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 .
Intravenous Iron Sucrose in Chinese Hemodialysis Patients with Renal Anemia
Background / Aims : Renal anemia is one of the commonest complications of chronic renal failure . Iron deficiency is the most common factor which affects the efficacy of recombinant human erythropoietin ( EPO ) therapy . Intravenous ( i.v . ) iron preparations are commonly used in Western countries , but iron sucrose is seldom used in Chinese patients on maintenance hemodialysis . The aim of the present study was to explore the safety and efficacy of i.v . iron sucrose in Chinese patients on maintenance hemodialysis and to explore the optimal administration frequency . Methods : One hundred and thirty-six patients on maintenance hemodialysis were involved in this r and omized , controlled , parallel-group , single-center trial . Seventy patients received i.v . iron sucrose ( Venofer ® , delivering 100 mg iron ) twice a week for 8 weeks , then once a week for another 4 weeks . The other 66 patients received oral ( p.o . ) ferrous succinate 200 mg t.i.d . for 12 weeks . Levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , hemoglobin ( Hb ) and hematocrit ( Hct ) were assessed at baseline and then again after 4 , 8 and 12 weeks of treatment . Results : There were no differences between i.v . and p.o . groups in terms of sex , age , duration of hemodialysis , dialysis frequency per week , EPO dosage per week , the level of intact parathyroid hormone , serum creatinine , blood urea nitrogen , or hematological parameters at baseline . After 8 and 12 weeks of treatment , mean Hb concentration and Hct were significantly increased in the i.v . group , and were also significantly higher than those in the p.o . group . Levels of SF and TSAT were also significantly increased in the i.v . group , and significantly higher than in the p.o . group . After 8 weeks , the response rate in the i.v . group was 88.6 % , which was significantly higher than that in the p.o . group . The mean EPO dose was significantly lower in the i.v . group than the p.o . group . Hb , Hct , SF and TSAT levels were maintained between 8 and 12 weeks in the i.v . group despite the decrease in dose frequency . There were no adverse events related to i.v . iron administration . Twenty-two patients in the p.o . group had adverse gastrointestinal effects . After 12 weeks , the cost of EPO + i.v . iron was significantly higher than the cost of EPO + p.o . iron . Conclusion : Intravenous iron sucrose can effectively increase serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and is well tolerated . Infusion of i.v . iron sucrose 100 mg per week can maintain serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and can permit reductions in the required dose of EPO . However , the total cost of i.v . iron is relatively high
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 .