High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study.
Therapeutic plasma exchange (PE) is the accepted therapy for thrombotic thrombocytopenic purpura (TTP). Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. Results of present study indicate that the association of PE with high-dose instead of standard-dose steroids reduces the percentage of TTP patients that fail to achieve complete remission.
Balduini
Carlo L
CL
Internal Medicine, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy. c.balduini@smatteo.pv.it
Gugliotta
Luigi
L
Luppi
Mario
M
Laurenti
Luca
L
Klersy
Catherine
C
Pieresca
Carla
C
Quintini
Gerlando
G
Iuliano
Francesco
F
Re
Rossana
R
Spedini
Pierangelo
P
Vianelli
Nicola
N
Zaccaria
Alfonso
A
Pogliani
Enrico Maria
EM
Musso
Roberto
R
Bobbio Pallavicini
Enrico
E
Quarta
Giovanni
G
Galieni
Piero
P
Fragasso
Alberto
A
Casella
Gianluca
G
Noris
Patrizia
P
Ascari
Edoardo
E
D000210:Acute-Phase Reaction / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone