Impact of baseline serum ferritin and supplemental iron on altitude‐induced hemoglobin mass response in elite athletes

2021 ◽  
Author(s):  
AE Koivisto‐Mørk ◽  
IS Svendsen ◽  
Ø Skattebo ◽  
J Hallén ◽  
G Paulsen
Keyword(s):  
Serum Ferritin ◽  
Elite Athletes ◽  
Baseline Serum ◽  
Hemoglobin Mass

scholarly journals The prognostic significance of baseline serum ferritin in patients with malignant lymphoma

2018 ◽  
Vol 29 ◽  
pp. ix92
Author(s):  
D.M. El-Habashy ◽  
E.A.R. Tawfik ◽  
S.A. Alhassanin ◽  
A.I. El-Desoky ◽  
A.M.F. Shehata
Keyword(s):  
Malignant Lymphoma ◽  
Serum Ferritin ◽  
Prognostic Significance ◽  
Baseline Serum

Prediction of Response to Recombinant Erythropoietin Plus Granulocyte-Colony Stimulating Factor Following a Single Subcutaneous Bolus in Patients with Myelodysplastic Syndromes; a Randomised Placebo Controlled Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1435-1435
Author(s):  
David Bowen ◽  
Ann Hyslop ◽  
Norene Keenan ◽  
Michael Groves ◽  
Dominic Culligan ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Transferrin Saturation ◽  
Haemoglobin Concentration ◽  
Controlled Study ◽  
Therapeutic Trial ◽  
Recombinant Erythropoietin ◽  
Baseline Serum ◽  
Functional Iron Deficiency ◽  
Erythroid Response

Abstract Recombinant Erythropoietin (+/− G-CSF) is an effective therapy for the anaemia of selected patients with MDS. Validated response prediction models are available, but response rates are only 60% in the “high” predicted response group. Furthermore, half of the total cost of one year’s therapy for a cohort of patients selected for intermediate / high predicted response, is incurred within the initial 12-week therapeutic trial (Cassadeval et al, Blood 2004,104;321). Our hypothesis was that the erythroid response to a single bolus of EPO + G-CSF (Part 1) may predict for sustained response to a therapeutic trial (Part 2). 21 MDS patients (<10% blasts) were randomised in Part 1 to receive either a single s.c. bolus of EPO 18 000 units (NeoRecormon) plus G-CSF (Lenograstim) 263 mcg (n=10), or two vials s.c. placebo (n=11). Serum EPO, haemoglobin concentration and reticulocytes (Sysmex SE9000) were assayed daily from Days 1–8. 20 patients proceeded to Part 2 and received an 8 week therapeutic trial of s.c. EPO 9000 units thrice weekly (tiw), weeks 1–4, escalating to 18 000 units tiw weeks 5–8 if no response, plus titrated s.c. G-CSF tiw. Responders were changed to once weekly (qw) EPO dosing from weeks 12–20 at the total weekly responding dose. 6 patients had erythroid response by study response criteria and 7 by IWG criteria (2HI-E major, 5 HI-E minor). 4/7 RARS patients responded. Incremental change in absolute reticulocyte counts between Day 1 and Day 8 of Part 1 discriminated responders (median increment = 40x109/l, range 31–81, n=6), who received bolus EPO/G-CSF, from non-responders who also received bolus EPO/GSCF (median increment = 1.5x109/l, range −14 to 6, n=4) and from patients receiving placebo (median increment = 5x109/l, range −21 to 18, n=11)(ANOVA P=.002). An incremental increase of >30x109/l was 100% predictive of subsequent response. In patients with erythroid response in Part 2, haemoglobin concentration at qw EPO either did not change compared to tiw dosing (P>.05, n=5), or increased (P=.002, n=1). Serum ferritin, transferrin saturation, CHr (Bayer Advia) and serum transferrin receptor (TfR)concentrations were assayed weekly. Two patients became biochemically iron deficient during weeks 1–8, both of whom had baseline serum ferritin <100mg/l. No iron supplementation was given, and one patient still had an erythroid response. No clear evidence for functional iron deficiency was seen in patients with serum ferritin >100 mg/l. Serum non-transferrin bound iron concentration correlated closely with transferrin saturation both at baseline (n=21 patients), and on treatment (n=4 responders and 4 non-responders). In Part 2, neither ΔHb, nor ΔTfR at weeks 1 or 2 predicted response. No baseline erythroid parameters differed between responders and non-responders. New observations: 1. Absolute reticulocyte increment at Day 8 post s.c. bolus EPO/G-CSF predicts for therapeutic response in this small study, 2. Once weekly EPO is as effective as thrice weekly EPO in similar doses, 3. Functional iron deficiency may impair response in MDS patients with iron-limited erythropoiesis.

The Palatability and Tolerability of Deferasirox (Exjade®) Taken with Meals, Different Liquids, or Crushed and Added to Food

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5155-5155
Author(s):  
Stuart L Goldberg ◽  
Patricia Giardina ◽  
Joan Parkhurst Cain ◽  
Deborah Chirnomas ◽  
Jason Esposito ◽  
...  
Keyword(s):  
Adverse Events ◽  
Serum Ferritin ◽  
Research Funding ◽  
Chelation Therapy ◽  
Iron Chelation ◽  
Thalassemia Major ◽  
Iron Chelation Therapy ◽  
Age Group ◽  
Baseline Serum ◽  
Off Label

Abstract Abstract 5155 Introduction: Deferasirox (Exjade®, Novartis Pharmaceuticals) is an oral iron chelator indicated for the treatment of transfusional iron overload. The recommended mode of administration is to be taken on an empty stomach in water, apple juice or orange juice ≥30 minutes before food. However, there have been post-marketing reports of discontinuation or reduced compliance of deferasirox secondary to palatability and gastrointestinal adverse events. Registration trials with deferasirox did not evaluate different food combinations in an attempt to maintain predictable plasma levels. Early single dose studies suggested that the bioavailability of deferasirox is increased when administered with or before meals, and is positively influenced by fat content, but is not affected by degree of dispersion nor type of liquid. Long-term pharmacokinetic and tolerability studies involving a food effect have not been conducted to date, and the ability of alternate methods of administration to improve patient compliance with iron chelation therapy is unknown. Method: This is an ongoing single-arm, open-label, multi-center study designed to evaluate the palatability, safety, tolerability and pharmacokinetics of deferasirox when administered with food, dispersed in any liquid of choice, or crushed and added to food. The patient population includes patients with transfusional hemosiderosis (minimum entry serum ferritin ≥500 μ g/L) aged >2 years with thalassemia major, sickle cell disease (SCD), low or intermediate (INT-1) risk MDS or other anemias, who are on, starting, or resuming treatment with deferasirox. The study began with a 1-month run-in phase with deferasirox dosed according to prescribing information, then a 3-month assessment phase where subjects could choose each week from 5 general administration options including with or without meals, in the morning or evening, crushed and added to a soft food, or mixed in a liquid of choice. Subject diaries are used to record the meal and method of administration at the end of each week. Palatability is assessed with a modified facial hedonic scale, with additional directed questions capturing gastrointestinal side effects. This is a data analysis of the run-in phase. Result: Target enrollment has been met with 65 patients. Baseline data on the first 58 subjects include 8 in the 2 to <10 years of age group (median 7.5 years; range 3–9); 42 in the 10 to <60 years of age group (median 18.5 years; range 10–48); and 8 in the ≥60 years of age group (median 74 years; range71-83). Underlying hematologic diagnoses included SCD (41%), thalassemia major (29%), MDS (12%) and other anemias (17%). Sixty-nine percent of subjects were receiving deferasirox prior to entering the study. The median baseline serum ferritin level was 2405 μ g/L (range 560–8660) and was distributed as shown in Table 1. The most frequent adverse events were diarrhea (19%) and nausea (9%) (Table 2), which were more common in MDS (P=0.23 and P<0.01, respectively). Conclusion: This ongoing trial (NCT00845871) is evaluating whether alternative modes of administration improve palatability and tolerability while maintaining safety. Preliminary data from the assessment phase (deferasirox taken with meals, different liquids, or crushed and added to food) will be presented at the meeting. Disclosures: Goldberg: Novartis Oncology: Consultancy, Honoraria, Research Funding, Speakers Bureau. Off Label Use: Exjade, iron chelation therapy, off-label method of administration. Giardina:Novartis: Research Funding. Parkhurst Cain:Novartis: Research Funding. Chirnomas:Novartis: Research Funding. Esposito:Novartis: Employment. Paley:Novartis: Employment. Vichinsky:Novartis: Consultancy, Research Funding, Speakers Bureau; Hemaquest: Consultancy, Membership on an entity's Board of Directors or advisory committees; Apotex: Consultancy, Research Funding.

Insights into Relationships Between Serum Ferritin and Liver Iron Concentration Trends during 12 Months of Iron Chelation Therapy with Deferasirox – a Post-Hoc Analysis from the Epic Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 52-52 ◽  
Author(s):  
John B Porter ◽  
Mohsen Elalfy ◽  
Ali T Taher ◽  
Lee Lee Chan ◽  
Szu-Hee Lee ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Serum Ferritin ◽  
Research Funding ◽  
Chelation Therapy ◽  
Iron Concentration ◽  
Iron Intake ◽  
Advisory Committees ◽  
Liver Iron ◽  
Baseline Serum ◽  
Post Hoc

Abstract Background Serum ferritin is regularly used to assess response to chelation therapy and correlates significantly with liver iron concentration (LIC) particularly when LIC is <7 mg Fe/g dry weight (dw) and serum ferritin is <4000 ng/mL. The absence of a serum ferritin decrease in the first months of a new chelation regime may be interpreted as a lack of response with respect to decreasing body iron load. However, sequential LIC determination (where available) has indicated that many of these patients do indeed have a decrease in LIC. This clinical experience requires greater understanding, particularly the nature of the LIC and serum ferritin relationship at baseline serum ferritin values ≥4000 ng/mL. The aim of this post-hoc analysis of the EPIC study was to gain insight into the relationship between serum ferritin and LIC in response to deferasirox over 1 year, in a large patient cohort, so that serum ferritin trends can be more clearly interpreted and evidence-based practical guidance be given for patients with transfusion-dependent thalassemia (TDT). Methods TDT patients were recruited from 25 sites, received 1-year of deferasirox treatment and had serum ferritin and R2 magnetic resonance imaging (R2-MRI)-assessed LIC measurements at baseline and 1 year. Summary statistics are provided for serum ferritin and LIC responders (decrease, any change from baseline <0) and nonresponders (increase or no change, any change from baseline ≥0), and for baseline serum ferritin categories (≥4000 vs <4000 ng/mL). Results Of the 374 patients analyzed in the EPIC liver MRI substudy, 317 had TDT, of which 72.7% (n=226) had a serum ferritin response and 27.3% (n=85) had no response. Importantly, after 1 year LIC decreased in approximately half of serum ferritin nonresponders (51.8%; n=44; Table) and in 79.6% of serum ferritin responders (n=180). Median (min, Q1, Q3, max) change in LIC (mg Fe/g dw) was –5.4 (–38.5, –11.7, –0.9, 15.4) in serum ferritin responders and –0.2 (–18.4, –2.6, 2.7, 19.6) in nonresponders. Median (range) transfusional iron intake (mg/kg/day) was similar in serum ferritin responders (0.30 [0.01–1.49]) and nonresponders (0.37 [0.02–1.00]). Median deferasirox dose (mg/kg/day) was higher in serum ferritin responders than nonresponders (28.1 [9.8–40.4] vs 23.7 [9.7–37.9]). Evaluation of responses by baseline serum ferritin showed that a greater proportion of serum ferritin responders with baseline serum ferritin <4000 ng/mL also had decreased LIC (88.7% [n=102]; Table), compared with serum ferritin responders with baseline serum ferritin ≥4000 ng/mL (70.3% [n=78]). However, serum ferritin baseline category had no effect on the proportion of patients who decreased LIC despite having no serum ferritin response (52.6% [n=30], <4000 ng/mL; 50.0% [n=14], ≥4000 ng/mL; Table). There was little change in median LIC in serum ferritin nonresponders after 1 year regardless of baseline serum ferritin value (–0.3 [–13.5–18.7] for <4000 ng/mL and 0.2 [–18.4–19.6] for ≥4000 ng/mL). Assessment by change in serum ferritin and LIC quadrants indicated that patients without serum ferritin or LIC response had the lowest baseline median (range) serum ferritin and LIC (2155 [480–9725] ng/mL; 11.9 [1.8–37.5] mg Fe/g dw; n=41), and received a lower median deferasirox dose (23.7 [9.7–36.0] mg/kg/day). Overall, median LIC decrease (mg Fe/g dw) was smaller in patients with baseline serum ferritin <4000 ng/mL (n=172) than in those with serum ferritin ≥4000 ng/mL (–2.8 [–38.5–18.7] vs –4.9 [–31.1–19.6]; n=139). Median iron intake was similar between groups. Discussion and conclusions A decrease in LIC was seen in ~80% of serum ferritin responders after 1 year of deferasirox; a greater proportion of serum ferritin responders (88%) decreased LIC when baseline serum ferritin was <4000 ng/mL. Importantly, among patients with no serum ferritin response up to half may be responding with respect to iron balance, indicating that a lack of serum ferritin response should be interpreted with caution. However, since a decrease in serum ferritin predicts a decrease in LIC in 80% of patients, MRI measurement (where available) should be prioritized for patients with serum ferritin increase/no change. Overall, serum ferritin response can help predict LIC response, but in some patients treated with deferasirox, serum ferritin may not accurately reflect removal of iron from the body. Figure 1 Figure 1. Disclosures Porter: Novartis: Consultancy, Honoraria, Research Funding; Shire: Consultancy, Honoraria; Celgene: Consultancy; Cerus: Membership on an entity's Board of Directors or advisory committees; Alnylam: Membership on an entity's Board of Directors or advisory committees. Taher:Novartis: Honoraria, Research Funding. Sutcharitchan:Novartis: Research Funding. Aydinok:Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Chakravarty:Novartis: Employment. El-Ali:Novartis: Employment.

scholarly journals The Effectiveness of Transdermal Iron Patches in Athletes With Suboptimal Iron Status (Part 1)

2020 ◽  
Vol 30 (3) ◽  
pp. 185-190 ◽  
Author(s):  
Rachel McCormick ◽  
Brian Dawson ◽  
Marc Sim ◽  
Leanne Lester ◽  
Carmel Goodman ◽  
...  
Keyword(s):  
Serum Ferritin ◽  
Repeated Measures ◽  
Iron Status ◽  
Maximal Oxygen Consumption ◽  
Oral Iron ◽  
Iron Stores ◽  
Beneficial Effects ◽  
Parallel Group ◽  
Gastrointestinal Side Effects ◽  
Hemoglobin Mass

The authors compared the effectiveness of two modes of daily iron supplementation in athletes with suboptimal iron stores: oral iron (PILL) versus transdermal iron (PATCH). Endurance-trained runners (nine males and 20 females), with serum ferritin concentrations <50 μg/L, supplemented with oral iron or iron patches for 8 weeks, in a parallel group study design. Serum ferritin was measured at baseline and fortnightly intervals. Hemoglobin mass and maximal oxygen consumption () were measured preintervention and postintervention in PATCH. A linear mixed effects model was used to assess the effectiveness of each mode of supplementation on sFer. A repeated-measures analysis of variance was used to assess hemoglobin mass and outcomes in PATCH. There was a significant time effect (p < .001), sex effect (p = .013), and Time × Group interaction (p = .009) for sFer. At Week 6, PILL had significantly greater sFer compared with PATCH (15.27 μg/L greater in PILL; p = .019). Serum ferritin was 15.53 μg/L greater overall in males compared with females (p = .013). There were no significant differences in hemoglobin mass (p = .727) or (p = .929) preintervention to postintervention in PATCH. Finally, there were six complaints of severe gastrointestinal side effects in PILL and none in PATCH. Therefore, this study concluded that PILL effectively increased sFer in athletes with suboptimal iron stores, whereas PATCH showed no beneficial effects.

Blood Volume and Hemoglobin Mass in Elite Athletes of Different Disciplines

2001 ◽  
Vol 22 (7) ◽  
pp. 504-512 ◽  
Author(s):  
K Heinicke ◽  
B Wolfarth ◽  
P Winchenbach ◽  
B Biermann ◽  
A Schmid ◽  
...  
Keyword(s):  
Blood Volume ◽  
Elite Athletes ◽  
Hemoglobin Mass

scholarly journals Serum Ferritin Variations and Mortality in Incident Hemodialysis Patients

2017 ◽  
Vol 46 (2) ◽  
pp. 120-130 ◽  
Author(s):  
Taehee Kim ◽  
Elani Streja ◽  
Melissa Soohoo ◽  
Connie M. Rhee ◽  
Rieko Eriguchi ◽  
...  
Keyword(s):  
Serum Ferritin ◽  
Intravenous Iron ◽  
Baseline Serum ◽  
Mortality Hazard ◽  
Risk Of Mortality ◽  
All Cause Mortality ◽  
Slight Rise ◽  
Mortality Hazard Ratio ◽  
Dose Change ◽  
Median Change

Background: Higher serum ferritin levels may be influenced by iron use and inflammation, and are associated with higher mortality in hemodialysis (HD) patients. We hypothesized that a major rise in serum ferritin is associated with a higher risk of mortality, irrespective of baseline serum ferritin in incident HD patients. Methods: In a cohort of 93,979 incident HD patients between 2007 and 2011, we examined the association of change in serum ferritin from the baseline patient quarter (first 91 days from dialysis start) to the subsequent quarter with mortality. Multivariable adjustments were done for case-mix and markers of the malnutrition, and inflammation complex and intravenous iron dose. Change in serum ferritin was stratified into 5 groups: <-400, -400 to <-100, -100 to <100, 100 to <400, and ≥400 ng/mL/quarter. Results: The median change in serum ferritin was 89 ng/mL/quarter (interquartile range -55 to 266 ng/mL/quarter). Compared to stable serum ferritin (-100 to <100 ng/mL/quarter), a major rise (≥400 ng/mL/quarter) was associated with higher all-cause mortality (hazard ratio [95% CI] 1.07 [0.99-1.15], 1.17 [1.09-1.24], 1.26 [1.12-1.41], and 1.49 [1.27-1.76] according to baseline serum ferritin: <200, 200 to <500, 500 to <800, and ≥800 ng/mL in adjusted models, respectively. The mortality risk associated with a rise in serum ferritin was robust, irrespective of intravenous iron use. Conclusions: During the first 6-months after HD initiation, a major rise in serum ferritin in those with a baseline ferritin ≥200 ng/mL and even a slight rise in serum ferritin in those with a baseline ferritin ≥800 ng/mL are associated with higher mortality.

scholarly journals Prospective Changes of Pancreatic Iron in Thalassemia Major

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3084-3084
Author(s):  
Alessia Pepe ◽  
Laura Pistoia ◽  
Crocetta Argento ◽  
Luciana Rigoli ◽  
Monica Benni ◽  
...  
Keyword(s):  
Iron Overload ◽  
Board Of Directors ◽  
Serum Ferritin ◽  
Iron Concentration ◽  
Pancreatic Head ◽  
Thalassemia Major ◽  
Common Finding ◽  
Inverse Association ◽  
Advisory Committees ◽  
Baseline Serum

Abstract Introduction. Pancreatic iron deposition is a common finding in thalassemia major, being detected in more than one third of patients undergoing their first T2* Magnetic Resonance Imaging scan (MRI) for this purpose. However, no longitudinal studies on pancreatic iron are available in literature. Aim: The aim of this multicenter study was to evaluate the changes in pancreatic iron overload in TM patients enrolled in the Extension-Myocardial Iron Overload in Thalassemia (E-MIOT) Network who performed a baseline and a follow-up (FU) MRI scan at 18 months. Methods. We considered 416 TM patients (37.77±10.46 years; 220 females) consecutively enrolled. Iron overload was quantified by the T2* technique. T2* measurements were performed over pancreatic head, body and tail and global value was the mean. Results. Pancreatic iron overload (global pancreas T2*&lt;26 ms) was detected in 367 (88.2%) patients. Of them, only 14 (3.8%) improved at the FU. Out of the 49 (11.8%) patients without baseline pancreatic iron overload, 15 (30.6%) showed pancreatic iron overload at the FU MRI. A significant inverse association was detected between % change in global pancreas T2*and baseline global pancreas T2* values (R=-0.369; P&lt;0.0001). Patients with baseline pancreatic iron overload showed significantly higher % changes in global pancreas T2* values (see Figure). Changes (%) in global pancreas T2* were not associated with baseline serum ferritin levels or MRI liver iron concentration (LIC) values but were inversely correlated with % changes in serum ferritin levels (R=-0.199; P&lt;0.0001) and % changes in MRI LIC values (R=-0.255; P&lt;0.0001). A significant positive association was found between % changes in global pancreas and global heart T2* values (R=0.133; P=0.007). At baseline MRI, 169 patients showed an alteration of glucidic metabolism: 32 had impaired fasting glucose, 65 impaired glucose tolerance, and 72 diabetes mellitus. These patients showed significantly higher % changes in global pancreas T2* than patients with a normal glucidic metabolism (33.06±79.48% vs 11.93±59.47%; P=0.003). Conclusions. Our data showed that it is difficult to remove the iron from the pancreas and higher improvements were detected in more heavily loaded patients, with alterations of glucidic metabolism. The reduction in pancreatic iron was paralleled by a decrease in hepatic and cardiac iron. Figure 1 Figure 1. Disclosures Pepe: Bayer S.p.A.: Other: no profit support; Chiesi Farmaceutici S.p.A: Other: no profit support. Maggio: Bluebird Bio: Membership on an entity's Board of Directors or advisory committees; Celgene Corp: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees.

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