title: Evaluation of Quality of Life in Patients With Narcolepsy Treated With Sodium Oxybate: Use of the 36-Item Short-Form Health Survey in a Clinical Trial.
abstract: BACKGROUND
  The present post hoc analysis was designed to evaluate health-related quality of life (HRQoL) using the 36-item Short Form Health Status Survey (SF-36) during an 8-week trial of sodium oxybate (SXB).
  
  
  METHODS
  SF-36 was assessed in a phase 3 placebo-controlled trial in patients with narcolepsy (N = 228) randomized to placebo or SXB in doses of 4.5, 6, or 9 g nightly for 8 weeks. Changes from baseline in SF-36 (last observation carried forward) were compared between SXB and placebo, and effect sizes (ES) were estimated.
  
  
  RESULTS
  Baseline SF-36 values were lower than normative values for the US general population. After 8 weeks of treatment, mean (±standard deviation) improvement from baseline on the Physical Component Summary (PCS) was significantly greater with SXB 9 g/night than placebo (6.3 ± 9.1 vs. 1.5 ± 6.2; p = 0.005), with moderate ES; no significant difference was found between the SXB and placebo groups on the Mental Component Summary. SXB 9 g/night resulted in significantly (p < 0.05) greater improvements than placebo in Physical Functioning (4.4 ± 9.2 vs. 1.0 ± 8.0), General Health (GH; 3.1 ± 7.0 vs. 0.4 ± 6.8), and Social Functioning (6.8 ± 16.8 vs. 1.1 ± 9.6). All SXB doses resulted in significant improvement (p < 0.05) relative to placebo for Vitality, with moderate ES. No significant differences versus placebo were observed for Role-Physical, Role-Emotional, or Mental Health domains.
  
  
  CONCLUSIONS
  Treatment with SXB was associated with a dose-dependent improvement in HRQoL, with the 9-g nightly dose demonstrating a positive impact on PCS and individual SF-36 domains of Vitality, GH, and Physical and Social Functioning.
  
  
  BACKGROUND
  NCT00049803.
  
  
  BACKGROUND
  Jazz Pharmaceuticals.
authors: Medical University of South Carolina School of Medicine, Charleston, SC, USA. RBogan@sleepmed.md.
authors: Richard
authors: R
authors: Bogan
authors: Neurology and Sleep Medicine Consultants of Houston, University of Texas-Houston School of Medicine, Houston, TX, USA.
authors: Todd
authors: T
authors: Swick
authors: Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
authors: Mortimer
authors: M
authors: Mamelak
authors: Department of Neurology, Sleep Disorders Center, ENH-Evanston Hospital, Evanston, IL, USA.
authors: Ruzica
authors: R
authors: Kovacevic-Ristanovic
authors: Jazz Pharmaceuticals, Palo Alto, CA, USA.
authors: Chinglin
authors: C
authors: Lai
authors: Jazz Pharmaceuticals, Palo Alto, CA, USA.|Stanford Center for Sleep Research and Medicine, Stanford, CA, USA.
authors: Jed
authors: J
authors: Black
authors: Jazz Pharmaceuticals, Palo Alto, CA, USA.
authors: Kathleen F
authors: KF
authors: Villa
authors: Department of Psychiatry, Université de Montréal, Montréal, QC, Canada.
authors: Jacques
authors: J
authors: Montplaisir
keywords: Narcolepsy; Quality of life; SF-36; Sodium oxybate