PMID- 29190579
OWN - NLM
STAT- MEDLINE
DCOM- 20181213
LR  - 20181213
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 78
DP  - 2018 Jan
TI  - Efficacy and safety of vigabatrin in Japanese patients with infantile spasms: 
      Primary short-term study and extension study.
PG  - 134-141
LID - S1525-5050(17)30472-9 [pii]
LID - 10.1016/j.yebeh.2017.09.010 [doi]
AB  - Vigabatrin was approved for the treatment of infantile spasms by the US Food and 
      Drug Administration, but not in Japan at the time of initiating this clinical 
      study because of concerns about irreversible peripheral visual field defects 
      (VFDs). This study evaluated the efficacy and safety of vigabatrin for Japanese 
      patients with infantile spasms. Of 15 patients (aged >/=4weeks and <2years) 
      enrolled, with the exception of two patients who did not receive vigabatrin, 13 
      were treated with a titrated dosage of vigabatrin (50-150mg/kg/day; limited to 
      3000mg/day). Twelve out of 13 patients receiving vigabatrin had spasms that were 
      treatment refractory; these patients were concurrently treated with at least one 
      other antiepileptic drug. One patient received vigabatrin monotherapy. Eight of 
      the 13 patients (61.5% [95% CI: 31.6-86.1%]) had a >/=50% reduction during the 
      dose-adjustment phase compared with baseline in the frequency of spasms, with 
      efficacy maintained through a 2-week maintenance phase. Spasms disappeared in six 
      out of nine patients (66.7% [95% CI: 29.9-92.5%]) who transitioned to the 
      maintenance phase and hypsarrhythmia on electroencephalography also resolved in 
      four patients. Hypsarrhythmia was improved in another two patients. Six out of 
      seven patients who continued treatment through Week 32 of an extension study 
      reported ongoing efficacy for vigabatrin. The most common adverse events (AEs) 
      were psychiatric disorders and nervous system disorders (n=8; 61.5%) that were 
      generally mild in severity. No treatment-related peripheral VFDs were observed. 
      No severe AEs or AEs resulting in discontinuation of vigabatrin therapy were 
      reported. An abnormality in magnetic resonance images was observed in one patient 
      during the extension period. Vigabatrin was deemed to be clinically effective and 
      well tolerated in Japanese patients with infantile spasms.
CI  - Copyright (c) 2017 The Author. Published by Elsevier Inc. All rights reserved.
FAU - Ohtsuka, Yoko
AU  - Ohtsuka Y
AD  - Department of Child Neurology, Asahigawaso Rehabilitation and Medical Center, 866 
      Gion, Kita-ku, Okayama, Japan. Electronic address: ohtsuka@okayama-u.ac.jp.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20171222
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
RN  - 9002-60-2 (Adrenocorticotropic Hormone)
RN  - GR120KRT6K (Vigabatrin)
SB  - IM
MH  - Adrenocorticotropic Hormone/therapeutic use
MH  - Anticonvulsants/adverse effects/*therapeutic use
MH  - Child, Preschool
MH  - Electroencephalography
MH  - Female
MH  - Humans
MH  - Infant
MH  - Japan
MH  - Male
MH  - Spasms, Infantile/*drug therapy/ethnology
MH  - Treatment Outcome
MH  - Vigabatrin/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Efficacy
OT  - Hypsarrhythmia
OT  - Infantile spasms
OT  - Safety
OT  - Vigabatrin
OT  - West syndrome
EDAT- 2017/12/01 06:00
MHDA- 2018/12/14 06:00
CRDT- 2017/12/01 06:00
PHST- 2017/06/07 00:00 [received]
PHST- 2017/09/15 00:00 [revised]
PHST- 2017/09/15 00:00 [accepted]
PHST- 2017/12/01 06:00 [pubmed]
PHST- 2018/12/14 06:00 [medline]
PHST- 2017/12/01 06:00 [entrez]
AID - S1525-5050(17)30472-9 [pii]
AID - 10.1016/j.yebeh.2017.09.010 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2018 Jan;78:134-141. doi: 10.1016/j.yebeh.2017.09.010. Epub 2017 
      Dec 22.