Iron Sucrose

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Stuart D. Katz - One of the best experts on this subject based on the ideXlab platform.

  • Iron Sucrose augments homocysteine-induced endothelial dysfunction in normal subjects
    Kidney international, 2006
    Co-Authors: H. Zheng, X. Huang, Q. Zhang, Stuart D. Katz
    Abstract:

    Intravenous Iron is commonly used in conjunction with erythropoietic agents to treat anemia in patients with chronic kidney disease. Iron has been proposed to promote oxidative stress and endothelial dysfunction in vascular tissues. We studied the acute effects of intravenous Iron Sucrose on homocysteine-induced endothelial dysfunction in the brachial artery of normal human subjects. In all, 40 healthy subjects received intravenous Iron Sucrose 100 mg or placebo over 30 min immediately before ingestion of 100 mg/kg of oral methionine in a double-blind, randomized study. Flow- and nitroglycerin-mediated dilation in the brachial artery, serum markers of Iron stores, and homocysteine and nitrotyrosine levels were measured before and after study drug administration. Intravenous Iron significantly increased transferrin saturation and non-transferrin-bound Iron (NTBI) when compared with placebo. Flow-mediated dilation significantly decreased from baseline 1 h after administration of Iron Sucrose when compared with placebo (from 6.66±0.47 to 1.93±0.35% after Iron Sucrose vs from 6.00±0.40 to 5.61±0.46% after placebo, P

  • Iron Sucrose augments homocysteine-induced endothelial dysfunction in normal subjects. Commentary
    Kidney International, 2006
    Co-Authors: J. L. Sullivan, H. Zheng, X. Huang, Q. Zhang, Stuart D. Katz
    Abstract:

    Intravenous Iron is commonly used in conjunction with erythropoietic agents to treat anemia in patients with chronic kidney disease. Iron has been proposed to promote oxidative stress and endothelial dysfunction in vascular tissues. We studied the acute effects of intravenous Iron Sucrose on homocysteine-induced endothelial dysfunction in the brachial artery of normal human subjects. In all, 40 healthy subjects received intravenous Iron Sucrose 100 mg or placebo over 30min immediately before ingestion of 100 mg/kg of oral methionine in a double-blind, randomized study. Flow- and nitroglycerin-mediated dilation in the brachial artery, serum markers of Iron stores, and homocysteine and nitrotyrosine levels were measured before and after study drug administration. Intravenous Iron significantly increased transferrin saturation and non-transferrin-bound Iron (NTBI) when compared with placebo. Flow-mediated dilation significantly decreased from baseline 1 h after administration of Iron Sucrose when compared with placebo (from 6.66±0.47 to 1.93±0.35% after Iron Sucrose vs from 6.00±0.40 to 5.61±0.46% after placebo, P

Alan M Brookhart - One of the best experts on this subject based on the ideXlab platform.

  • safety of intravenous Iron in hemodialysis longer term comparisons of Iron Sucrose versus sodium ferric gluconate complex
    American Journal of Kidney Diseases, 2017
    Co-Authors: Wolfgang C Winkelmayer, Benjamin A Goldstein, Aya A Mitani, Victoria Y Ding, Medha Airy, Sreedhar Mandayam, Tara I Chang, Alan M Brookhart, Steven Fishbane
    Abstract:

    Background Controversy exists about any differences in longer-term safety across different intravenous Iron formulations routinely used in hemodialysis (HD) patients. We exploited a natural experiment to compare outcomes of patients initiating HD therapy in facilities that predominantly (in ≥90% of their patients) used Iron Sucrose versus sodium ferric gluconate complex. Study Design Retrospective cohort study of incident HD patients. Setting & Participants Using the US Renal Data System, we hard-matched on geographic region and center characteristics HD facilities predominantly using ferric gluconate with similar ones using Iron Sucrose. Subsequently, incident HD patients were assigned to their facility Iron formulation exposure. Intervention Facility-level use of Iron Sucrose versus ferric gluconate. Outcomes Patients were followed up for mortality from any, cardiovascular, or infectious causes. Medicare-insured patients were followed up for infectious and cardiovascular (stroke or myocardial infarction) hospitalizations and for composite outcomes with the corresponding cause-specific deaths. Measurements HRs. Results We matched 2,015 Iron Sucrose facilities with 2,015 ferric gluconate facilities, in which 51,603 patients (Iron Sucrose, 24,911; ferric gluconate, 26,692) subsequently initiated HD therapy. All recorded patient characteristics were balanced between groups. Over 49,989 person-years, 10,381 deaths (3,908 cardiovascular and 1,209 infectious) occurred. Adjusted all-cause (HR, 0.98; 95% CI, 0.93-1.03), cardiovascular (HR, 0.96; 95% CI, 0.89-1.03), and infectious mortality (HR, 0.98; 95% CI, 0.86-1.13) did not differ between Iron Sucrose and ferric gluconate facilities. Among Medicare beneficiaries, no differences between ferric gluconate and Iron Sucrose facilities were observed in fatal or nonfatal cardiovascular events (HR, 1.01; 95% CI, 0.93-1.09). The composite infectious end point occurred less frequently in Iron Sucrose versus ferric gluconate facilities (HR, 0.92; 95% CI, 0.88-0.96). Limitations Unobserved selection bias from nonrandom treatment assignment. Conclusions Patients initiating HD therapy in facilities almost exclusively using Iron Sucrose versus ferric gluconate had similar longer-term outcomes. However, there was a small decrease in infectious hospitalizations and deaths in patients dialyzing in facilities predominantly using Iron Sucrose. This difference may be due to residual confounding, random chance, or a causal effect.

  • comparative short term safety of sodium ferric gluconate versus Iron Sucrose in hemodialysis patients
    American Journal of Kidney Diseases, 2016
    Co-Authors: Alan M Brookhart, Wolfgang C Winkelmayer, Janet K Freburger, Alan R Ellis, Lily Wang, Abhijit V Kshirsagar
    Abstract:

    Background Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus Iron Sucrose in hemodialysis patients. Study Design Retrospective cohort study using the clinical database of a large dialysis provider (2004-2005) merged with administrative data from the US Renal Data System. Setting & Participants 66,207 patients with Medicare coverage who received center-based hemodialysis. Predictors Iron formulation use assessed during repeated 1-month exposure periods (n=278,357). Outcomes All-cause mortality, infection-related hospitalizations and mortality, and cardiovascular-related hospitalizations and mortality occurring during a 3-month follow-up period. Measurements For all outcomes, we estimated 90-day risk differences between the formulations using propensity score weighting of Kaplan-Meier functions, which controlled for a wide range of demographic, clinical, and laboratory variables. Risk differences were also estimated within various clinically important subgroups. Results Ferric gluconate was administered in 11.4%; Iron Sucrose, in 48.9%; and no Iron in 39.7% of the periods. Risks for most study outcomes did not differ between ferric gluconate and Iron Sucrose; however, among patients with a hemodialysis catheter, use of ferric gluconate was associated with a slightly decreased risk for both infection-related death (risk difference, −0.3%; 95% CI, −0.5% to 0.0%) and infection-related hospitalization (risk difference, −1.5%; 95% CI, −2.3% to −0.6%). Bolus dosing was associated with an increase in infection-related events among both ferric gluconate and Iron Sucrose users. Limitations Residual confounding and outcome measurement error. Conclusions Overall, the 2 Iron formulations studied exhibited similar safety profiles; however, ferric gluconate was associated with a slightly decreased risk for infection-related outcomes compared to Iron Sucrose among patients with a hemodialysis catheter. These associations should be explored further using other data or study designs.

Wolfgang C Winkelmayer - One of the best experts on this subject based on the ideXlab platform.

  • safety of intravenous Iron in hemodialysis longer term comparisons of Iron Sucrose versus sodium ferric gluconate complex
    American Journal of Kidney Diseases, 2017
    Co-Authors: Wolfgang C Winkelmayer, Benjamin A Goldstein, Aya A Mitani, Victoria Y Ding, Medha Airy, Sreedhar Mandayam, Tara I Chang, Alan M Brookhart, Steven Fishbane
    Abstract:

    Background Controversy exists about any differences in longer-term safety across different intravenous Iron formulations routinely used in hemodialysis (HD) patients. We exploited a natural experiment to compare outcomes of patients initiating HD therapy in facilities that predominantly (in ≥90% of their patients) used Iron Sucrose versus sodium ferric gluconate complex. Study Design Retrospective cohort study of incident HD patients. Setting & Participants Using the US Renal Data System, we hard-matched on geographic region and center characteristics HD facilities predominantly using ferric gluconate with similar ones using Iron Sucrose. Subsequently, incident HD patients were assigned to their facility Iron formulation exposure. Intervention Facility-level use of Iron Sucrose versus ferric gluconate. Outcomes Patients were followed up for mortality from any, cardiovascular, or infectious causes. Medicare-insured patients were followed up for infectious and cardiovascular (stroke or myocardial infarction) hospitalizations and for composite outcomes with the corresponding cause-specific deaths. Measurements HRs. Results We matched 2,015 Iron Sucrose facilities with 2,015 ferric gluconate facilities, in which 51,603 patients (Iron Sucrose, 24,911; ferric gluconate, 26,692) subsequently initiated HD therapy. All recorded patient characteristics were balanced between groups. Over 49,989 person-years, 10,381 deaths (3,908 cardiovascular and 1,209 infectious) occurred. Adjusted all-cause (HR, 0.98; 95% CI, 0.93-1.03), cardiovascular (HR, 0.96; 95% CI, 0.89-1.03), and infectious mortality (HR, 0.98; 95% CI, 0.86-1.13) did not differ between Iron Sucrose and ferric gluconate facilities. Among Medicare beneficiaries, no differences between ferric gluconate and Iron Sucrose facilities were observed in fatal or nonfatal cardiovascular events (HR, 1.01; 95% CI, 0.93-1.09). The composite infectious end point occurred less frequently in Iron Sucrose versus ferric gluconate facilities (HR, 0.92; 95% CI, 0.88-0.96). Limitations Unobserved selection bias from nonrandom treatment assignment. Conclusions Patients initiating HD therapy in facilities almost exclusively using Iron Sucrose versus ferric gluconate had similar longer-term outcomes. However, there was a small decrease in infectious hospitalizations and deaths in patients dialyzing in facilities predominantly using Iron Sucrose. This difference may be due to residual confounding, random chance, or a causal effect.

  • comparative short term safety of sodium ferric gluconate versus Iron Sucrose in hemodialysis patients
    American Journal of Kidney Diseases, 2016
    Co-Authors: Alan M Brookhart, Wolfgang C Winkelmayer, Janet K Freburger, Alan R Ellis, Lily Wang, Abhijit V Kshirsagar
    Abstract:

    Background Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus Iron Sucrose in hemodialysis patients. Study Design Retrospective cohort study using the clinical database of a large dialysis provider (2004-2005) merged with administrative data from the US Renal Data System. Setting & Participants 66,207 patients with Medicare coverage who received center-based hemodialysis. Predictors Iron formulation use assessed during repeated 1-month exposure periods (n=278,357). Outcomes All-cause mortality, infection-related hospitalizations and mortality, and cardiovascular-related hospitalizations and mortality occurring during a 3-month follow-up period. Measurements For all outcomes, we estimated 90-day risk differences between the formulations using propensity score weighting of Kaplan-Meier functions, which controlled for a wide range of demographic, clinical, and laboratory variables. Risk differences were also estimated within various clinically important subgroups. Results Ferric gluconate was administered in 11.4%; Iron Sucrose, in 48.9%; and no Iron in 39.7% of the periods. Risks for most study outcomes did not differ between ferric gluconate and Iron Sucrose; however, among patients with a hemodialysis catheter, use of ferric gluconate was associated with a slightly decreased risk for both infection-related death (risk difference, −0.3%; 95% CI, −0.5% to 0.0%) and infection-related hospitalization (risk difference, −1.5%; 95% CI, −2.3% to −0.6%). Bolus dosing was associated with an increase in infection-related events among both ferric gluconate and Iron Sucrose users. Limitations Residual confounding and outcome measurement error. Conclusions Overall, the 2 Iron formulations studied exhibited similar safety profiles; however, ferric gluconate was associated with a slightly decreased risk for infection-related outcomes compared to Iron Sucrose among patients with a hemodialysis catheter. These associations should be explored further using other data or study designs.

Deng Yinghu - One of the best experts on this subject based on the ideXlab platform.

  • Influence of intravenous Iron Sucrose on restless legs syndrome in hemodialysis patients
    Journal of Shanxi Medical University, 2014
    Co-Authors: Deng Yinghu
    Abstract:

    Objective To explore the influence of intravenous Iron Sucrose on restless legs syndrome( RLS) in hemodialysis patients.Methods Thirty-two maintenance hemodialysis patients with RLS were divided into control group and study group.The patients were given maintenance hemodialysis in control group and intravenous Iron Sucrose 1 000 mg in study group.Two weeks after treatment,the score of international RLS rating scale for severity( IRLSSGRS),serum ferritin( SF) and transferrin saturation( TSAT) were detected.Results Two weeks after treatment,the IRLSSGRS score,SF and TSAT levels were not changed significantly in control group( P 0.05).In study group,the IRLSSGRS score reduced( P 0.01) and was lower than in control group( P 0.01).The SF and TSAT levels increased( P 0.01),and were higher than in control group( P 0.01).Conclusion The intravenous Iron Sucrose appears to be an effective therapy for RLS in hemodialysis patients.

Margarita Angerosa - One of the best experts on this subject based on the ideXlab platform.

  • Nitrosative stress and apoptosis in non-anemic healthy rats induced by intravenous Iron Sucrose similars versus Iron Sucrose originator
    BioMetals, 2015
    Co-Authors: Jorge E. Toblli, Margarita Angerosa
    Abstract:

    Iron can both induce and inhibit nitrosative stress. Intracellular Iron levels play an important role in nitric oxide (NO^•) signaling mechanisms. Depending on various factors, such as the cell’s redox state and transition metal levels, NO^• generation may lead to lipid peroxidation and DNA damage as well as both anti- and pro-apoptotic effects. Administration of intravenous Iron Sucrose originator (IS_ORIG) has been shown not to cause significant tyrosine nitration or significantly increased caspase 3 levels in non-anemic rats. In this study, the potential of several marketed Iron Sucrose similars (ISSs) to induce tyrosine nitration and caspase 3 expression in non-anemic rats was assessed. Although the physico-chemical properties of most of the analyzed ISSs complied with the United States Pharmacopeia for Iron Sucrose injection, all ISSs resulted in higher levels of tyrosine nitration and increased the expression of caspase 3 versus IS_ORIG. Moreover, significant differences were detected in tissue Iron distribution between IS_ORIG- and ISS-treated animals. In general, IS_ORIG resulted in higher levels of ferritin deposits versus ISSs whereas ISSs showed higher Prussian blue-stainable Iron(III) deposits than IS_ORIG. This result suggests that some Iron from ISSs bypassed the tightly regulated pathway through resident macrophages of the liver, spleen and bone marrow thus, ending up in the cellular compartment that favors oxidative and or nitrosative stress as well as apoptosis. The results also confirm that polynuclear Iron(III)-oxyhydroxide carbohydrates, such as Iron Sucrose, cannot be fully characterized by physico-chemical methods alone.

  • Differences Between Original Intravenous Iron Sucrose and Iron Sucrose Similar Preparations
    Arzneimittel-Forschung, 2011
    Co-Authors: Jorge E. Toblli, Gabriel Cao, Leda Oliveri, Margarita Angerosa
    Abstract:

    Iron Sucrose (Venofer; reference) has a good safety record and is prescribed in patients with anaemia and chronic kidney disease worldwide, but various Iron Sucrose similar (ISS) preparations are now utilized in clinical practice. This study evaluates possible differences between Iron Sucrose and ISS preparations on haemodynamic and oxidative stress markers in normal rats. 60 male and 60 female Sprague Dawley rats were divided into four groups and assigned to receive commercially available ISS test 1, ISS test 2, reference or isotonic saline solution (control). A single i.v. dose of Iron (40 mg/kg) or saline (equivalent volume) was administered after 24 h and every 7 days for 4 weeks. Blood samples were collected for biological assessment of haemoglobin (Hb), serum Iron and percentage transferrin saturation (TSAT), and urine samples were collected to investigate creatinine clearance and proteinuria. Animals were sacrificed after receiving an i.v. dose on days 1, 7 and 28, and kidney, liver, and heart homogenates were then collected to determine antioxidant enzyme levels. Tissues were processed using Prussian blue and immmunohistochemistry techniques to identify Iron deposits, tissue ferritin and pro-inflammatory markers. Systolic blood pressure was significantly reduced in the ISS groups relative to the reference and control groups after 24 h and on days 7, 14 and 21 (p < 0.05). Creatinine clearance was reduced (p < 0.01) and proteinuria marked (p < 0.01) in the ISS groups at 24 h and on days 7 and 28 relative to the reference and control groups which did not differ throughout the study. Liver enzymes were also increased in the ISS groups at 24 h and on days 7 and 28. Both ISS test 1 and ISS test 2 groups presented a significant increase in catalase, thiobarbituric reactive species, Cu, Zn-superoxide dismutase (CuZnSOD) and glutathione peroxidase activity, and a decrease in glutathione levels (p < 0.01) in the liver, heart and kidney at 24 h and on day 7 relative to the reference and control groups. Serum Iron and percentage TSAT were elevated in all groups (except control) (p < 0.01) but no differences in Hb concentration were observed between them. Finally, levels of the proinflammatory markers TNF-alpha and IL6 were significantly elevated in the ISS groups (liver, heart and kidney) compared with the reference and control groups on day 28 (p < 0.01). These findings suggest significant differences between the reference and ISS test 1/ISS test 2 regarding oxidative stress and the inflammatory responses of liver, heart and kidneys in normal rats. A possible explanation for these observations could be the stability of the Iron complex.