Parenteral Iron Therapy: A Single Institution's Experience Over a 5-Year Period

2005 ◽  
Vol 3 (6) ◽  
pp. 791-795 ◽  
Author(s):  
Christopher A. Laman ◽  
Scott B. Silverstein ◽  
George M. Rodgers
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Iron Dextran ◽  
Serious Adverse Events ◽  
Exact Test ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy ◽  
Event Rates

Many patients require parenteral iron therapy for optimal correction of anemia, including cancer patients who require erythropoietic drugs. Available parenteral iron therapy options include iron dextran, iron gluconate, and iron sucrose. The purpose of this study is to summarize our institution's experience with parenteral iron therapy over a 5-year period, with a focus on comparative safety profiles. All patients receiving parenteral iron therapy over this period were included in the analysis. Chi-squared test and Fisher's exact test were used to compare the adverse event rates of each product. A total of 121 patients received 444 infusions of parenteral iron over this period. Iron dextran was the most commonly used product (85 patients) and iron sucrose was the least used (2 patients). Iron gluconate was used by 34 patients. Overall adverse event rates per patient with iron dextran and iron gluconate were 16.5% and 5.8%, respectively (P = .024). Premedication with diphenhydramine and acetaminophen before infusions of iron dextran reduced adverse event rates per infusion from 12.3% to 4.4% (P = .054). Test doses of iron dextran were used 88% of the time for initial infusions of iron dextran. All adverse events for all parenteral iron products were mild or moderate. There were no serious adverse events and no anaphylaxis was observed. Our results suggest that, if test doses and premedications are used, iron dextran is an acceptable product to treat iron deficiency.

scholarly journals Efficacy and safety of intravenous iron sucrose treatment in children with iron deficiency anemia

2019 ◽  
Vol 6 (10) ◽  
pp. 278-283
Author(s):  
Elif Güler Kazancı ◽  
Muhammet Furkan Korkmaz ◽  
Betül Orhaner
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Efficacy And Safety ◽  
Oral Iron Therapy ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy

Objective:  The purpose of this study is to investigate the efficacy and safety of intravenous iron sucrose treatment in children with iron deficiency anemia who were unresponsive to or could not tolerate oral iron therapy. Material and Methods: Among patients determined to have iron deficiency anemia, and were intolerant or noncompliant with oral iron therapy, 92 patients who have received parenteral iron therapy between the ages of 6 months and 18 years have been investigated retrospectively. Age, gender, patient complaints at application,  dietary characteristics, accompanying diseases and treatment complications, and safety, tolerability, and adverse events have been assessed from the information obtained from patient files. Treatment efficiency was evaluated with hemoglobin (Hb), mean corpuscular volume (MCV) and ferritin results from the blood samples taken before treatment, at the second week of treatment and after two months. Results: Mean age of patients was 12.5 ± 4.7 (age interval 1-17 years), and 21% was male while 79% was female. 72% of our patients were adolescents. From an etiological aspect, 56% of our patients was determined to have an iron-poor diet, 29% had functional menorrhagia, and 15% had chronic gastrointestinal system pathologies. Mean Hb, MCV and ferritin levels before and after treatment were found as: 7.72 ± 1.21 g/dl and 11.44 g/dl ± 0.68 g/dl;  63.2 ± 7.12  fL and  76.6 ± 3.81  fL; 3.87 ± 2.52 nmol/L and 57.94 ± 17.19  nmol/L, respectively (p< 0.001). 94% of patients were determined to have at least 2 g/dL (mean value 3.71 [range 1.6-6.3]) increase in their Hb levels. Anaphylaxis was observed in a patient who had a history of allergy despite applying premedication. Conclusion: Parenteral iron therapy is an efficient and safe treatment among indicated patients.

Abstract 15912: Parenteral Iron Sucrose Improves Iron Biomarkers in Pediatric Heart Failure Patients With Iron Deficiency

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Michael J Lin ◽  
Richard Kronmal ◽  
Jessica Otero ◽  
Christa Kirk ◽  
Erin L Albers ◽  
...  
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Clinical Outcomes ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Heart Failure Patients ◽  
Iron Saturation ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy

Introduction: Iron deficiency (FeD) is common in adults with heart failure and is associated with worse outcomes. Parenteral iron therapy improves outcomes in this population, but this has not been described in the pediatric population. Methods: We conducted a prospective observational cohort study of heart failure patients with FeD, defined as ferritin <100 ng/mL or ferritin = 100-300 with iron saturation <20%, who received parenteral iron sucrose between 01/2007-12/2019. Iron dosing and frequency were based on initial and subsequent iron profiles using a standard replacement protocol. Monthly follow-up lab and clinical data up to 6 months were obtained and analyzed to characterize the effect on iron biomarkers and association with clinical outcomes (B-type natriuretic peptide (BNP), death, transplant, and mechanical circulatory support). Results: Among 61 patients who received parenteral iron therapy, 49% were male, with a median age of 23 months (IQR 7 - 117). 30 (49%) had primary cardiomyopathy; 31 (51%) had congenital heart disease with systolic dysfunction, 14 (45%) of which with cyanotic disease. 56 (92%) of the patients had a follow-up iron profile at timepoint 1 (TP 1) at a mean of 24 SD + 9 days. The interval between the 1st dose of iron and last follow-up (TP Last) was 61 + 50 days. The cumulative number of iron doses received was 3.5 + 1.5 at TP 1 and 4.1 + 2.4 at TP Last. Figure 1 shows the trend in iron biomarkers and BNP. There was a statistically significant increase in ferritin, iron saturation and serum iron levels, as well as a decrease in BNP over time. Clinical outcomes were examined by multivariable analysis. Only an increase in ferritin was associated with a decrease in BNP (p=0.012). Conclusions: Parenteral iron therapy for FeD under a standard protocol led to improvement in iron biomarkers in children with heart failure. Our study was limited by a small sample size and further study to assess clinical outcomes specifically related to iron therapy is warranted.

A Retrospective Case Review of Adverse Drug Reactions Using Intravenous Iron in Non-Hemodialysis Patients.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3685-3685
Author(s):  
Cyrus C. Hsia ◽  
Katrina Ormond ◽  
Anagyros Xenocostas ◽  
Ian Chin-Yee
Keyword(s):  
Adverse Events ◽  
Intravenous Iron ◽  
Test Dose ◽  
Hemodialysis Patients ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Iron Dextran ◽  
History Of ◽  
Adult Outpatient ◽  
Intravenous Iron Therapy

Abstract Background: Intravenous iron therapy is commonly used in hemodialysis patients but has not been well studied in other patient populations. Intravenous iron has many documented adverse drug reactions and the types and incidence of reactions differ based on the type of intravenous iron therapy used. In Canada, two forms of iron therapy are currently being used: Iron dextran marketed as Infufer or DexIron and iron sucrose marketed as Venofer are available. The general consensus in the literature is that the incidence of serious adverse reactions is relatively low approximately 0.6–0.7% with intravenous iron dextran. The objective of this retrospective chart review was to observe recorded adverse events of iron dextran (Infufer) and iron sucrose (Venofer) in our own non-hemodialysis patients. Methods: 240 non-hemodialysis adult outpatient charts were reviewed. Iron dextran (Infufer) or iron sucrose (Venofer) infusions were recorded from July 20, 2000 to July 13, 2004. For each chart, the patient age, sex, date of birth, past medical history, medications and allergies were recorded. The type of intravenous iron, if premedication was used, and a description of any reaction if it occurred was also recorded. Each adverse reaction was graded on causality, severity, and system classification based on WHO standards done by two investigators virtually blinded to the type of iron therapy used. Results: Of the 240 patient charts reviewed, there were a total of 403 intravenous iron infusions given within the study period. The age of the patients ranged from 19 to 91 with mean age 60.3 +/− 16.3. The majority of our patients were end-stage renal disease peritoneal dialysis patients 187 (78%). 11 (5%) had a history of connective tissue disease or vasculitis, 15 (6%) had a history of asthma, and 84 (35%) used an angiotension converting enzyme inhibitor (ACEI). Only 17 patients (38 total infusions) received premedication. The total number of adverse events of all descriptions was 103 (26%) of the 403 total intravenous iron infusions. This was equally distributed to males 40 out of 156 (26%) and females 63 out of 247 (26%). Of the 365 intravenous therapies not given premedication there were 89 (24%) adverse events. The total number of "certain severe allergic" reactions (CSAs) was 25/403 (6%). In iron dextran (Infufer) a total of 77/295 (26%) ADRs were noted and CSAs of 23/295 (8%). In iron sucrose (Venofer) there was a total of 26/105 (25%) ADRs and 2/105 (2%) CSAs. Of the 295 intravenous iron dextran infusions, 209 had a test dose given. Of these 209, there were 60 ADRs - 25 during the test dose (12%) and 35 (17%) after the test dose. Conclusions: Adverse events and CSAs in our adult outpatient non-hemodialysis patients receiving intravenous iron therapy with either iron dextran (Infufer) and iron sucrose (Venofer) are much higher than previously reported in the literature. There are more ADRs and CSAs in the iron dextran group than the iron sucrose group. Premedication did not appear to reduce ADRs. Having a normal test dose did not preclude to getting ADRs afterwards.

scholarly journals The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

2021 ◽  
pp. bmjqs-2020-011122 ◽  
Author(s):  
Warren Connolly ◽  
Natasha Rafter ◽  
Ronan M Conroy ◽  
Cornelia Stuart ◽  
Anne Hickey ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Positive Impact ◽  
Retrospective Chart Review ◽  
Published Data ◽  
National Programmes ◽  
Event Rates ◽  
Hospital Associated Infections ◽  
Design And Methods ◽  
The Impact

ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

scholarly journals A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials

2017 ◽  
Vol 14 (2) ◽  
pp. 192-200 ◽  
Author(s):  
Motoi Odani ◽  
Satoru Fukimbara ◽  
Tosiya Sato
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Hierarchical Structure ◽  
Meta Analysis ◽  
Event Data ◽  
Analysis Model ◽  
Exact Test ◽  
Adverse Event Data ◽  
Fisher’S Exact Test

Background/Aim: Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials. Methods: To develop our meta-analysis model, we extended an existing three-stage Bayesian hierarchical model by including an additional stage of the clinical trial level in the hierarchical model; this generated a four-stage Bayesian hierarchical model. We applied the proposed Bayesian meta-analysis models to published adverse event data from three premarketing randomized clinical trials of tadalafil and to a simulation study motivated by the case example to evaluate the characteristics of three alternative models. Results: Comparison of the results from the Bayesian meta-analysis model with those from Fisher’s exact test after simple pooling showed that 6 out of 10 adverse events were the same within a top 10 ranking of individual adverse events with regard to association with treatment. However, more individual adverse events were detected in the Bayesian meta-analysis model than in Fisher’s exact test under the body system “Musculoskeletal and connective tissue disorders.” Moreover, comparison of the overall trend of estimates between the Bayesian model and the standard approach (odds ratios after simple pooling methods) revealed that the posterior median odds ratios for the Bayesian model for most adverse events shrank toward values for no association. Based on the simulation results, the Bayesian meta-analysis model could balance the false detection rate and power to a better extent than Fisher’s exact test. For example, when the threshold value of the posterior probability for signal detection was set to 0.8, the false detection rate was 41% and power was 88% in the Bayesian meta-analysis model, whereas the false detection rate was 56% and power was 86% in Fisher’s exact test. Limitations: Adverse events under the same body system were not necessarily positively related when we used “system organ class” and “preferred term” in the Medical Dictionary for Regulatory Activities as a hierarchical structure of adverse events. For the Bayesian meta-analysis models to be effective, the validity of the hierarchical structure of adverse events and the grouping of adverse events are critical. Conclusion: Our proposed meta-analysis models considered trial effects to avoid confounding by trial and borrowed strength from both within and across body systems to obtain reasonable and stable estimates of an effect measure by considering a hierarchical structure of adverse events.

Parenteral Iron Therapy

2018 ◽  
pp. 80-80
Author(s):  
Shirish Daftary ◽  
Munjal Pandya
Keyword(s):  
Iron Therapy ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy

Efficacy, Safety and Tolerability Of Valsartan Plus HCTZ in Patients With Essential Hypertension: A Multicentre Observational Study in Bangladesh

1970 ◽  
Vol 3 (1) ◽  
pp. 37-44
Author(s):  
MN Islam
Keyword(s):  
Adverse Event ◽  
Essential Hypertension ◽  
Adverse Events ◽  
Global Assessment ◽  
Paired Comparison ◽  
Additional Treatment ◽  
Serious Adverse Events ◽  
Published Evidence ◽  
Bangladeshi Population

Background: Valsartan is an established drug for treatment of essential hypertension. It blocks the action of Angiotensin II irrespective of its sources. A large proportion of patients need additional treatment with two or more drugs of different pharmacological classes for achieving target blood pressure. Published evidence demonstrated synergistic effect of Thiazides with ARB. Coadministration of valsartan and Hydrochlorothiazide has the potential to reverse the untoward effect of each other. Current study aimed at evaluating the efficacy, safety and tolerability of Valsartan plus Hydrochlorothiazide combination, and thus validating the regimen in the treatment of essential hypertension in Bangladeshi population, a population significantly different from Caucasian population where most studies were done. Methods: Current study is a prospective interventional study involving 404 Adult, patients, with Stage I (SBP 140-159 mmHg/DBP 90-99 mmHg) or Stage II (SBP≥160 mmHg/DBP ≥100 mmHg) essential hypertension or patients uncontrolled on current mono-therapy or other combination therapy. Valsartan plus HCTZ 80/12.5 mg once daily tablet were prescribed to continue till the following visit or for the remainder of the study. In case of inadequate control increment in dose was made on the following visit. Patients were assessed at baseline, at 4th weeks, 12th week and 24th week. One of the major outcome parameter set for the study was the percentage of participant having BP controlled that is a SBP <140 mmHg and DBP <90 mmHg or a reduction >10 mmHg for DBP and/ or >20 mmHg SBP versus baseline values at 24 weeks. At final follow-up, in addition to repetition of the baseline measurements and examinations, data on Safety of the drug was collected by enquiring and recording all adverse events or serious adverse events. Global assessment of efficacy and tolerability of treatment was also done by both the physicians and patients on a 4-point scale. Result: The percentage of participant having BP controlled at the end of the trial was 91%. Besides, Significant reduction in mean SBP and mean DBP was also evident (P<.001) through paired comparison from baseline to end of the study. Average reduction of 32.4 ± 19.5 mmHg was seen in systolic BP and 17.4 ± 9.3 mmHg in diastolic BP. Global assessment based on both physician and patients reported greater satisfaction with the efficacy of treatment modality. Total adverse event reported by only six (1.5%) participants. Of the six cases three of the adverse effect was reported at 3rd visit and another three were reported at 4th visit. Total five dropouts (1.24%) were reported of which 1 in 3rd visit and 4 in 4th visit. Among the dropout patient three were withdrawn from the study and two didn’t attend the final follow-up. Global assessment of safety and tolerability based on both physician and patient’s opinion reveals greater satisfaction level with the safety and tolerability of combination treatment. Conclusion: The combination of valsartan and hydrochlorothiazide is an effective treatment for patients with essential hypertension. The combination is also effective in patients not responding to monotherapy with either agent. The drug is found to be well tolerated with minimal adverse event during the course of treatment. Key words: Valsartan; Hydrochlorothiazide; Hypertension. DOI: 10.3329/cardio.v3i1.6425Cardiovasc. j. 2010; 3(1): 37-44

scholarly journals Parenteral iron therapy exacerbates experimental sepsis Rapid Communication

2004 ◽  
Vol 65 (6) ◽  
pp. 2108-2112 ◽  
Author(s):  
Richard A. Zager ◽  
Ali C.M. Johnson ◽  
Sherry Y. Hanson
Keyword(s):  
Iron Therapy ◽  
Experimental Sepsis ◽  
Rapid Communication ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy
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