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Comparison of two high doses of oral methylprednisolone for multiple sclerosis relapses: a pilot, multicentre, randomized, double‐blind, non‐inferiority trial
Author(s) -
HervásGarcía J. V.,
RamióTorrentà L.,
BrievaRuiz L.,
BatlléNadal J.,
Moral E.,
Blanco Y.,
CanoOrgaz A.,
PresasRodríguez S.,
Torres F.,
Capellades J.,
RamoTello C.
Publication year - 2019
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.13851
Subject(s) - medicine , double blind , multiple sclerosis , pilot trial , methylprednisolone , randomized controlled trial , physical therapy , placebo , alternative medicine , psychiatry , pathology
Background and purpose Oral or intravenous methylprednisolone (≥500 mg/day for 5 days) is recommended for multiple sclerosis (MS) relapses. Nonetheless, the optimal dose remains uncertain. We compared clinical and radiological effectiveness, safety and quality of life (QoL) of oral methylprednisolone [1250 mg/day (standard high dose)] versus 625 mg/day (lesser high dose), both for 3 days] in MS relapses. Methods A total of 49 patients with moderate to severe MS relapse within the previous 15 days were randomized in a pilot, double‐blind, multicentre, non‐inferiority trial (ClinicalTrial.gov, NCT01986998). The primary endpoint was non‐inferiority of the lesser high dose by Expanded Disability Status Scale (EDSS) score improvement on day 30 (non‐inferiority margin, 1 point). The secondary endpoints were EDSS score change on days 7 and 90, changes in T1 gadolinium‐enhanced and new/enlarged T2 lesions on days 7 and 30, and safety and QoL results. Results The primary outcome was achieved [mean (95% confidence interval) EDSS score difference, −0.26 (−0.7 to 0.18) at 30 days ( P = 0.246)]. The standard high dose yielded a superior EDSS score improvement on day 7 ( P = 0.028). No differences were observed in EDSS score on day 90 ( P = 0.352) or in the number of T1 gadolinium‐enhanced or new/enlarged T2 lesions on day 7 ( P = 0.401, 0.347) or day 30 ( P = 0.349, 0.529). Safety and QoL were good at both doses. Conclusions A lesser high‐dose oral methylprednisolone regimen may not be inferior to the standard high dose in terms of clinical and radiological response.