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Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial.
Neurology 2006; 67(10):1792-800Neur

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.

Authors+Show Affiliations

Pain Management and Research Institute, University of Sydney, Royal North Shore Hospital, Sydney, NSW, 2065, Australia. phils@med.usyd.edu.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 -