Safety and Usefulness of Intravenous Iron Sucrose in the Management of Preoperative Anemia in Patients with Menorrhagia: A Phase IV, Open-Label, Prospective, Randomized Study The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial. Intravenous Iron Sucrose in Peritoneal Dialysis Patients with Renal Anemia A comparison of oral and intravenous iron supplementation in preterm infants receiving recombinant erythropoietin. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Postoperative intravenous iron used alone or in combination with low-dose erythropoietin is not effective for correction of anemia after cardiac surgery. A Randomized Controlled Trial of Intravenous or Oral Iron for Posttransplant Anemia in Kidney Transplantation The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery Intravenous versus oral iron supplementation for preoperative stimulation of hemoglobin synthesis using recombinant human erythropoietin. Efficacy of IV iron compared to oral iron for increment of haemoglobin level in anemic chronic kidney disease patients on erythropoietin therapy. Intravenous iron increases labile serum iron but does not impair forearm blood flow reactivity in dialysis patients. Intravenous iron supplementation for the treatment of anaemia in pre-dialyzed chronic renal failure patients.
Background : The aim of this study was to compare the efficacy , safety and achievement of the target hemoglobin level ( Hb ≥10 g/dl ) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management . Methods : Seventy-six patients with Hb levels < 9.0 g/dl who were scheduled to undergo surgical treatment were r and omized to receive either intravenous iron sucrose ( based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week , beginning 3 weeks before surgery ) or oral iron ( 80 mg/day of oral iron protein succinylate daily ) . Results : The intravenous iron group had higher increases in Hb ( 3.0 vs. 0.8 g/dl ; p < 0.0001 ) and ferritin levels ( 170.1 vs. 4.1 μg/l ; p < 0.0001 ) than the oral iron group . Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group ( 76.7 vs. 11.5 % ; p < 0.0001 ) . There were tolerable adverse events in both groups . Conclusion : Preoperative intravenous iron sucrose administration is more effective  than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia OBJECTIVES Anaemia is a frequent complication after cardiopulmonary bypass surgery .  Iron therapy has been variably employed by medical centres over the years . In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia , and its impact on blood transfusion requirements , in patients undergoing cardiopulmonary bypass surgery . METHODS A double-blind , r and omized , placebo-controlled clinical trial with three parallel groups of patients . Group I ( n = 54 ) : intravenous iron(III)-hydroxide sucrose complex , three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge . Group II ( n = 53 ) : oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge , and intravenous placebo while hospitalized . Group III ( n = 52 ) : oral and intravenous placebo pre- and postoperatively , following the same protocol . Data were collected preoperatively , at theatre , at intensive care unit admission , before hospital discharge and 1 month later . RESULTS ( 1 ) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups ; ( 2 ) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period ; ( 3 ) the intravenous iron group showed higher serum ferritin levels at hospital discharge ( 1321 ± 495 ng/ml ; P < 0.001 ) and 1 month later ( 610 ± 387 ; P < 0.001 ) compared with the other groups and ( 4 ) we did not observe statistical differences in blood transfusion requirements between the three groups . CONCLUSIONS The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements . [ Current Controlled Trials number : NCT01078818 ( oral and intravenous iron in patients postoperative cardiovascular surgery under EC ) ] Objective To explore the safety and efficacy of intravenous ( IV ) iron sucrose in maintenance peritoneal dialysis ( PD ) . Design R and omized , controlled , parallel-group single-center trial . Setting Blood Purification Center of Chaoyang , Beijing Capital University of Medical Science , China . Methods 46 patients on PD were involved in this trial . 26 patients received IV iron sucrose ( 200 mg iron ) once per week for 4 weeks then once every other week for a further 4 weeks . The other 20 patients received oral ferrous succinate , 200 mg three times per day , for 8 weeks . Hemoglobin , hematocrit , serum ferritin ( SF ) level , and transferrin saturation ( TSAT ) were assessed at baseline and then again after 2 , 4 , and 8 weeks of treatment . Results There were no differences between the IV and oral groups in terms of sex , age , duration of PD , mean dialysate dosage per day , erythropoietin dosage per week , or hematological parameters at baseline . After 4 and 8 weeks of treatment , mean Hb and Hct were significantly increased in the IV group and were also significantly higher than those in the oral group . Levels of SF and TSAT were also significantly increased in the IV group , and significantly higher than in the oral group . After 8 weeks , the response rate in the IV group was 94.8 % , which was significantly higher than that in the oral group . The mean erythropoietin dose was significantly lower in the IV group than in the oral group . Hb , Hct , SF , and TSAT levels were maintained between 4 and 8 weeks in the IV group despite the decrease in dose frequency . There were no adverse events with IV iron . Eight patients in the oral group had adverse gastrointestinal effects . Conclusion IV iron sucrose is safe in PD patients . It increases Hb levels and serum iron parameters more effectively than oral iron ; it is well tolerated and can permit reductions in the required dose of erythropoietin OBJECTIVE To determine whether intravenously administered iron supplements would improve the hematologic response to recombinant erythropoietin  in stable preterm infants . METHODS Forty-two preterm infants ( <33 weeks ' gestation , birth weight < 1500 gm , hematocrit < 38 % ) were treated with recombinant human erythropoietin ( Eprex ) , 600 U/kg per week , and r and omly assigned to receive either an oral preparation of ferrous lactate ( elemental iron , 12 mg/kg per day ) or an intravenous preparation of iron sucrose ( 6 mg/kg per week ) . RESULTS Hematocrits , reticulocyte counts , and transfusions were similar in the oral group ( OG ) and the intravenous group ( IVG ) . However , markedly higher serum ferritin concentrations were noted in the IVG ( p < 0.001 ) , and by completion of the study the arithmetic mean values were 265 + /- 127 microg/L versus 137 + /- 65 microg/L in the IVG and the OG , respectively . The numbers of hypochromic erythrocytes increased in both groups during the study but were significantly higher in the OG ( p = 0.04 ) . Mean daily weight gain in the IVG ( 27 + /- 6.4 gm/day ) was greater than in the OG ( 22.9 + /- 4.78 gm/day ; p = 0.04 ) . CONCLUSIONS High doses of both orally administered iron and intravenously administered iron sucrose appear to supply sufficient iron for erythropoiesis in stable infants . Storage iron may become depleted after oral supplementation . The intravenous preparation appears to be safe and maintains serum ferritin concentrations , and it may be indicated for patients with low ferritin levels and for those not established on enteral feedings PURPOSE The concomitant use of intravenous ( IV ) iron as a supplement to erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia is controversial . This study was design ed to evaluate the efficacy and safety of darbepoetin alpha given with IV iron versus with local st and ard practice ( oral iron or no iron ) . PATIENTS AND METHODS In this multicenter , r and omized , open-label , phase III study , 396 patients with nonmyeloid malignancies and hemoglobin ( Hb ) less than 11 g/dL received darbepoetin alpha 500 microg with ( n = 200 ) or without ( n = 196 ) IV iron once every 3 weeks ( Q3W ) for 16 weeks . RESULTS The hematopoietic response rate ( proportion of patients achieving Hb > or= 12 g/dL or Hb increase of > or= 2 g/dL from baseline ) was significantly higher in the IV iron group : 86 % versus 73 % in the st and ard practice group ( difference of 13 % [ 95 % CI , 3 % to 23 % ] ; P = .011 ) . Fewer RBC transfusions ( week 5 to the end of the treatment period ) occurred in the IV iron group : 9 % versus 20 % in the st and ard practice group ( difference of -11 % [ 95 % CI , -18 % to -3 % ] ; P = .005 ) . Both treatments were well tolerated with no notable differences in adverse events . Serious adverse events related to iron occurred in 3 % of patients in the IV iron group and were mostly gastrointestinal in nature . CONCLUSION Addition of IV iron to darbepoetin alpha Q3W in patients with chemotherapy-induced anemia was well tolerated , result ing in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alpha alone Study Objective A safe alternative to erythropoiesis‐stimulating agents to treat anemia is warranted in patients with cancer and anemia ; thus the objective of this trial was to compare the efficacy and safety of intravenous ( IV ) iron isomaltoside with oral iron in patients with cancer and anemia by testing the noninferiority of IV versus oral iron . Design Phase III , prospect i ve , open‐label , comparative , r and omized , noninferiority , multicenter trial . Setting Forty‐seven hospitals or private cancer clinics in Asia , the United States , and Europe . Patients A total of 350 patients with cancer and anemia . Intervention Patients were r and omized in a 2:1 ratio to either intravenous iron isomaltoside or oral iron sulfate . Patients in the iron isomaltoside group were then r and omized into an infusion subgroup ( single intravenous infusions of a maximum dose of 1000 mg over 15 min ) or a bolus injection subgroup ( bolus injections of 500 mg over 2 min ) . Measurements and Main Results The primary efficacy outcome was change in hemoglobin concentration from baseline to week 4 . Changes in other relevant hematology variables , effect on quality of life , and safety outcomes were also assessed . The primary efficacy outcome was tested for noninferiority , whereas the remaining outcomes were tested for superiority . Iron isomaltoside was noninferior to oral iron in change in hemoglobin concentration from baseline to week 4 ( difference estimate 0.016 , 95 % confidence interval –0.26 to 0.29 , p<0.001 ) . A faster onset of the hemoglobin response was observed with infusion of iron isomaltoside ( superiority test : p=0.03 at week 1 ) , and a sustained effect on hemoglobin level was shown in both the iron isomaltoside and oral iron treatment groups until week 24 . A significant mean decrease in fatigue score was observed from baseline to week 12 in the iron isomaltoside group ( p<0.001 ) but not in the oral iron group ( p=0.057 ) . A higher proportion of patients treated with oral iron  experienced adverse drug reactions ( 18.8 % vs 6.6 % , p<0.001 ) and discontinued the trial due to intolerance ( 8.0 % vs 0.9 % , p=0.001 ) . Transient hypophosphatemia ( phosphate level less than 2 mg/dl ) was reported at similar low frequencies among the groups : 7.1 % in the iron isomaltoside infusion subgroup versus 8.5 % in the iron isomaltoside bolus injection subgroup versus 5.4 % in the oral iron group . Conclusion This trial demonstrated comparable sustained increases in hemoglobin concentration over time with both iron isomaltoside and oral iron . Iron isomaltoside was better tolerated than oral iron , and fatigue was significantly decreased with iron isomaltoside . Low rates of clinical ly insignificant hypophosphatemia were reported in patients receiving both treatments 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 , prospect i ve studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents . Methods We conducted a prospect i ve , double-blind , r and omized 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 out patients . 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 . ( Clinical Trials.gov NCT005936197 January 3 , 2008 ) Background . Iron deficiency anemia ( IDA ) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy . Ferric carboxymaltose ( FCM ) is a stable , nondextran iron formulation administered intravenously in large single doses to treat IDA . Objective . Two open-label , r and omized , placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to st and ard medical care ( SMC ) in IDA patients . Secondary endpoints were improvements in hemoglobin and iron indices . Design and Patients . Adults with hemoglobin ≤12 g/dL , ferritin ≤100 or ≤300 ng/mL with transferrin saturation ≤30 % were r and omized to receive single ( n = 366 ) or weekly ( n = 343 ) FCM or SMC ( n = 360 and n = 366 ) . Results . Significantly greater ( P ≤ 0.001 ) increases in hemoglobin and iron indices occurred in FCM groups versus SMC . In the multidose study , up to two infusions of FCM were needed to reach target iron levels versus 3–5 of intravenous iron comparators . FCM and SMC groups had similar incidences and types of adverse events and serious adverse events . Transient hypophosphatemia not associated with adverse events or clinical sequelae occurred in the FCM groups . Conclusion . Intravenous FCM is safe , well tolerated , and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min . Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations PURPOSE Recombinant human erythropoietin ( rHuEPO ) is the st and ard of care for patients with chemotherapy-related anemia .  Intravenous ( IV ) iron improves hemoglobin ( Hb ) response and decreases dosage requirements in patients with anemia of kidney disease , but its effect has not been studied in r and omized trials in cancer patients . METHODS This prospect i ve , multicenter , open-label , r and omized trial enrolled 157 patients with chemotherapy-related anemia ( Hb < or= 105 g/L , serum ferritin < or= 450 pmol/L or < or= 675 pmol/L with transferrin saturation < or= 19 % ) receiving subcutaneously rHuEPO 40000 U once weekly to : ( 1 ) . no-iron ;  ( 2 )  . oral iron 325 mg twice  daily  ; ( 3 )  iron dextran repeated 100 mg IV bolus ; or ( 4 ) iron dextran total dose infusion ( TDI ) . Hb and quality of life ( QOL ) were measured at baseline and throughout . RESULTS All groups showed Hb ( P < .0001 ) increases from baseline . Mean Hb increases for both IV iron groups were greater ( P < .02 ) than for no-iron and oral iron groups . The percentage of patients with hematopoietic responses was higher ( P < .01 ) in both IV iron groups ( each case 68 % ) compared with no-iron ( 25 % ) and oral iron ( 36 % ) groups . IV iron groups showed increases in energy , activity , and overall QOL from baseline , compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group . CONCLUSION rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia . Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents ( ESA ) , r and omized , controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis ( PD ) patients . In a multicenter trial , patients who had anemia , PD-dependent chronic kidney disease , stable ESA therapy , and a broad range of iron status ( ferritin < or = 500 ng/ml , transferrin saturation < or = 25 % ) were r and omly assigned to receive either 1 g of iron sucrose intravenously in three divided doses ( 300 mg over 1.5 h on days 1 and 15 , 400 mg over 2.5 h on day 29 ) or no supplemental iron . No serious adverse drug events occurred after intravenous iron administration . The primary end point , peak hemoglobin increase , was higher ( 1.3 + /- 1.1 versus 0.7 + /- 1.1 , mean + /- SD ; P = 0.0028 ) , and anemia intervention ( transfusion , increase in ESA dose , or intravenous iron therapy not called for in protocol ) occurred later ( P = 0.0137 ) and less often in intravenous iron-treated patients compared with untreated control subjects ( one of 66 [ 1.3 % ] versus five of 30 [ 16.7 % ] ) . Among patients who did not require intervention , iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects . Baseline iron status did not predict responsiveness to intravenous iron therapy . Intravenous iron sucrose is an effective adjunct to ESA therapy in anemic patients with PD-dependent chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of iron deficiency at baseline is not required to demonstrate intravenous iron efficacy OBJECTIVES The aim of this study was to examine whether intravenous iron III-hydroxide sucrose complex ( IHSC ) used alone was sufficient to provide rapid correction of anemia after cardiac surgery and whether additional stimulation of erythropoiesis is possible by means of a single low dose of recombinant-human erythropoietin ( r-HuEPO ) administration . DESIGN Prospect i ve , r and omized , double-blind study . SETTING The study was conducted in a university hospital . PARTICIPANTS One hundred twenty American Society of Anesthesiologists II or III patients , who underwent elective cardiac surgery using cardiopulmonary bypass and in whom postpump hemoglobin ranged between 7 and 10 g/dL. INTERVENTIONS Patients were divided into 3 groups : group I = control ; group II received postoperative intravenous iron supplementation with an iron III-hydroxide sucrose complex ( IHSC ) ; and group III received IV iron and a single dose of r-HuEPO ( 300 U/kg ) . MEASUREMENTS AND RESULTS No significant difference in transfusion needs was observed among the 3 groups ( 22 % , 25 % , and 17 % of patients transfused in groups I , II , and III , respectively ) . Hemoglobin levels , reticulocyte counts , and serum ferritin levels were evaluated at different time intervals ( until day 30 postoperatively ) . No side effects because of iron administration were noted in the study . Reticulocyte counts increased rapidly at day 5 ( 2.24 % + /- 1.11 % , 1.99 % + /- 1.44 % , and 3.84 % + /- 2.02 % in groups I , II , and III , respectively ) and decreased after day 15 in the 3 groups . Ferritin levels increased significantly at day 5 in the 2 treated groups ( 899.33 + /- 321.55 ng/mL in group II , 845.75 + /- 289.96 ng/mL in group III v 463.15 + /- 227.74 ng/mL in group I ) . In group I , ferritin levels , after a slight elevation on day 5 , decreased at day 15 to lower than baseline levels . No significant difference in hemoglobin increase was noted among the 3 groups . CONCLUSION Postoperative intravenous iron supplementation alone or in combination with a single dose of r-HuEPO ( 300 U/kg ) is not effective in correcting anemia after cardiac surgery Background . Anemia after kidney transplantation has been associated with poor transplant outcomes . We hypothesized that intravenous ( IV ) iron may more rapidly correct anemia than oral ( PO ) iron . Methods . One hundred four kidney transplant recipients were prospect ively  r and omized to IV iron polymaltose ( 500 mg single dose ) or PO ferrous sulfate ( 210 mg elemental iron daily , continuously ) . The primary outcome was time to resolution of anemia , defined as hemoglobin more than or equal to 11 g/dL. Secondary outcomes included infections , blood transfusions , gastrointestinal side-effects , and acute rejection . Results . There was no significant difference in the primary outcome comparing IV with PO iron ( hazards ratio 1.22 ; 95 % confidence interval 0.82–1.83 ; P=0.32 ) . The median time to resolution of anemia was 12 days in the IV group versus 21 days in the PO group . There were no differences in infections ( 20 % vs. 24 % , P=0.62 ) , acute rejection ( 8 % vs. 6 % , P=0.68 ) , blood transfusions ( 10 % vs. 18 % , P=0.24 ) , and severe gastrointestinal side-effects ( 6 % vs. 12 % , P=0.29 ) between the IV iron and the PO iron groups . Conclusions . We conclude that a single dose of IV iron did not result in more rapid resolution of anemia compared with PO iron . Both IV and PO iron are safe and effective in the management of posttransplant anemia Objective : To determine if preoperative intravenous ( IV ) iron improves outcomes in abdominal surgery patients . Summary Background Data : Preoperative iron deficiency anemia ( IDA ) occurs frequently ; however if left untreated , increases the risk of blood transfusion allogeneic blood transfusion ( ABT ) . Limited evidence supports IDA treatment with preoperative IV iron . This r and omized controlled trial aim ed to determine whether perioperative IV iron reduced the need for ABT . Methods : Between August 2011 and November 2014 , 72 patients with IDA were assigned to receive either IV iron or usual care . The primary endpoint was incidence of ABT . Secondary endpoints were various hemoglobin ( Hb ) levels , change in Hb between time points , length of stay , iron status , morbidity , mortality , and quality of life 4 weeks postsurgery . Results : A 60 % reduction in ABT was observed in the IV iron group compared with the usual care group ( 31.25 % vs 12.5 % ) . Hb values , although similar at r and omization , improved by 0.8 g/dL with IV iron compared with 0.1 g/dL with usual care ( P = 0.01 ) by the day of admission . The IV iron group had higher Hb 4 weeks after discharge compared with the usual care group ( 1.9 vs 0.9 g/dL , P = 0.01 ) , and a shorter length of stay ( 7.0 vs 9.7 d , P = 0.026 ) . There was no difference in discharge Hb levels , morbidity , mortality , or quality of life . Conclusions : Administration of perioperative IV iron reduces the need for blood transfusion , and is associated with a shorter hospital stay , enhanced restoration of iron stores , and a higher mean Hb concentration 4 weeks after surgery To compare two modalities of iron supplementation for the preoperative stimulation of erythropoiesis using recombinant human erythropoietin ( rhEPO ) , 12 adults in normal hemoglobin and iron status due for elective surgery were r and omized to rhEPO 200 U/kg body weight subcutaneously twice weekly combined with either iron sucrose 200 mg intravenously twice weekly or iron sulfate 160 mg/day orally , for 3 weeks preoperatively . Efficacy was measured by the increases over baseline in hemoglobin , reticulocyte count , and ferritin determined 3 days before surgery ; preoperative reticulocyte count and ferritin were significantly higher with intravenous iron , whereas the only significant intragroup increases in hemoglobin between time points also occurred in this group . Intravenous iron significantly boosts the hematopoietic response to rhEPO and prevents iatrogenic iron depletion in otherwise healthy c and i date s for elective surgery INTRODUCTION Anemia is the most common finding in chronic kidney disease patients .  Iron supplements are commonly prescribed for these patients with or without erythropoietin therapy by means of oral and intravenous iron . Both oral and intravenous irons have their own advantage and disadvantage , and the efficacy is also different . The objective of the study is to analyze the efficacy of oral and intravenous iron in chronic kidney disease patients on erythropoietin therapy , an erythropoiesis stimulating agents for increment of haemoglobin . METHODS This is a prospect i ve study comparing intravenous iron to oral iron in chronic kidney disease patients who underwent maintenance hemodialysis at different centers and visited Kathm and u Medical College Teaching Hospital from April 2010 to April 2011 . Patients having a haemoglobin level of < 11 g/dl , transferrin saturation ( TSAT ) < 25 % , ferritin < 300ng/ml and who were on erythropoietin therapy were allocated alternately into two groups to receive oral iron ( iron fumarate ) or IV iron ( iv sucrose ) .  Haemoglobin was measured after 30 days of therapy . RESULTS A significant increase in haemoglobin levels was observed in both groups . But the mean haemoglobin increment was more in the IV iron group than in the oral iron group . Sixty percent 60 % of patients in the IV iron group had an increase in the haemoglobin level of more than 1gm/dl while only 20 % of the oral iron group had this increase . CONCLUSIONS Intravenous iron therapy is more effective in raising the hemoglobin level in hemodialysis dependent chronic kidney disease patients BACKGROUND There are concerns about adverse vascular effects of intravenous iron by inducing oxidative stress . We therefore examined the effect of a single high dose of intravenous iron on endothelial function and biochemical markers of iron homeostasis . METHODS In a r and omized , placebo-controlled , double-blind , parallel-group study , forearm blood flow ( FBF ) was assessed by strain-gauge plethysmography in 38 peritoneal dialysis patients before and after a single intravenous infusion of 300 mg iron sucrose . RESULTS Iron infusion increased total ( Delta 601 microg/100 mL , CI 507 , 696 ) and non-transferrin-bound iron ( Delta 237.2 micromol/L , CI 173.6 , 300.8 ) approximately 10-fold , as well as redox-active iron nearly five-fold ( Delta 0.76 micromol/L , CI 0.54 , 0.98 ) . After iron infusion basal FBF was 59 % higher than after placebo . FBF response to acetylcholine before and after iron infusion was 263 + /- 32 % and 310 + /- 33 % , corresponding to 304 + /- 43 % and 373 + /- 29 % in the placebo group , respectively . Before and after iron or placebo infusion , glyceryl-trinitrate increased resting FBF to 232 + /- 22 % and 258 + /- 21 % in the iron group , and to 234 + /- 18 % and 270 + /- 30 % in the placebo group . L-N-monomethyl-arginine decreased FBF to 70 + /- 4 % and 72 + /- 3 % before and after iron , and to 74 + /- 4 % and 73 + /- 4 % before and after placebo infusions , respectively . Despite higher basal FBF after iron infusion , absolute and relative FBF changes in response to vasoactive substances were not significantly different between iron and placebo groups . CONCLUSION Our data suggest that 300 mg intravenous iron sucrose has a vasodilatory effect , but does not impair vascular reactivity in dialysis patients , despite a significant increase in non-transferrin-bound and redox-active iron BACKGROUND Intravenous iron is a recognized therapy of anaemia in chronic haemodialyzed patients , especially in those receiving erythropoietin ( Epo ) , while its role in the anaemia of pre-dialyzed chronic renal failure ( CRF ) patients is much less clear . This study attempted to evaluate the effects of intravenous iron in anaemic pre-dialyzed patients . METHODS Sixty anaemic ( haemoglobin<11 g/dl ) non-diabetic patients with moderate CRF [ 32 males , 28 females ; mean age 52.2+/-12.5 years ; mean glomerular filtration rate 36.2+/-5.2 ml/min ] , without iron deficiency , iron overload or inflammation , without concomitant erythropoietin treatment and without any previous iron therapy were enrolled .  Intravenous iron was administered as iron sucrose , 200 mg elemental iron per month for 12 months , with 1 month pre- study survey and 1 month follow-up after the last iron dose . RESULTS Intravenous iron supplementation was associated with a significant increase in haemoglobin ( from 9.7+/-1.1 at the baseline to 11.3+/-2.5 g/dl after 12 months , a mean increase of 1.6 g/dl ) , a further 36 % of patients reaching the target haemoglobin of 10 g/dl . There was a significant increase in serum iron from 73.9+/-17.2 to 101.8+/-12.2 microg/dl , in serum ferritin from 98.0 ( 24.8 - 139.0 ) to 442.5 ( 86.0 - 496.0 ) microg/l and in transferrin saturation from 21.6+/-2.6 to 33.6+/-3.2 % . No worsening of renal function , no increase in blood pressure and no other side effects were noted . CONCLUSIONS Intravenous iron therapy in pre-dialysis patients with no Epo seems often to ameliorate the anaemia , avoiding the necessity of Epo or blood transfusions in one-third of pre-dialyzed non-diabetic patients . Intravenous iron supplementation appears to be an effective and safe treatment for anaemia in pre-dialysis CRF patients
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
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .