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Safety and efficacy of pregabalin in patients with central post-stroke pain.
Pain. 2011 May; 152(5):1018-23.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.

Authors+Show Affiliations

Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, South Korea. jongskim@amc.seoul.krNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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), 1018-23. https://doi.org/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 -