title: Treatment response to sleep, pain, and mood disturbance and their correlation with sleep disturbance in adult patients with moderate-to-severe primary restless legs syndrome: Pooled analyses from 3 trials of gabapentin enacarbil.
abstract: BACKGROUND
  This pooled analysis investigated the effects of gabapentin enacarbil (GEn) on clinical correlates of sleep disturbance in adults with moderate-to-severe primary restless legs syndrome (RLS) and no-to-moderate or severe-to-very severe baseline sleep disturbance.
  
  
  METHODS
  Co-primary end-points were mean change from baseline to week 12 in International Restless Legs Scale (IRLS) total score and proportion of responders ('much'/'very much' improved) on the investigator-rated Clinical Global Impression-Improvement (CGI-I) scale (week 12). Pain, mood, individual IRLS items, and safety were assessed.
  
  
  RESULTS
  The modified intent-to-treat population was 671 adults randomized to GEn 600 mg (n = 161), GEn 1200 mg (n = 266), or placebo (n = 244). GEn significantly improved least squares mean change in IRLS total score from baseline versus placebo for no-to-moderate (GEn 600 mg,- 12.3; 1200 mg, - 11.3; placebo, - 7.7) and severe-to-very severe (- 16.6; - 17.0; - 12.7) groups (all P < 0.01). Significantly more GEn-treated patients (both doses) were CGI-I responders (week 12) versus placebo in both sleep subgroups (all P < 0.01). GEn substantially improved mood and pain scores for both sleep subgroups versus placebo. The most frequent treatment-emergent adverse events were somnolence and dizziness.
  
  
  CONCLUSIONS
  GEn (600 mg and 1200 mg) was effective and well tolerated in adults with moderate-to-severe primary RLS regardless of baseline sleep disturbance level.
authors: SleepMed, Private Practice , Columbia, SC , USA.
authors: Richard K
authors: RK
authors: Bogan
authors: Daniel O
authors: DO
authors: Lee
authors: Mark J
authors: MJ
authors: Buchfuhrer
authors: Mark J
authors: MJ
authors: Jaros
authors: Richard
authors: R
authors: Kim
authors: Gwendoline
authors: G
authors: Shang
mesh_terms: D000328:Adult; D002219:Carbamates / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy* / Q000209:etiology; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life; D012148:Restless Legs Syndrome / Q000150:complications* / Q000188:drug therapy; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: C493250:1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid; D002219:Carbamates; D005680:gamma-Aminobutyric Acid
keywords: Gabapentin enacarbil; mood; pain; restless legs syndrome