Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone

Isfahan University of Medical Sciences

Status and phase

Completed

Phase 3

Phase 2

Conditions

ITP

Croticosteroid Therapy

Treatments

Drug: High dose Dexamethasone pulses

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT02914054

IUMS (Other Identifier)

Details and patient eligibility

About

In this prospective, randomized, controlled clinical trial investigators' aim was to compare the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional treatment with PDN for untreated adult patients with ITP. In this study standardized criteria and definitions were used according to consensus international working group guideline for ITPto compare clinical outcomes of the two corticosteroid treatment regimens and determine the superior regimen as a first line strategy for new primary ITP in adults

Full description

Therapy of Adults affected by idiopathic thrombocytopenic purpura with 3 cycles pulses of high-dose dexamethasone (HD-DXM): a prospective randomized clinical trial Alireza Sadeghi, Saeid Rezaei Jouzdani, Forough Hosseini

Introduction :

Idiopathic thrombocytopenic purpura(ITP) is an autoimmune disorder characterized by platelet destruction leading to decreased platelet count and an increased risk of bleeding. Mechanisms including autoantibody- mediated platelet destruction, cytotoxic T-lymphocyte platelet lysis, impaired platelet maturation and production has been identified in the pathogenesis of ITP.(1)The first line treatment of ITP is still corticosteroid therapy. Prednisone(PDN) is the standard corticosteroid therapy in ITP practical guideline usually given at 1 mg/kg per day for 4 weeks and then tapered.(2) Recent studies suggested pulsed high-dose dexamethasone given at a dose 40 mg/day to a 4-day course treatment as an alternative corticosteroid instead of prednisone to reduce the duration and the adverse effect of corticosteroid therapy.(3-5) A multicenter randomized clinical trial compared the 2 corticosteroid therapy and suggested that HD-DXM has more effective and better tolerance than PDN.(4) Another multicenter cohort study using repeated courses of HD-DXM (from 6 to 4 cycles, repeated each cycle 28 days to 14 days interval) confirmed the benefit as compared with conventional therapy and proposed as a first-line treatment for patients with ITP. Also there was no difference in overall response rate between the third and the fourth cycles of HD-DXM pulses therapy, using 3 therapy cycles with 14 days interval between each cycle, has been proposed for better safety and efficacy.(5) In this prospective, randomized, controlled clinical trial investigators' aim was to compare the efficacy and the adverse effect of 3 therapy cycles of HD-DXM versus conventional treatment with PDN for untreated adult patients with ITP. In this study standardized criteria and definitions were used according to consensus international working group guideline for ITP(6) to compare clinical outcomes of the two corticosteroid treatment regimens and determine the superior regimen as a first line strategy for new primary ITP in adults.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The eligible patients for this study were aged 18 or older of both genders with newly diagnosed primary ITP according to the international working group (IWG) guideline(6). All patients included in the study were treatment naïve ITP within 3 months from diagnosis and a platelet count of no more the 30×10^9/L, or more than 30×10^9/L with presence of bleeding symptoms according to the grading score of bleeding

Exclusion criteria

malignancy, pregnancy or lactation, liver and kidney failure, connective tissue disorders, seropositive detection of HIV, hepatitis B virus or hepatitis C virus or any recent viral infection, active infection, diabetes, hypertension, cardiovascular disorders, autoimmune hemolytic anemia, psychosis, osteoporosis, any corticosteroid or immunosuppressive therapy in 3 months before diagnosis and any previous ITP-specific therapy.