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Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial.

Abstract

OBJECTIVE

To evaluate pregabalin in central neuropathic pain associated with spinal cord injury.

METHODS

A 12-week, multicenter study of patients randomized to either flexible-dose pregabalin 150 to 600 mg/day (n = 70) or placebo (n = 67), administered BID. Patients were allowed to remain on existing, stable pain therapy. The primary efficacy variable was the endpoint mean pain score, derived from patients' last 7 days daily pain diary entries. Key secondary endpoints included pain responder rates, the SF-MPQ, sleep interference, mood, and the patient global measure of change.

RESULTS

The mean baseline pain score was 6.54 in the pregabalin group and 6.73 in the placebo group. The mean endpoint pain score was lower in the pregabalin group (4.62) than the placebo group (6.27; p < 0.001), with efficacy observed as early as week 1 and maintained for the duration of the study. The average pregabalin dose after the 3-week stabilization phase was 460 mg/day. Pregabalin was significantly superior to placebo in endpoint assessments on the SF-MPQ. The > or =30% and > or =50% pain responder rates were higher with pregabalin than placebo (p < 0.05). Pregabalin was associated with improvements in disturbed sleep (p < 0.001) and anxiety (p < 0.05), and more patients reported global improvement at endpoint in the pregabalin group (p < 0.001). Mild or moderate, typically transient, somnolence and dizziness were the most common adverse events.

CONCLUSIONS

Pregabalin 150 to 600 mg/day was effective in relieving central neuropathic pain, improving sleep, anxiety, and overall patient status in patients with spinal cord injury.

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  • Authors+Show Affiliations

    ,

    Pain Management and Research Institute, University of Sydney, Royal North Shore Hospital, Sydney, NSW, 2065, Australia. phils@med.usyd.edu.au

    , , , ,

    Source

    Neurology 67:10 2006 Nov 28 pg 1792-800

    MeSH

    Adult
    Affect
    Aged
    Aged, 80 and over
    Analgesics
    Anxiety
    Disability Evaluation
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Neuralgia
    Pain Measurement
    Pain Threshold
    Pain, Intractable
    Placebos
    Pregabalin
    Sleep Initiation and Maintenance Disorders
    Spinal Cord Injuries
    Treatment Outcome
    gamma-Aminobutyric Acid

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    17130411

    Citation

    Siddall, P J., et al. "Pregabalin in Central Neuropathic Pain Associated With Spinal Cord Injury: a Placebo-controlled Trial." Neurology, vol. 67, no. 10, 2006, pp. 1792-800.
    Siddall PJ, Cousins MJ, Otte A, et al. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology. 2006;67(10):1792-800.
    Siddall, P. J., Cousins, M. J., Otte, A., Griesing, T., Chambers, R., & Murphy, T. K. (2006). Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology, 67(10), pp. 1792-800.
    Siddall PJ, et al. Pregabalin in Central Neuropathic Pain Associated With Spinal Cord Injury: a Placebo-controlled Trial. Neurology. 2006 Nov 28;67(10):1792-800. PubMed PMID: 17130411.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. AU - Siddall,P J, AU - Cousins,M J, AU - Otte,A, AU - Griesing,T, AU - Chambers,R, AU - Murphy,T K, PY - 2006/11/30/pubmed PY - 2006/12/28/medline PY - 2006/11/30/entrez SP - 1792 EP - 800 JF - Neurology JO - Neurology VL - 67 IS - 10 N2 - OBJECTIVE: To evaluate pregabalin in central neuropathic pain associated with spinal cord injury. METHODS: A 12-week, multicenter study of patients randomized to either flexible-dose pregabalin 150 to 600 mg/day (n = 70) or placebo (n = 67), administered BID. Patients were allowed to remain on existing, stable pain therapy. The primary efficacy variable was the endpoint mean pain score, derived from patients' last 7 days daily pain diary entries. Key secondary endpoints included pain responder rates, the SF-MPQ, sleep interference, mood, and the patient global measure of change. RESULTS: The mean baseline pain score was 6.54 in the pregabalin group and 6.73 in the placebo group. The mean endpoint pain score was lower in the pregabalin group (4.62) than the placebo group (6.27; p < 0.001), with efficacy observed as early as week 1 and maintained for the duration of the study. The average pregabalin dose after the 3-week stabilization phase was 460 mg/day. Pregabalin was significantly superior to placebo in endpoint assessments on the SF-MPQ. The > or =30% and > or =50% pain responder rates were higher with pregabalin than placebo (p < 0.05). Pregabalin was associated with improvements in disturbed sleep (p < 0.001) and anxiety (p < 0.05), and more patients reported global improvement at endpoint in the pregabalin group (p < 0.001). Mild or moderate, typically transient, somnolence and dizziness were the most common adverse events. CONCLUSIONS: Pregabalin 150 to 600 mg/day was effective in relieving central neuropathic pain, improving sleep, anxiety, and overall patient status in patients with spinal cord injury. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/17130411/Pregabalin_in_central_neuropathic_pain_associated_with_spinal_cord_injury:_a_placebo_controlled_trial_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&amp;pmid=17130411 DB - PRIME DP - Unbound Medicine ER -