Pulsed high-dose dexamethasone versus standard prednisolone treatment for chronic inflammatory demyelinating polyradiculoneuropathy (PREDICT study): a double-blind, randomised, controlled trial.
BACKGROUND
Pulsed high-dose dexamethasone induced long-lasting remission in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in a pilot study. The PREDICT study aimed to compare remission rates in patients with CIDP treated with high-dose dexamethasone with rates in patients treated with standard oral prednisolone.


METHODS
In eight neuromuscular centres in the Netherlands and one in the UK, patients aged 18 years or older who had newly diagnosed definite or probable CIDP were randomly assigned to a treatment regimen of either pulsed high-dose dexamethasone or standard oral prednisolone. Randomisation was done with a random number generator. The primary outcome measure was remission at 12 months, defined as improvement of at least three points on the Rivermead mobility index and improvement of at least one point on the inflammatory neuropathy cause and treatment disability scale. Analysis was by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN07779236.


RESULTS
Between December, 2003, and December, 2008, 40 patients were treated: 24 received dexamethasone and 16 received prednisolone. At 12 months, 16 patients were in remission: ten in the dexamethasone group and six in the prednisolone group (odds ratio [OR] 1.2, 95% CI 0.3-4.4). Most adverse events were minor and did not differ substantially between treatment groups; however, sleeplessness and Cushing's face occurred more often in the prednisolone group.


CONCLUSIONS
Pulsed high-dose dexamethasone treatment did not induce remission more often than prednisolone treatment. A substantial proportion of patients were in remission at 12 months in both treatment groups. High-dose dexamethasone could be considered as induction therapy in CIDP, but comparison with intravenous immunoglobulin treatment is needed.


BACKGROUND
The Prinses Beatrix Fonds (MAR01-0213) and the Department of Neurology, Academic Medical Center.
Department of Neurology, Academic Medical Center, University of Amsterdam, Netherlands. i.n.vanschaik@amc.uva.nl
Ivo N
IN
van Schaik
Filip
F
Eftimov
Pieter A
PA
van Doorn
Esther
E
Brusse
Leonard H
LH
van den Berg
W Ludo
WL
van der Pol
Catharina G
CG
Faber
Joost C H
JC
van Oostrom
Oscar J M
OJ
Vogels
Rob D M
RD
Hadden
Bert U
BU
Kleine
Anouk G W
AG
van Norden
Jan J G M
JJ
Verschuuren
Marcel G W
MG
Dijkgraaf
Marinus
M
Vermeulen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D020277:Polyradiculoneuropathy, Chronic Inflammatory Demyelinating / Q000188:drug therapy* / Q000503:physiopathology; D011239:Prednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D012074:Remission Induction; D016896:Treatment Outcome
D003907:Dexamethasone; D011239:Prednisolone