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Initial management of immune thrombocytopenic purpura in adults: A randomized controlled trial comparing intermittent anti‐D with routine care
Author(s) -
George James N.,
Raskob Gary E.,
Vesely Sara K.,
Moore Dennis,
Lyons Roger M.,
Cobos Everardo,
Towell Brenda L.,
Klug Panpit,
Guthrie Troy H.
Publication year - 2003
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.10424
Subject(s) - splenectomy , medicine , randomization , randomized controlled trial , regimen , prednisone , thrombocytopenic purpura , interquartile range , surgery , group b , platelet , spleen
Abstract We conducted a randomized clinical trial in adults with a new diagnosis of ITP and a platelet count <30,000/μL to test the hypothesis that initial intermittent treatment with anti‐D may avoid or defer the need for splenectomy when compared to current routine care (glucocorticoid treatment, followed by splenectomy). Splenectomy was to be performed in the anti‐D group if patients failed to respond to three consecutive anti‐D treatments given within 10 days. The incidences of splenectomy were 14 of 37 (38%) in the routine care group and 14 of 33 (42%) in the anti‐D group (absolute risk reduction = 4.6% in favor of the routine care group, 95% CI, −18.4 to 27.6%). However, splenectomy was performed prematurely, not according to the protocol, in 11 of 14 patients in the anti‐D group. The median time to splenectomy was 36 days (range, 9–78) in the routine care group and 112 days (range, 19–558) in the anti‐D group ( P = 0.045 at 100 days after randomization, P = 0.840 at 1 year after randomization, using log‐rank analysis). Patients in the anti‐D group were treated with prednisone for fewer days (70 days) compared to the routine care group (112 days, P = 0.01). No major bleeding events occurred. In this study, initial treatment of patients with intermittent anti‐D initially deferred splenectomy. Whether our aggressive regimen of anti‐D could have prevented splenectomy if it had been adhered to in all patients remains uncertain. However, compliance with this anti‐D regimen was not feasible for many patients and/or their physicians. Am. J. Hematol. 74:161–169, 2003. © 2003 Wiley‐Liss, Inc.