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Neurology and Therapy
Published in: Neurology and Therapy 2/2016

Open Access 01-12-2016 | Original Research

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

Authors: Richard Bogan, Todd Swick, Mortimer Mamelak, Ruzica Kovacevic-Ristanovic, Chinglin Lai, Jed Black, Kathleen F. Villa, Jacques Montplaisir

Published in: Neurology and Therapy | Issue 2/2016

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Abstract

Introduction

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.

Conclusion

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.

Trial registration

NCT00049803.

Funding

Jazz Pharmaceuticals.
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Metadata
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
Authors
Richard Bogan
Todd Swick
Mortimer Mamelak
Ruzica Kovacevic-Ristanovic
Chinglin Lai
Jed Black
Kathleen F. Villa
Jacques Montplaisir
Publication date
01-12-2016
Publisher
Springer Healthcare
Published in
Neurology and Therapy / Issue 2/2016
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI
https://doi.org/10.1007/s40120-016-0053-5

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