Serum Ferritin Levels In Patients Research Articles

The association between triglyceride-glucose index and hyperferritinemia in patients with type 2 diabetes mellitus.

To investigate the relationship between the triglyceride-glucose (TyG) index and serum ferritin (SF) levels in patients with type 2 diabetes mellitus (T2DM). A total of 881 T2DM patients were divided into T1(TyG index < 1.66), T2 (1.66 ≤ TyG index < 2.21), and T3 (TyG index ≥ 2.21) groups according to the tertiles of the TyG index. The differences in SF levels and the prevalence of hyperferritinemia (SF ≥ 300ng/mL for male or SF ≥ 150ng/mL for female) were compared. The independent correlations between the TyG index and SF, and between hyperferritinemia and TyG in T2DM patients were analyzed, respectively. SF levels in male T2DM patients were higher in the T3 group (250.12ng/mL) than in the T1 and T2 groups (180.45 and 196.56ng/mL, both p < 0.01),while in female patients with T2DM,SF levels were higher in the T3 group (157.25ng/mL) than in the T1 group (111.06ng/mL, p < 0.05).The prevalence of hyperferritinemia in male T2DM patients was higher in the T3 group (31.3%) than those in the T1 and T2 groups (10.4% and 17.3%, both p < 0.05).The TyG index was positively correlated with SF levels in T2DM patients (R = 0.178, p < 0.001).TyG index was independently and positively correlated with SF levels after adjusting for confounders (β = 0.097, 95%CI [2.870,38.148], p = 0.023).The TyG index was positively independently correlated with hyperferritinemia in male T2DM patients (OR = 1.651, 95%CI [1.120,2.432], p = 0.011). In parallel with increasing TyG index SF levels gradually increased. The TyG index was positively correlated with SF levels in patients with T2DM and was positively correlated with hyperferritinemia in male T2DM patients.

SERUM FERRITIN LEVEL IN PATIENTS WITH ACUTE HAEMORRAGIC STROKE AND ITS ASSOCIATION WITH OUTCOME

Background:Stroke is characterized by acute onset of focal neurological deficit lasting 24 hours or longer. With the increasing incidence of hemorrhagic stroke in Indians, the use of biochemical markers like Ferritin can predict outcome. This study was undertaken to study level of Serum Ferritin levels in patients with acute hemorrhagic stroke and it association with the outcome. Materials and Methods: This was a hospital based cross sectional observational study with 90 patients with acute hemorrhagic stroke admitted into the Department of Medicine, JMCH since 1st July 2020 till June 30th 2021. All the patients subjected to investigations and inclusion and exclusion criteria. Equal number of age and sex matched healthy individuals were included in the study as control Results: In this study the mean age group with Acute Hemorrhagic Stroke was 63.3 +-7.2 years. Of the total cases 57 were males (63.3%) and 33 female (37.7%). Hypertension was the most common risk factor associated present in 67.8% patients which is 53.3. The most common site of bleed was the basal ganglia. The mean serum Ferritin value was 333.44 +92.12ng/ml in patients with acute hemorrhagic stroke .The serum ferritin values correlated with the hematoma volume and higher values were associated with increased mortality . Conclusion: In the study Serum Ferritin values were significantly higher 445.29+-97.70 ng/ml (p value&lt;.001) in patients which deteriorated and showed a positive correlation.

SERUM FERRITIN LEVEL IN PATIENTS WITH ACUTE HAEMORRAGIC STROKE AND ITS ASSOCIATION WITH OUTCOME

SERUM FERRITIN LEVEL IN PATIENTS WITH ACUTE HAEMORRAGIC STROKE AND ITS ASSOCIATION WITH OUTCOME

Predicting Serum Ferritin Levels in Patients with Iron Overload Treated with the Film-Coated Tablet of Deferasirox during the Eclipse Study

Background: The ECLIPSE trial demonstrated that the new film-coated tablet (FCT) deferasirox (DFX) formulation and the dispersible tablet (DT) had similar safety profiles during 6 months of treatment, although fewer patients experienced severe gastrointestinal-related adverse events, and more patients experienced favorable patient-reported outcomes with FCT than with DT (Taher et al. Am J Hematol 2017). Additionally, FCT patients had a greater reduction in serum ferritin (SF) levels from baseline to end of treatment (geometric mean change −431 vs −153 ng/mL in DT patients) despite both groups experiencing similar DFX exposure, which suggests greater efficacy with FCT. In the absence of FCT efficacy data beyond 6 months, we developed a model to predict SF levels in patients from the ECLIPSE trial if they had continued DFX DT or FCT treatment for 6-12 months.Methods: ECLIPSE was a Phase II, randomized, open-label study in which patients with transfusion-dependent thalassemia (TDT) or International Prognostic Scoring System lower-risk myelodysplastic syndromes (MDS) were randomized to receive DFX DT or FCT. Planned doses in iron chelation therapy (ICT)-naïve patients were DT 20 mg/kg/day or FCT 14 mg/kg/day based on equivalent FCT doses being 30% lower than DT due to improved bioavailability. ICT pre-treated patients received either a DT dose equivalent to their pre-washout dose or a planned 30% reduction for FCT. Dose was adjusted based on SF levels and investigator's judgment every 4 weeks for ICT-naïve patients and every 3 months for ICT pre-treated patients (DT ±5-10 mg/kg/day, max 40 mg/kg/day; FCT ±3.5-7 mg/kg/day, max 28 mg/kg/day); dose adjustments for safety reasons were permitted at any time.Models for predicting ICT effect were built and tested based on 12-month data from the controlled registration study ICL670A108 (Porter et al. Eur J Haematol 2008). Most patients from ECLIPSE had received prior ICT; therefore, for the development of the model, this situation was mimicked using ICL670A108 month 3-9 data for fitting, and month 10-12 data for evaluating model prediction quality. The selected model accounted for baseline SF levels, assigned daily DFX dose per arm and patients' body weight, and predicted the ICT effect for up to 12 months if patients had continued with their therapy (DT or FCT). The model was applied to both DT and FCT arms of the ECLIPSE trial and predictions were obtained from individual estimates of each patient.Results:Trial results: 173 patients were randomized 1:1 to DT (n=86) or FCT (n=87); 70 patients in each arm had TDT and 16 patients had MDS (underlying disease missing in 1 FCT patient). Mean±SD age was 34.9±19.3 years, 51% were female and 90% had previously received ICT. Mean±SD actual daily DFX dose over 24 weeks was 27.5±7.7 mg/kg/day (DT) and 20.8±5.4 mg/kg/day (FCT). At baseline, SF geometric mean was 2381 ng/mL (DT) and 2721 ng/mL (FCT).Model prediction: Model diagnostics suggested a close approximation of the ECLIPSE data, as the predicted SF geometric mean during the first 6 months of treatment was similar to the actual SF values observed during the trial (Figure). The model predicted that SF geometric mean values would continue to decrease over the subsequent 6 months with both DT and FCT, reaching 2162 ng/mL (90% confidence interval [CI] 2029-2304) with DT and 2180 ng/mL (90% CI 2054-2311) with FCT after 12 months of treatment. This corresponds to a predicted, relative decrease of 10% with DT and 19% with FCT.Conclusions: The 6-month results of the model were similar to the actual SF values observed during the ECLIPSE trial, and reliably predicted continued ICT effect for months 7-12 if patients had continued with their assigned treatment (DT or FCT). Previous analyses have indicated that improved patient-reported outcomes, especially increased adherence, are significant mediators of the association between treatment with DT vs FCT and SF reduction from baseline over 6 months of treatment (Taher et al. Haematologica 2017;102[s2]:abst P286). According to the predicted results from this model, and at the doses given in this study, patients treated with FCT would have had a greater reduction in SF at 12 months compared with patients treated with DT; although it should be noted that FCT patients had higher baseline SF. This analysis suggests the FCT offers patients an improved DFX formulation, which could be attributed to improved treatment adherence. [Display omitted] DisclosuresTaher:Novartis Pharmaceuticals: Honoraria, Research Funding; Celgene: Research Funding. Weber:Novartis: Employment. Han:Novartis: Employment. Bruederle:Novartis: Employment. Porter:Celegene: Consultancy; Agios Pharmaceuticals: Consultancy, Honoraria; Shire: Consultancy, Honoraria; Bluebird Bio: Consultancy; Novartis: Consultancy, Honoraria, Research Funding.

Reviewing EKGs in Thalassemia Patients to Evaluate Their Cardiac Function

Introduction: There are more than 18000 thalassemia patients in Iran. In a current study, a high rate of mortality in these patients due to heart failure, is shown. Main factors for evaluating this disorder in thalassemia patients were their electrocardiograms (EKGs) and Serum Ferritin Levels (SFLs). Methods: We studied the cardiac function in 91 patients (73 major and 18 intermediate thalassemia patients) treated in Zafar Thalassemia Center, of whom 35 (38.45%) were male and 56 (61.55%) were female. The Factors in this study contains: EKGs, mean annual serum ferritin (at least, three SFL had been recorded in each patient treatment file in 2009), mean annual hemoglobin (Hb) levels and mean annual hematocrit (Hct) levels (average, 12 recorded hematocrit levels during 2009). Results: Our findings have shown that Q-T interval did not correlate with ferritin (r = 0.05, P > 0.05). In both patients with LVH and without LVH, there was no significant difference in SFL (P > 0.05). Although, the mean rate among the thalassemia patients was 85.34 ± 12.91, it did not correlate significantly with QRS duration and P-R Interval (r = -0.08, P > 0.05). In addition, ferritin did not correlate significantly with QRS duration and P-R Interval (r = 0.1, r = 0.05 and P > 0.05, P > 0.05). Furthermore, there was no difference in SFL in patients with normal cardiac axis and those with cardiac axis deviation. Conclusion: There is no correlation between SFL and variations in EKG. Although EKG is an available method for checking cardiac function in thalassemic patients, especially in developing countries, physicians cannot rely on it for diagnosis or prognosis of cardiac failure in thalassemia patients. Therefore, other methods such as MRIT2* and Echocardiography are suggested to be used periodically in order to check the cardiac function in thalassemia patients.

Value of serum ferritin in measuring the activation and prognosis in systemic onset juvenile idiopathic arthritis

To explore the correlation of serum ferritin (SF) and systemic onset juvenile idiopathic arthritis (SOJIA) so as to determine the prognostic values of SF for SOJIA. All samples were collected from 92 juvenile idiopathic arthritis (JIA) patients at Beijing Children's Hospital between February 2005 to September 2012. Their age range was 2-15 years. There were macrophage activation syndrome (MAS, n = 25), polyarticular JIA (n = 33) and oligoarticular JIA (n = 30). And 47 healthy children and another 30 with acute infective diseases were selected as control groups respectively. Blood samples were collected and SF was measured in different disease phases.Other parameters include leucocyte, hemoglobin, platelet, C-reactive protein and erythrocyte sedimentation rate.Statistics of SF level at different groups as well as at different disease phases were performed. The SF level of active phase SOJIA patients was significantly higher (P < 0.01) than that in Other groups. And its level in the active phase of SOJIA was significantly higher than that in patients during the recovery phase. The SF level in patients with MAS was significantly higher than that in those without MAS. Correlated with the course of SOJIA, the level of SF may judge the disease activity and predict the outcomes of SOJIA.

Long-Term Safety and Efficacy of Deferasirox (Exjade®) In Transfused Patients with Sickle Cell Disease Treated for up to 5 Years

AbstractAbstract 845 Background:Transfusion therapy can effectively treat many complications associated with sickle cell disease (SCD), but iron overload will develop without iron chelation therapy. Despite long-term transfusion requirements, long-term data for iron chelation in SCD are limited. The oral iron chelator, deferasirox, effectively reduced iron burden in SCD patients aged ≥2 years during 1 year of treatment (Vichinsky et al. Br J Haematol 2007). This 5-year follow-up is the first report of long-term deferasirox treatment in SCD patients. Methods:Eligible patients that completed the 1-year core study (randomized to deferasirox [deferasirox cohort] or deferoxamine [crossover cohort]) entered the 4- year extension. All received deferasirox while continuing their regular transfusion regimen. Deferasirox dose in the extension was initially based on serum ferritin (SF) trends in the core study (deferasirox cohort) or transfusion requirements (crossover cohort). Dose adjustments were based on monthly SF and safety assessments (investigator-reported adverse events [AEs] and centrally processed lab parameters). Growth and sexual development (Tanner staging) were assessed annually. Results:Of the patients in the deferasirox (n=132) and crossover (n=53) cohorts that received '1 deferasirox dose during the core or extension, 43 (33%) and 19 (36%) patients, respectively, completed the extension. Reasons for discontinuation included withdrawal of consent (n=44, 23.8%), loss to follow-up (n=17, 9.2%) and AEs (n=14, 7.6%). Three deaths occurred, all in the extension (intraventricular hemorrhage, n=2; intracranial bleed post liver transplantation, n=1); none considered by investigators to be deferasirox-related. Mean dose during the study was 18.7 ± 6.5 and 21.2 ± 5.3 mg/kg/day in the deferasirox and crossover cohorts, respectively. Investigator-assessed drug-related AEs (≥5% overall) included nausea (14.6%), diarrhea (10.8%), increased blood creatinine (5.9%) and vomiting (5.4%). Generally, these AEs were manageable and transient, and decreased in frequency over time. Serious AEs were reported in 70.8% of patients overall and were mostly related to the underlying disease. Serious investigator-assessed drug-related AEs were reported in 8 patients (6.1%) in the deferasirox cohort and 1 patient (1.9%) in the crossover cohort. In the deferasirox and crossover cohorts respectively, 9 (6.8%) patients and 1 (1.9%) patient had 2 consecutive serum creatinine level increases >33% above baseline and >upper limit of normal (ULN). Median creatinine clearance remained stable within normal range throughout the study. One patient from each cohort had alanine aminotransferase (ALT) >10 × ULN on 2 consecutive visits; both had ALT values ≤ULN at the start of deferasirox treatment. In 37 patients with data available before and after dose increases to ≥30 mg/kg/day, no clinically relevant differences were observed in AE profile or laboratory parameters before and after dose increase. Deferasirox had no adverse effect on pediatric growth and adolescent sexual development. Overall, median SF levels in patients who received deferasirox treatment for ≥4 years decreased significantly from 3410 to 3108 ng/mL at end of study (median absolute change, –591 ng/mL, P=0.027; n=67). Decreases in SF were more pronounced when mean deferasirox dose increased to >20 mg/kg/day (Figure 1). In the deferasirox cohort, the median absolute change in SF levels from start of deferasirox to end-of-study was greater in patients aged ≥16 than 2–<16 years (–476 vs –156 ng/mL) reflecting low 1st-year deferasirox doses and conservative dose escalation in pediatric patients. Conclusions:This is the first study to report that deferasirox can significantly decrease SF levels over the long-term in SCD patients without evidence of renal toxicity. Treatment for up to 5 years was associated with a clinically manageable safety profile, without progressive decreases in median creatinine clearance, which remained within normal range. The modest, but statistically significant, decrease in SF is most likely due to under-dosing in the first 2 years and variability in SF related to disease factors. Patients titrated to an appropriate dose had a clinically relevant decrease in SF, highlighting the need to adjust dose, usually to >20 mg/kg/day, to achieve negative iron balance. [Display omitted] Disclosures:Vichinsky:Novartis: Consultancy, Research Funding, Speakers Bureau; Apotex: Consultancy, Research Funding; Hemaquest: Consultancy, Membership on an entity's Board of Directors or advisory committees. Bernaudin:Novartis: Investigator for SCD deferasirox (Exjade). Forni:Novartis: Research Funding. Gardner:Novartis: Research Funding. Hassell:Novartis: Research Funding. Heeney:Novartis: Research Funding. Kutlar:Novartis: Research Funding. Lane:Novartis: Research Funding. Mathias:Novartis: Research Funding. Porter:Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Tebbi:Novartis: Speakers Bureau. Wilson:Novartis: Honoraria, Research Funding, Speakers Bureau. Griffel:Novartis: Employment. Deng:Novartis: Employment. Giannone:Novartis: Employment. Coates:Novartis: Research Funding, Speakers Bureau.

Long-Term Treatment with Deferasirox (Exjade®, ICL670), a Once-Daily Oral Iron Chelator, Is Effective in Patients with Transfusion-Dependent Anemias.

Background: The efficacy and safety of deferasirox was established during five 1-year core trials. As many patients will require lifelong chelation therapy, assessing long-term efficacy and safety is important. In the core trials, initial doses were assigned by baseline liver iron concentration (LIC). A clear dose response was observed: 5/10 mg/kg/d doses were generally insufficient to balance iron intake from ongoing transfusions, while 20 and 30 mg/kg/d maintained or reduced iron balance, respectively. This analysis evaluates serum ferritin (SF) levels and cumulative safety data during 4-year extension trials.Methods: In the extensions, dose modifications were based on safety and efficacy parameters. Safety and SF were assessed monthly. Due to methodological differences in study 105, the SF data from this trial are not included in this analysis.Results: 1034 patients with β-thalassemia (n=750), sickle cell disease (n=185), MDS (n=47) and other anemias (n=52) have received deferasirox. 703 patients received deferasirox in the core trials and have been on treatment for a median of 3.4 years; 331 crossed over to deferasirox in the extensions. 210 (20%) patients have discontinued treatment due to: AEs (74), consent withdrawal (64), unsatisfactory therapeutic effect (29) and other (43). Only 17 (1.6%) patients have discontinued in the past 12 months (9 AEs; 1 death; 4 lost to follow-up; 2 withdrew consent; 1 other). 16 patients have died, 6 in the core and 10 in the extensions. 5 patients (4 β-thalassemia, 1 sideroblastic anemia) aged 18-24 years with inadequate chelation and severe iron overload before study entry died with cardiac failure in the extensions. Other deaths were due to other complications/progression of the underlying disease. At month 42, mean (SD) dose in the 5/10, 20 and 30 mg/kg/d dose groups was 21.8 (9.3), 23.2 (8.2) and 25.4 (9.8) mg/kg/d, respectively. Median SF levels (ng/mL) are shown in the Table (n=652, deferasirox cohort only).Drug-related AEs during deferasirox treatment were generally transient, of mild/moderate severity, and showed a reduction in frequency from the core trials. No patient has developed progressive increases in serum creatinine or values >2 x ULN. 2 patients discontinued due to stable creatinine increases of 1.5 x ULN and confounding circumstances (concomitant cyclosporine and multiple infections, respectively). 1 patient discontinued due to recurrent episodes of proteinuria. 12 patients discontinued due to increases in transaminases (4 core study, 8 extension [3 crossover patients]). Drug-induced liver toxicity was likely in 2 patients with early onset and positive rechallenge. Increasing LIC due to under-chelation was the likely explanation in at least some patients.Conclusions: Over 3.5 years' treatment, deferasirox 20/30 mg/kg/d maintained/reduced SF levels in patients with various transfusion-dependent anemias. There was no increase in frequency of drug-related AEs or changes in markers of liver or renal function that differed significantly from the 1-year core trials.Initial dose, mg/kg/dMonth5/10 (n=227)20 (n=182)30 (n=243)Baseline20512375373412*265021612649242481250822713614391844207142134516672025*Dose adjustments

Association between serum ferritin and the insulin resistance syndrome in a representative population

Unexplained hepatic iron overload with increased serum ferritin (SF) values has been associated with the insulin resistance syndrome (IRS), defined by the presence of one or more of the following criteria: increased body mass index (BMI), diabetes, hyperlipidemia or hypertension. However, as yet the association between IRS and SF in a representative population has not been investigated. The study subjects participated in a nationwide epidemiological survey on metabolic disorders in the adult German population. The 1200 probands included in this study are representative of the German population. To eliminate major causes of secondary iron overload, 114 (9.5%) subjects with excessive alcohol consumption and 16 (1.5%) subjects with serological evidence for hepatitis B or C were excluded. For all remaining 1070 probands, complete clinical data of SF, HbA1c, known diabetes, BMI, cholesterol, high-density lipoprotein-cholesterol and blood pressure were available. SF values were significantly increased in men and women with high BMI (> 25 kg/m2), increased cholesterol (> 200 mg/dl), and increased systolic (> 160 mmHg) blood pressure, in women with diabetes, and in men with increased diastolic (> 95 mmHg) blood pressure. Furthermore, there was a significant correlation between the number of IRS criteria and SF. This study shows a significant correlation between SF and the presence of IRS criteria in a large representative population. Interestingly, the severity of the IRS seems to be associated with increased SF levels suggesting a causal connection. Further studies are required to investigate the pathophysiological mechanism and consequences of increased SF levels in patients with IRS.

Risk of iron overload and 'hemochromatosis allele(s)' in patients on maintenance hemodialysis.

In the present study, we have evaluated the relationship between serum ferritin (SF) levels, 'hemochromatosis allele(s)', blood transfusions and iron parenteral administration in 69 hemodialysis patients. We demonstrated significantly higher SF levels in patients with hemochromatosis allele(s) (HA+) than in patients without hemochromatosis alleles (HA-). In addition, HA+ patients who had received blood transfusions up to 15 months prior to the study had SF levels even higher than those without blood transfusions. On the other hand, HA- patients had normal levels of SF, independent of blood transfusions. After intravenous administration of 1 g iron saccharate, SF levels were significantly higher only in HA+ transfused patients. In conclusion, our study demonstrated that HA+ patients are at a higher risk of iron overload and therefore the use of transfusional and/or parenteral iron should be strictly limited.