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Safety and efficacy of pregabalin in patients with central post-stroke pain.

Abstract

Pregabalin has demonstrated efficacy in several forms of neuropathic pain, but its long-term efficacy in central post-stroke pain (CPSP) is unproven. We evaluated the efficacy and safety of pregabalin versus placebo in patients with CPSP. A 13-week, randomized, double-blind, multicenter, placebo-controlled, parallel group study of 150 to 600 mg/day pregabalin was conducted in patients aged ≥18 years with CPSP. The primary efficacy endpoint was the mean pain score on the Daily Pain Rating Scale over the last 7 days on study drug up to week 12 or early termination visit. Secondary endpoints included other pain parameters and patient-reported sleep and health-related quality-of-life measures. A total of 219 patients were treated (pregabalin n=110; placebo n=109). A mean pain score at baseline of 6.5 in the pregabalin group and 6.3 in the placebo group reduced at endpoint to 4.9 in the pregabalin group and 5.0 in the placebo group (LS mean difference=-0.2; 95% CI=-0.7, 0.4; P=0.578). Treatment with pregabalin resulted in significant improvements, compared with placebo, on secondary endpoints including MOS-sleep, HADS-A anxiety, and clinician global impression of change (CGIC) P<0.05. Adverse events were more frequent with pregabalin than with placebo and caused discontinuation in 9 (8.2%) of pregabalin patients versus 4 (3.7%) of placebo patients. Although pain reductions at endpoint did not differ significantly between pregabalin and placebo, improvements in sleep, anxiety, and CGIC suggest some utility of pregabalin in the management of CPSP.

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  • Authors+Show Affiliations

    ,

    Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, South Korea. jongskim@amc.seoul.kr

    , , , ,

    Source

    Pain 152:5 2011 May pg 1018-23

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Analgesics
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Pain
    Pain Measurement
    Pregabalin
    Stroke
    Treatment Outcome
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    21316855

    Citation

    Kim, Jong S., et al. "Safety and Efficacy of Pregabalin in Patients With Central Post-stroke Pain." Pain, vol. 152, no. 5, 2011, pp. 1018-23.
    Kim JS, Bashford G, Murphy TK, et al. Safety and efficacy of pregabalin in patients with central post-stroke pain. Pain. 2011;152(5):1018-23.
    Kim, J. S., Bashford, G., Murphy, T. K., Martin, A., Dror, V., & Cheung, R. (2011). Safety and efficacy of pregabalin in patients with central post-stroke pain. Pain, 152(5), pp. 1018-23. doi:10.1016/j.pain.2010.12.023.
    Kim JS, et al. Safety and Efficacy of Pregabalin in Patients With Central Post-stroke Pain. Pain. 2011;152(5):1018-23. PubMed PMID: 21316855.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Safety and efficacy of pregabalin in patients with central post-stroke pain. AU - Kim,Jong S, AU - Bashford,Guy, AU - Murphy,T Kevin, AU - Martin,Andrew, AU - Dror,Vardit, AU - Cheung,Raymond, Y1 - 2011/02/12/ PY - 2010/03/17/received PY - 2010/11/08/revised PY - 2010/12/14/accepted PY - 2011/2/15/entrez PY - 2011/2/15/pubmed PY - 2011/8/24/medline SP - 1018 EP - 23 JF - Pain JO - Pain VL - 152 IS - 5 N2 - Pregabalin has demonstrated efficacy in several forms of neuropathic pain, but its long-term efficacy in central post-stroke pain (CPSP) is unproven. We evaluated the efficacy and safety of pregabalin versus placebo in patients with CPSP. A 13-week, randomized, double-blind, multicenter, placebo-controlled, parallel group study of 150 to 600 mg/day pregabalin was conducted in patients aged ≥18 years with CPSP. The primary efficacy endpoint was the mean pain score on the Daily Pain Rating Scale over the last 7 days on study drug up to week 12 or early termination visit. Secondary endpoints included other pain parameters and patient-reported sleep and health-related quality-of-life measures. A total of 219 patients were treated (pregabalin n=110; placebo n=109). A mean pain score at baseline of 6.5 in the pregabalin group and 6.3 in the placebo group reduced at endpoint to 4.9 in the pregabalin group and 5.0 in the placebo group (LS mean difference=-0.2; 95% CI=-0.7, 0.4; P=0.578). Treatment with pregabalin resulted in significant improvements, compared with placebo, on secondary endpoints including MOS-sleep, HADS-A anxiety, and clinician global impression of change (CGIC) P<0.05. Adverse events were more frequent with pregabalin than with placebo and caused discontinuation in 9 (8.2%) of pregabalin patients versus 4 (3.7%) of placebo patients. Although pain reductions at endpoint did not differ significantly between pregabalin and placebo, improvements in sleep, anxiety, and CGIC suggest some utility of pregabalin in the management of CPSP. SN - 1872-6623 UR - https://www.unboundmedicine.com/medline/citation/21316855/Safety_and_efficacy_of_pregabalin_in_patients_with_central_post_stroke_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304-3959(10)00773-6 DB - PRIME DP - Unbound Medicine ER -