Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial

E. Rombout-Sestrienkova, F.H.M. Nieman, B.A.B. Essers, P.A.H. van Noord, M.C.H. Janssen, C.Th.B.M. van Deursen, L.P. Bos, F. Rombout, R. van den Braak, P.W. de Leeuw, G.H. Koek

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Abstract

BACKGROUND: Standard treatment of newly diagnosed HFE hemochromatosis patients is phlebotomy. Erythrocytapheresis provides a new therapeutic modality that can remove up to three times more red blood cells per single procedure and could thus have a clinical and economic benefit. STUDY DESIGN AND METHODS: To compare the number of treatment procedures between erythrocytapheresis and phlebotomy needed to reach the serum ferritin (SF) target level of 50 microg/L, a two-treatment-arms, randomized trial was conducted in which 38 newly diagnosed patients homozygous for C282Y were randomly assigned in a 1:1 ratio to undergo either erythrocytapheresis or phlebotomy. A 50% decrease in the number of treatment procedures for erythrocytapheresis compared to phlebotomy was chosen as the relevant difference to detect. RESULTS: Univariate analysis showed a significantly lower mean number of treatment procedures in the erythrocytapheresis group (9 vs. 27; ratio, 0.33; 95% confidence interval [CI], 0.25-0.45; Mann-Whitney p < 0.001). After adjustments for the two important influential factors initial SF level and body weight, the reduction ratio was still significant (0.43; 95% CI, 0.35-0.52; p < 0.001). Cost analysis showed no significant difference in treatment costs between both procedures. The costs resulting from productivity loss were significantly lower for the erythrocytapheresis group. CONCLUSION: Erythrocytapheresis is highly effective treatment to reduce iron overload and from a societal perspective might potentially also be a cost-saving therapy.
Original languageEnglish
Pages (from-to)470-477
JournalTransfusion
Volume52
Issue number3
DOIs
Publication statusPublished - 1 Jan 2012

Cite this

Rombout-Sestrienkova, E. ; Nieman, F.H.M. ; Essers, B.A.B. ; van Noord, P.A.H. ; Janssen, M.C.H. ; van Deursen, C.Th.B.M. ; Bos, L.P. ; Rombout, F. ; van den Braak, R. ; de Leeuw, P.W. ; Koek, G.H. / Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. In: Transfusion. 2012 ; Vol. 52, No. 3. pp. 470-477.
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abstract = "BACKGROUND: Standard treatment of newly diagnosed HFE hemochromatosis patients is phlebotomy. Erythrocytapheresis provides a new therapeutic modality that can remove up to three times more red blood cells per single procedure and could thus have a clinical and economic benefit. STUDY DESIGN AND METHODS: To compare the number of treatment procedures between erythrocytapheresis and phlebotomy needed to reach the serum ferritin (SF) target level of 50 microg/L, a two-treatment-arms, randomized trial was conducted in which 38 newly diagnosed patients homozygous for C282Y were randomly assigned in a 1:1 ratio to undergo either erythrocytapheresis or phlebotomy. A 50{\%} decrease in the number of treatment procedures for erythrocytapheresis compared to phlebotomy was chosen as the relevant difference to detect. RESULTS: Univariate analysis showed a significantly lower mean number of treatment procedures in the erythrocytapheresis group (9 vs. 27; ratio, 0.33; 95{\%} confidence interval [CI], 0.25-0.45; Mann-Whitney p < 0.001). After adjustments for the two important influential factors initial SF level and body weight, the reduction ratio was still significant (0.43; 95{\%} CI, 0.35-0.52; p < 0.001). Cost analysis showed no significant difference in treatment costs between both procedures. The costs resulting from productivity loss were significantly lower for the erythrocytapheresis group. CONCLUSION: Erythrocytapheresis is highly effective treatment to reduce iron overload and from a societal perspective might potentially also be a cost-saving therapy.",
author = "E. Rombout-Sestrienkova and F.H.M. Nieman and B.A.B. Essers and {van Noord}, P.A.H. and M.C.H. Janssen and {van Deursen}, C.Th.B.M. and L.P. Bos and F. Rombout and {van den Braak}, R. and {de Leeuw}, P.W. and G.H. Koek",
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Rombout-Sestrienkova, E, Nieman, FHM, Essers, BAB, van Noord, PAH, Janssen, MCH, van Deursen, CTBM, Bos, LP, Rombout, F, van den Braak, R, de Leeuw, PW & Koek, GH 2012, 'Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial', Transfusion, vol. 52, no. 3, pp. 470-477. https://doi.org/10.1111/j.1537-2995.2011.03292.x

Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. / Rombout-Sestrienkova, E.; Nieman, F.H.M.; Essers, B.A.B.; van Noord, P.A.H.; Janssen, M.C.H.; van Deursen, C.Th.B.M.; Bos, L.P.; Rombout, F.; van den Braak, R.; de Leeuw, P.W.; Koek, G.H.

In: Transfusion, Vol. 52, No. 3, 01.01.2012, p. 470-477.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial

AU - Rombout-Sestrienkova, E.

AU - Nieman, F.H.M.

AU - Essers, B.A.B.

AU - van Noord, P.A.H.

AU - Janssen, M.C.H.

AU - van Deursen, C.Th.B.M.

AU - Bos, L.P.

AU - Rombout, F.

AU - van den Braak, R.

AU - de Leeuw, P.W.

AU - Koek, G.H.

PY - 2012/1/1

Y1 - 2012/1/1

N2 - BACKGROUND: Standard treatment of newly diagnosed HFE hemochromatosis patients is phlebotomy. Erythrocytapheresis provides a new therapeutic modality that can remove up to three times more red blood cells per single procedure and could thus have a clinical and economic benefit. STUDY DESIGN AND METHODS: To compare the number of treatment procedures between erythrocytapheresis and phlebotomy needed to reach the serum ferritin (SF) target level of 50 microg/L, a two-treatment-arms, randomized trial was conducted in which 38 newly diagnosed patients homozygous for C282Y were randomly assigned in a 1:1 ratio to undergo either erythrocytapheresis or phlebotomy. A 50% decrease in the number of treatment procedures for erythrocytapheresis compared to phlebotomy was chosen as the relevant difference to detect. RESULTS: Univariate analysis showed a significantly lower mean number of treatment procedures in the erythrocytapheresis group (9 vs. 27; ratio, 0.33; 95% confidence interval [CI], 0.25-0.45; Mann-Whitney p < 0.001). After adjustments for the two important influential factors initial SF level and body weight, the reduction ratio was still significant (0.43; 95% CI, 0.35-0.52; p < 0.001). Cost analysis showed no significant difference in treatment costs between both procedures. The costs resulting from productivity loss were significantly lower for the erythrocytapheresis group. CONCLUSION: Erythrocytapheresis is highly effective treatment to reduce iron overload and from a societal perspective might potentially also be a cost-saving therapy.

AB - BACKGROUND: Standard treatment of newly diagnosed HFE hemochromatosis patients is phlebotomy. Erythrocytapheresis provides a new therapeutic modality that can remove up to three times more red blood cells per single procedure and could thus have a clinical and economic benefit. STUDY DESIGN AND METHODS: To compare the number of treatment procedures between erythrocytapheresis and phlebotomy needed to reach the serum ferritin (SF) target level of 50 microg/L, a two-treatment-arms, randomized trial was conducted in which 38 newly diagnosed patients homozygous for C282Y were randomly assigned in a 1:1 ratio to undergo either erythrocytapheresis or phlebotomy. A 50% decrease in the number of treatment procedures for erythrocytapheresis compared to phlebotomy was chosen as the relevant difference to detect. RESULTS: Univariate analysis showed a significantly lower mean number of treatment procedures in the erythrocytapheresis group (9 vs. 27; ratio, 0.33; 95% confidence interval [CI], 0.25-0.45; Mann-Whitney p < 0.001). After adjustments for the two important influential factors initial SF level and body weight, the reduction ratio was still significant (0.43; 95% CI, 0.35-0.52; p < 0.001). Cost analysis showed no significant difference in treatment costs between both procedures. The costs resulting from productivity loss were significantly lower for the erythrocytapheresis group. CONCLUSION: Erythrocytapheresis is highly effective treatment to reduce iron overload and from a societal perspective might potentially also be a cost-saving therapy.

U2 - 10.1111/j.1537-2995.2011.03292.x

DO - 10.1111/j.1537-2995.2011.03292.x

M3 - Article

VL - 52

SP - 470

EP - 477

JO - Transfusion

JF - Transfusion

SN - 0041-1132

IS - 3

ER -