Sodium oxybate therapy provides multidimensional improvement in fi bromyalgia

Results of an international phase 3 trial

Michael Spaeth, Robert (Rob) Bennett, Beverly A. Benson, Y. Grace Wang, Chinglin Lai, Ernest H. Choy

    Research output: Contribution to journalArticle

    24 Citations (Scopus)

    Abstract

    Background: Fibromyalgia is characterised by chronic musculoskeletal pain and multiple symptoms including fatigue, multidimensional function impairment, sleep disturbance and tenderness. Along with pain and fatigue, non-restorative sleep is a core symptom of fi bromyalgia. Sodium oxybate (SXB) is thought to reduce non-restorative sleep abnormalities. This study evaluated effects of SXB on fi bromyalgia-related pain and other symptoms. Methods: 573 patients with fi bromyalgia according to 1990 American College of Rheumatology criteria were enrolled at 108 centres in eight countries. Subjects were randomly assigned to placebo, SXB 4.5 g/night or SXB 6 g/night. The primary efficacy endpoint was the proportion of subjects with ≥30% reduction in pain visual analogue scale from baseline to treatment end. Other efficacy assessments included function, sleep quality, effect of sleep on function, fatigue, tenderness, healthrelated quality of life and subject's impression of change in overall wellbeing. Results: Significant improvements in pain, sleep and other symptoms associated with fi bromyalgia were seen in SXB treated subjects compared with placebo. The proportion of subjects with ≥30% pain reduction was 42.0% for SXB4.5 g/night (p=0.002) and 51.4% for SXB6 g/night (p

    Original languageEnglish (US)
    Pages (from-to)935-942
    Number of pages8
    JournalAnnals of the Rheumatic Diseases
    Volume71
    Issue number6
    DOIs
    StatePublished - Jun 2012

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    Sodium Oxybate
    Sleep
    Fatigue
    Pain
    Fatigue of materials
    Therapeutics
    Placebos
    Musculoskeletal Pain
    Fibromyalgia
    Pain Measurement
    Chronic Pain
    Quality of Life

    ASJC Scopus subject areas

    • Rheumatology
    • Immunology
    • Biochemistry, Genetics and Molecular Biology(all)
    • Immunology and Allergy

    Cite this

    Sodium oxybate therapy provides multidimensional improvement in fi bromyalgia : Results of an international phase 3 trial. / Spaeth, Michael; Bennett, Robert (Rob); Benson, Beverly A.; Wang, Y. Grace; Lai, Chinglin; Choy, Ernest H.

    In: Annals of the Rheumatic Diseases, Vol. 71, No. 6, 06.2012, p. 935-942.

    Research output: Contribution to journalArticle

    Spaeth, Michael ; Bennett, Robert (Rob) ; Benson, Beverly A. ; Wang, Y. Grace ; Lai, Chinglin ; Choy, Ernest H. / Sodium oxybate therapy provides multidimensional improvement in fi bromyalgia : Results of an international phase 3 trial. In: Annals of the Rheumatic Diseases. 2012 ; Vol. 71, No. 6. pp. 935-942.
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    abstract = "Background: Fibromyalgia is characterised by chronic musculoskeletal pain and multiple symptoms including fatigue, multidimensional function impairment, sleep disturbance and tenderness. Along with pain and fatigue, non-restorative sleep is a core symptom of fi bromyalgia. Sodium oxybate (SXB) is thought to reduce non-restorative sleep abnormalities. This study evaluated effects of SXB on fi bromyalgia-related pain and other symptoms. Methods: 573 patients with fi bromyalgia according to 1990 American College of Rheumatology criteria were enrolled at 108 centres in eight countries. Subjects were randomly assigned to placebo, SXB 4.5 g/night or SXB 6 g/night. The primary efficacy endpoint was the proportion of subjects with ≥30{\%} reduction in pain visual analogue scale from baseline to treatment end. Other efficacy assessments included function, sleep quality, effect of sleep on function, fatigue, tenderness, healthrelated quality of life and subject's impression of change in overall wellbeing. Results: Significant improvements in pain, sleep and other symptoms associated with fi bromyalgia were seen in SXB treated subjects compared with placebo. The proportion of subjects with ≥30{\%} pain reduction was 42.0{\%} for SXB4.5 g/night (p=0.002) and 51.4{\%} for SXB6 g/night (p",
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