections and mortality. We performed this meta-analysis to evaluate the incidence of infectious complications, hospitalizations and mortality with use of parenteral iron. Methods Medical electronic databases [PubMed, EMBASE, Scopus, Web of Science, and cochrane central register for controlled clinical trials (CENTRAL)] were queried for studies that investigated the association between intravenous iron administration and infection in hemodialysis patients. 24 studies (8 Randomized control trials (RCTs) and 16 observational studies) were considered for qualitative and quantitative analysis. Results All-cause mortality Data from 6 RCTs show that high-dose IV iron conferred 17% less all-cause mortality compared to controls; however, this outcome was not statistically significant (OR = 0.83, CI [0.7, 1.01], p = 0.07). Nine observational studies were pooled under the random effects model due to significant heterogeneity (I 2 = 83%, p < 0.001). The overall HR showed increased risk of all-cause mortality in the high-dose group but was statistically non-significant (HR = 1.1, CI [1, 1.22], p = 0.06). Infections Four RCTs with no heterogeneity among their data (I 2 = 0%, p = 0.61). Under the fixed effect model, there was no difference in the infection rate between high-dose iron and control group (OR = 0.97, CI [0.82, 1.16], p = 0.77); eight observational studies with significant heterogeneity and utilizing random effects model. Summary HR showed increased yet non-significant risk of infection in the high-dose group (HR = 1.13, CI [0.99, 1.28], p = 0.07) Hospitalization 1 RCT and six observational studies provided data for the rate of all-cause hospitalization. There was marked heterogene-ity among observational studies. RCT showed no significant difference between high-dose iron and controls in the rate of hospitalization (OR = 1.03, CI [0.87, 1.23], p = 0.71). Summary HR for observational data showed increased rate of hospitalization in the high-dose group; however, this effect was not statistically significant (HR = 1.11, CI [0.99, 1.24], p = 0.07). Cardiovascular events One RCT compared the rate of adverse cardiovascular events between high-dose and low-dose iron. No significant difference was observed between the two groups (22.3% vs 25.6%, p = 0.12). Six heterogeneous observational studies (I 2 = 65%, p < 0.001) reported on the rate of cardiovascular events. No significant difference was observed between high-dose iron and controls (HR = 1.18, CI [0.89, 1.57], p = 0.24). Conclusion High-dose parenteral iron does not seem to be associated with higher risk of infection, all-cause mortality, increased hospitalization or increased cardiovascular events on analysis of RCTs. Observational studies show increased risk for all-cause mortality, infections and hospitalizations that were not statistically significant and were associated with significant heterogeneity.