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. Findings: 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. Interpretation: 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. Funding: The Prinses Beatrix Fonds (MAR01-0213) and the Department of Neurology, Academic Medical Center.
|Keywords||Netherlands, United Kingdom, acne vulgaris, adult, aged, alendronic acid, appetite, article, calcium, chronic inflammatory demyelinating polyneuropathy, clinical article, clinical assessment, clinical trial, closed angle glaucoma, confidence interval, controlled clinical trial, controlled study, corticosteroid therapy, dexamethasone, diabetes mellitus, disability, double blind procedure, drug megadose, drug pulse therapy, dyspepsia, female, follow up, glucose intolerance, heartburn, human, hypertension, immunosuppressive treatment, impaired glucose tolerance, infection, insomnia, male, mood change, moon face, multicenter study, multiple cycle treatment, oral antidiabetic agent, osteopenia, osteoporosis, placebo, prednisolone, priority journal, randomized controlled trial, rating scale, remission, side effect, treatment outcome, vitamin D, weight change, wound healing impairment|
|Persistent URL||dx.doi.org/10.1016/S1474-4422(10)70021-1, hdl.handle.net/1765/19463|
|Journal||The Lancet Neurology|
van Schaik, I.N, Eftimov, F, van Doorn, P.A, Brusse, E, van den Berg, L.H, van der Pol, W.L, … Vermeer, M.C. (2010). Pulsed high-dose dexamethasone versus standard prednisolone treatment for chronic inflammatory demyelinating polyradiculoneuropathy (PREDICT study): a double-blind, randomised, controlled trial. The Lancet Neurology, 9(3), 245–253. doi:10.1016/S1474-4422(10)70021-1