High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial.
This study compared the efficacy and safety of high-dose dexamethasone (HD-DXM) and conventional prednisone (PDN) on the largest cohort to date as first-line strategies for newly diagnosed adult primary immune thrombocytopenia (ITP). Patients enrolled were randomized to receive DXM 40 mg/d for 4 days (n = 95, nonresponders received an additional 4-day course of DXM) or prednisone 1.0 mg/kg daily for 4 weeks and then tapered (n = 97). One or 2 courses of HD-DXM resulted in a higher incidence of overall initial response (82.1% vs 67.4%, P = .044) and complete response (50.5% vs 26.8%, P = .001) compared with prednisone. Time to response was shorter in the HD-DXM arm (P < .001), and a baseline bleeding score ≥8 was associated with a decreased likelihood of initial response. Sustained response was achieved by 40.0% of patients in the HD-DXM arm and 41.2% in the PDN arm (P = .884). Initial complete response was a positive indicator of sustained response, whereas presence of antiplatelet autoantibodies was a negative indicator. HD-DXM was generally tolerated better. We concluded that HD-DXM could be a preferred corticosteroid strategy for first-line management of adult primary ITP. This study is registered at www.clinicaltrials.gov as #NCT01356511.
Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
Yu
Y
Wei
Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
Xue-bin
XB
Ji
Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
Ya-wen
YW
Wang
Department of Hematology, Liaocheng People's Hospital, Liaocheng, China;
Jing-xia
JX
Wang
Department of Hematology, People's Hospital of Rizhao, Rizhao, China;
En-qin
EQ
Yang
Department of Hematology, Central Hospital of Zibo, Zibo, China;
Zheng-cheng
ZC
Wang
Department of Hematology, Heze Municipal Hospital, Heze, China;
Yu-qi
YQ
Sang
Department of Hematology, Zibo First Hospital, Zibo, China;
Zuo-mu
ZM
Bi
Department of Hematology, Weifang People's Hospital, Weifang, China;
Cui-ai
CA
Ren
Department of Hematology, Jinan Military General Hospital, Jinan, China;
Fang
F
Zhou
Department of Hematology, Shengli Oilfield General Hospital, Dongying, China;
Guo-qiang
GQ
Liu
Department of Hematology, Qilu Hospital, Shandong University, Jinan, China; Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education and Chinese Ministry of Health, Qilu Hospital, Shandong University, Jinan, China; and.
Jun
J
Peng
Department of Hematology, Qilu Hospital, Shandong University, Jinan, China; Shandong Provincial Key Laboratory of Immunohematology, Qilu Hospital, Shandong University, Jinan, China.
Ming
M
Hou
D000293:Adolescent; D000328:Adult; D000368:Aged; D001323:Autoantibodies / Q000097:blood / Q000276:immunology; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010976:Platelet Count; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000175:diagnosis / Q000188:drug therapy*; D012074:Remission Induction; D016896:Treatment Outcome; D055815:Young Adult
D001323:Autoantibodies; D007166:Immunosuppressive Agents; D003907:Dexamethasone; D011241:Prednisone