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Erythrocytapheresis versus phlebotomy in the maintenance treatment of HFE hemochromatosis patients: results from a randomized crossover trial
Author(s) -
RomboutSestrienkova Eva,
Winkens Bjorn,
Essers Brigitte A.B.,
Nieman Fred H.M.,
Noord Paulus A.H.,
Janssen Mirian C.H.,
van Deursen Cees Th.B.M.,
Boonen Annelies,
ReuserKaasenbrood Ellen P.J.M.,
Heeremans Judith,
van Kraaij Marian,
Masclee Ad,
Koek Ger H.
Publication year - 2016
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.13328
Subject(s) - phlebotomy , medicine , confidence interval , crossover study , randomized controlled trial , clinical endpoint , surgery , placebo , alternative medicine , pathology
BACKGROUND Phlebotomy is standard maintenance treatment of patients with hereditary hemochromatosis (HH). Erythrocytapheresis, which selectively removes red blood cells, provides a new, potentially more effective treatment option. Our aim was to evaluate the effectiveness of erythrocytapheresis over phlebotomy for maintenance therapy in patients with HH. STUDY DESIGN AND METHODS We conducted a two‐treatment‐arms, randomized, crossover clinical trial, involving 46 patients, treated for 1 year with either erythrocytapheresis or phlebotomy to keep the ferritin level at not more than 50 µg/L. After 1 year, patients were switched to the other treatment modality. Primary endpoint was the number of treatment procedures per treatment year. Secondary endpoints were intertreatment intervals, several aspects of health‐related quality of life, costs, and patient discomfort as well as preference for one of both treatments. RESULTS The mean number of required treatment procedures per treatment year was significantly higher using phlebotomy versus erythrocytapheresis (3.3 vs. 1.9; mean difference, 1.4; 95% confidence interval, 1.1‐1.7). The median intertreatment time was 2.3 times longer for erythrocytapheresis. There was no significant difference in overall health assessed by SF‐36 and EQ‐5D, respectively, between both treatments arms. The number of self‐reported swollen joints was significantly higher during phlebotomy treatment. The mean treatment costs of one treatment year were 235€ for phlebotomy versus 511€ for erythrocytapheresis. Eighty percent of patients preferred erythrocytapheresis as treatment method. CONCLUSION Erythrocytapheresis significantly reduced the number of treatment procedures per treatment year, although the mean treatment costs per year are higher in our health care system. It is the preferred treatment for the majority of patients.