PMID- 22036917
OWN - NLM
STAT- MEDLINE
DCOM- 20120508
LR  - 20221207
IS  - 1878-4216 (Electronic)
IS  - 0278-5846 (Linking)
VI  - 36
IP  - 2
DP  - 2012 Mar 30
TI  - Long-term efficacy and safety of gabapentin enacarbil in Japanese restless legs 
      syndrome patients.
PG  - 251-7
LID - 10.1016/j.pnpbp.2011.10.009 [doi]
AB  - Several short- and long-term studies conducted in Europe/North America have 
      demonstrated good efficacy and tolerability of 600-1800 mg gabapentin enacarbil 
      (GEn). However, no studies have evaluated the efficacy of long-term treatment 
      with GEn in Asian patients. Therefore, the objective of this study was to 
      evaluate the efficacy and safety of long-term treatment with GEn in Japanese 
      patients with restless legs syndrome (RLS) in a multicenter open-label study. RLS 
      patients aged 20-80 years were allocated to receive oral GEn 1200 mg/day for a 
      treatment period of 52 weeks. International Restless Legs Syndrome Scale (IRLS) 
      score, investigator- and patient-rated Clinical Global Impression (CGI) scores, 
      Pittsburgh Sleep Quality Index (PSQI) total scores and subscores, and short form 
      (SF)-36 subscores were assessed, and adverse events (AEs) were monitored. In 181 
      patients (mean age, 54.9+/-12.2 years; BMI, 23.0+/-2.6 kg/m(2)) IRLS score decreased 
      from 24.4+/-0.4 at baseline to 6.3+/-0.6 at week 52, with a reduction of -18.0+/-0.6. 
      The IRLS responder rate was 80.3% at week 52. ICGI and PCGI responder rates were 
      87.1% and 87.1%, respectively. PSQI and SF-36 also showed significant 
      improvements. AEs were reported in 96.2% of patients but remained 
      mild-to-moderate in nearly all the cases. Serious AEs occurred in 1.6%. Dizziness 
      and somnolence were noted in 46.2% and 41.2% of patients, respectively, and 
      mostly occurred during the first 4 weeks. No episodes of augmentation were 
      reported. In conclusion, long-term treatment with GEn improved RLS symptoms as 
      well as investigator- and patient-reported outcomes in Japanese patients with 
      moderate-to-severe RLS, with an acceptable safety profile. Randomized, 
      double-blind, placebo/active-controlled trials are desirable to confirm these 
      preliminary results.
CI  - Copyright (c) 2011 Elsevier Inc. All rights reserved.
FAU - Inoue, Yuichi
AU  - Inoue Y
AD  - Japan Somnology Center, Neuropsychiatric Research Institute, 1-24-10 Yoyogi, 
      Shibuya-ku, Tokyo 151-0053, Japan. inoue@somnology.com
FAU - Uchimura, Naohisa
AU  - Uchimura N
FAU - Kuroda, Kenji
AU  - Kuroda K
FAU - Hirata, Koichi
AU  - Hirata K
FAU - Hattori, Nobutaka
AU  - Hattori N
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20111019
PL  - England
TA  - Prog Neuropsychopharmacol Biol Psychiatry
JT  - Progress in neuro-psychopharmacology & biological psychiatry
JID - 8211617
RN  - 0 (1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic 
      acid)
RN  - 0 (Anticonvulsants)
RN  - 0 (Carbamates)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticonvulsants/adverse effects/*therapeutic use
MH  - Asian People
MH  - Carbamates/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Restless Legs Syndrome/*drug therapy
MH  - Severity of Illness Index
MH  - Sleep Wake Disorders/chemically induced/drug therapy
MH  - Time Factors
MH  - gamma-Aminobutyric Acid/adverse effects/*analogs & derivatives/therapeutic use
EDAT- 2011/11/01 06:00
MHDA- 2012/05/09 06:00
CRDT- 2011/11/01 06:00
PHST- 2011/07/27 00:00 [received]
PHST- 2011/09/28 00:00 [revised]
PHST- 2011/10/12 00:00 [accepted]
PHST- 2011/11/01 06:00 [entrez]
PHST- 2011/11/01 06:00 [pubmed]
PHST- 2012/05/09 06:00 [medline]
AID - S0278-5846(11)00306-X [pii]
AID - 10.1016/j.pnpbp.2011.10.009 [doi]
PST - ppublish
SO  - Prog Neuropsychopharmacol Biol Psychiatry. 2012 Mar 30;36(2):251-7. doi: 
      10.1016/j.pnpbp.2011.10.009. Epub 2011 Oct 19.