ORAL HIGH DOSE LIPOSOMIAL IRON VS INTRAVENOUS IRON IN SIDEROPENIC ANEMIA PATIENTS INTOLERANT/REFRACTORY TO IRON SULPHATE. MULTICENTRIC RANDOMIZED STUDY.
(Abstract release date: 05/19/16)
EHA Library. GIORDANO G. 06/09/16; 133033; E1484
Dr. GIULIO GIORDANO
Contributions
Contributions
Abstract
Abstract: E1484
Type: Eposter Presentation
Background
In iron deficiency anemia support with intravenous iron allows a faster anaemia correction and a faster ferritin increase than iron sulfate. Frequently iron sulfate and intravenous iron generate adverse events as hypotension, urticarioyd reactions, shock, epygastralgia, constipation or diarrhea. High doses of oral iron frequently are poorly tolerated because of adverse events.
Aims
Aim of this study is to verify if high doses of oral liposomial iron are safe, cost-effective and well tolerated as standard doses of intravenous ferrigluconate in patients with iron deficiency anemia intolerant/refractory to iron sulphate.
Methods
We considered two group of patients(RANDOMIZED 1:1) with iron deficiency anemia without other relevant comorbidities. In group A M/F was 2/3, 15 patients had haemorragic gastritis, 8 hemorragic enteric bleeding angiodysplasia, 22 hypermenorrhaea, median level of hemoglobin (Hb) was 8.5 g/dl(R 6.5-10), median ferritin level was 5 ng/ml (R 3-21), with a normal level of CRP or ESR, and received liposomial iron 30 mg 4 tablet/day. In group B M/F was 2/3, 18 patients had haemorragic gastritis, 6 hemorragic enteric bleeding angiodysplasia, 21 hypermenorrhaea, median level of Hb was 8.2 g/dl(R 7.5-9.5), median ferritin level was 7 ng/ml (R 2-19), with a normal level of CRP or ESR, and received iv sodium ferrigluconate 62.5 mg iv in NS 100 ml in 3 h/day. The median treatment costs in each group were calculated considering the monthly global treatment cost for each patients in the treatment period. This provided an estimate of the costs, independent of the precise cost of the drug, but tied to the final outcome (efficacy) of the therapeutic strategy used during the observation period.
Results
In group A,1g Hb increase was observed after a median of 9 days(R 7-15), a target Hb level of 12 g/dl was achieved in a median time of 4 weeks(R 2-5) with a median cost of € 120/months (R 95-180), 12 (26%) patients showed adverse events(7 epigastralgia, 5 diarrhoea). In group B,1 g Hb increase was observed after a median of 7 days(R 6-11), a target Hb level of12 g/dl was achieved in a median time of 3 weeks(R 1.5-4)with a median cost of €300/months(R 250-380), 10(22%) patients showed adverse events(2 hypotension, 2urticaria and headhace).
Conclusion
Oral high dose liposomial iron support is safe, fast, well tolerated and cost-effective as intravenous iron in sideropenic anemia. This study needs confirmation on a larger cohort of patients.
Session topic: E-poster
Type: Eposter Presentation
Background
In iron deficiency anemia support with intravenous iron allows a faster anaemia correction and a faster ferritin increase than iron sulfate. Frequently iron sulfate and intravenous iron generate adverse events as hypotension, urticarioyd reactions, shock, epygastralgia, constipation or diarrhea. High doses of oral iron frequently are poorly tolerated because of adverse events.
Aims
Aim of this study is to verify if high doses of oral liposomial iron are safe, cost-effective and well tolerated as standard doses of intravenous ferrigluconate in patients with iron deficiency anemia intolerant/refractory to iron sulphate.
Methods
We considered two group of patients(RANDOMIZED 1:1) with iron deficiency anemia without other relevant comorbidities. In group A M/F was 2/3, 15 patients had haemorragic gastritis, 8 hemorragic enteric bleeding angiodysplasia, 22 hypermenorrhaea, median level of hemoglobin (Hb) was 8.5 g/dl(R 6.5-10), median ferritin level was 5 ng/ml (R 3-21), with a normal level of CRP or ESR, and received liposomial iron 30 mg 4 tablet/day. In group B M/F was 2/3, 18 patients had haemorragic gastritis, 6 hemorragic enteric bleeding angiodysplasia, 21 hypermenorrhaea, median level of Hb was 8.2 g/dl(R 7.5-9.5), median ferritin level was 7 ng/ml (R 2-19), with a normal level of CRP or ESR, and received iv sodium ferrigluconate 62.5 mg iv in NS 100 ml in 3 h/day. The median treatment costs in each group were calculated considering the monthly global treatment cost for each patients in the treatment period. This provided an estimate of the costs, independent of the precise cost of the drug, but tied to the final outcome (efficacy) of the therapeutic strategy used during the observation period.
Results
In group A,1g Hb increase was observed after a median of 9 days(R 7-15), a target Hb level of 12 g/dl was achieved in a median time of 4 weeks(R 2-5) with a median cost of € 120/months (R 95-180), 12 (26%) patients showed adverse events(7 epigastralgia, 5 diarrhoea). In group B,1 g Hb increase was observed after a median of 7 days(R 6-11), a target Hb level of12 g/dl was achieved in a median time of 3 weeks(R 1.5-4)with a median cost of €300/months(R 250-380), 10(22%) patients showed adverse events(2 hypotension, 2urticaria and headhace).
Conclusion
Oral high dose liposomial iron support is safe, fast, well tolerated and cost-effective as intravenous iron in sideropenic anemia. This study needs confirmation on a larger cohort of patients.
Session topic: E-poster
Abstract: E1484
Type: Eposter Presentation
Background
In iron deficiency anemia support with intravenous iron allows a faster anaemia correction and a faster ferritin increase than iron sulfate. Frequently iron sulfate and intravenous iron generate adverse events as hypotension, urticarioyd reactions, shock, epygastralgia, constipation or diarrhea. High doses of oral iron frequently are poorly tolerated because of adverse events.
Aims
Aim of this study is to verify if high doses of oral liposomial iron are safe, cost-effective and well tolerated as standard doses of intravenous ferrigluconate in patients with iron deficiency anemia intolerant/refractory to iron sulphate.
Methods
We considered two group of patients(RANDOMIZED 1:1) with iron deficiency anemia without other relevant comorbidities. In group A M/F was 2/3, 15 patients had haemorragic gastritis, 8 hemorragic enteric bleeding angiodysplasia, 22 hypermenorrhaea, median level of hemoglobin (Hb) was 8.5 g/dl(R 6.5-10), median ferritin level was 5 ng/ml (R 3-21), with a normal level of CRP or ESR, and received liposomial iron 30 mg 4 tablet/day. In group B M/F was 2/3, 18 patients had haemorragic gastritis, 6 hemorragic enteric bleeding angiodysplasia, 21 hypermenorrhaea, median level of Hb was 8.2 g/dl(R 7.5-9.5), median ferritin level was 7 ng/ml (R 2-19), with a normal level of CRP or ESR, and received iv sodium ferrigluconate 62.5 mg iv in NS 100 ml in 3 h/day. The median treatment costs in each group were calculated considering the monthly global treatment cost for each patients in the treatment period. This provided an estimate of the costs, independent of the precise cost of the drug, but tied to the final outcome (efficacy) of the therapeutic strategy used during the observation period.
Results
In group A,1g Hb increase was observed after a median of 9 days(R 7-15), a target Hb level of 12 g/dl was achieved in a median time of 4 weeks(R 2-5) with a median cost of € 120/months (R 95-180), 12 (26%) patients showed adverse events(7 epigastralgia, 5 diarrhoea). In group B,1 g Hb increase was observed after a median of 7 days(R 6-11), a target Hb level of12 g/dl was achieved in a median time of 3 weeks(R 1.5-4)with a median cost of €300/months(R 250-380), 10(22%) patients showed adverse events(2 hypotension, 2urticaria and headhace).
Conclusion
Oral high dose liposomial iron support is safe, fast, well tolerated and cost-effective as intravenous iron in sideropenic anemia. This study needs confirmation on a larger cohort of patients.
Session topic: E-poster
Type: Eposter Presentation
Background
In iron deficiency anemia support with intravenous iron allows a faster anaemia correction and a faster ferritin increase than iron sulfate. Frequently iron sulfate and intravenous iron generate adverse events as hypotension, urticarioyd reactions, shock, epygastralgia, constipation or diarrhea. High doses of oral iron frequently are poorly tolerated because of adverse events.
Aims
Aim of this study is to verify if high doses of oral liposomial iron are safe, cost-effective and well tolerated as standard doses of intravenous ferrigluconate in patients with iron deficiency anemia intolerant/refractory to iron sulphate.
Methods
We considered two group of patients(RANDOMIZED 1:1) with iron deficiency anemia without other relevant comorbidities. In group A M/F was 2/3, 15 patients had haemorragic gastritis, 8 hemorragic enteric bleeding angiodysplasia, 22 hypermenorrhaea, median level of hemoglobin (Hb) was 8.5 g/dl(R 6.5-10), median ferritin level was 5 ng/ml (R 3-21), with a normal level of CRP or ESR, and received liposomial iron 30 mg 4 tablet/day. In group B M/F was 2/3, 18 patients had haemorragic gastritis, 6 hemorragic enteric bleeding angiodysplasia, 21 hypermenorrhaea, median level of Hb was 8.2 g/dl(R 7.5-9.5), median ferritin level was 7 ng/ml (R 2-19), with a normal level of CRP or ESR, and received iv sodium ferrigluconate 62.5 mg iv in NS 100 ml in 3 h/day. The median treatment costs in each group were calculated considering the monthly global treatment cost for each patients in the treatment period. This provided an estimate of the costs, independent of the precise cost of the drug, but tied to the final outcome (efficacy) of the therapeutic strategy used during the observation period.
Results
In group A,1g Hb increase was observed after a median of 9 days(R 7-15), a target Hb level of 12 g/dl was achieved in a median time of 4 weeks(R 2-5) with a median cost of € 120/months (R 95-180), 12 (26%) patients showed adverse events(7 epigastralgia, 5 diarrhoea). In group B,1 g Hb increase was observed after a median of 7 days(R 6-11), a target Hb level of12 g/dl was achieved in a median time of 3 weeks(R 1.5-4)with a median cost of €300/months(R 250-380), 10(22%) patients showed adverse events(2 hypotension, 2urticaria and headhace).
Conclusion
Oral high dose liposomial iron support is safe, fast, well tolerated and cost-effective as intravenous iron in sideropenic anemia. This study needs confirmation on a larger cohort of patients.
Session topic: E-poster
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