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Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial.
Eur J Neurol. 2010 Aug; 17(8):1082-9.EJ

Abstract

BACKGROUND

Pregabalin is effective in the treatment of peripheral and central neuropathic pain. This study evaluated pregabalin in the treatment of post-traumatic peripheral neuropathic pain (including post-surgical).

METHODS

Patients with a pain score >or=4 (0-10 scale) were randomized and treated with either flexible-dose pregabalin 150-600 mg/day (n = 127) or placebo (n = 127) in an 8-week double-blind treatment period preceded by a 2-week placebo run-in.

RESULTS

Pregabalin was associated with a significantly greater improvement in the mean end-point pain score vs. placebo; mean treatment difference was -0.62 (95% CI -1.09 to -0.15) (P = 0.01). The average pregabalin dose at end-point was approximately 326 mg/day. Pregabalin was also associated with significant improvements from baseline in pain-related sleep interference, and the Medical Outcomes Study sleep scale sleep problems index and sleep disturbance subscale (all P < 0.001). In the all-patient group (ITT), pregabalin was associated with a statistically significant improvement in the Hospital Anxiety and Depression Scale anxiety subscale (P < 0.05). In total, 29% of patients had moderate/severe baseline anxiety; treatment with pregabalin in this subset did not significantly improve anxiety. More patients reported global improvement at end-point with pregabalin than with placebo (68% vs. 43%; overall P < 0.01). Adverse events led to discontinuation of 20% of patients from pregabalin and 7% from placebo. Mild or moderate dizziness and somnolence were the most common adverse events in the pregabalin group.

CONCLUSION

Flexible-dose pregabalin 150-600 mg/day was effective in relieving neuropathic pain, improving disturbed sleep, improving overall patient status, and was generally well tolerated in patients with post-traumatic peripheral neuropathic pain.

Authors+Show Affiliations

Pain Clinic, Amphia Hospital, Breda, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20236172

Citation

van Seventer, R, et al. "Pregabalin in the Treatment of Post-traumatic Peripheral Neuropathic Pain: a Randomized Double-blind Trial." European Journal of Neurology, vol. 17, no. 8, 2010, pp. 1082-9.
van Seventer R, Bach FW, Toth CC, et al. Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial. Eur J Neurol. 2010;17(8):1082-9.
van Seventer, R., Bach, F. W., Toth, C. C., Serpell, M., Temple, J., Murphy, T. K., & Nimour, M. (2010). Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial. European Journal of Neurology, 17(8), 1082-9. https://doi.org/10.1111/j.1468-1331.2010.02979.x
van Seventer R, et al. Pregabalin in the Treatment of Post-traumatic Peripheral Neuropathic Pain: a Randomized Double-blind Trial. Eur J Neurol. 2010;17(8):1082-9. PubMed PMID: 20236172.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial. AU - van Seventer,R, AU - Bach,F W, AU - Toth,C C, AU - Serpell,M, AU - Temple,J, AU - Murphy,T K, AU - Nimour,M, Y1 - 2010/03/04/ PY - 2010/3/19/entrez PY - 2010/3/20/pubmed PY - 2010/11/3/medline SP - 1082 EP - 9 JF - European journal of neurology JO - Eur J Neurol VL - 17 IS - 8 N2 - BACKGROUND: Pregabalin is effective in the treatment of peripheral and central neuropathic pain. This study evaluated pregabalin in the treatment of post-traumatic peripheral neuropathic pain (including post-surgical). METHODS: Patients with a pain score >or=4 (0-10 scale) were randomized and treated with either flexible-dose pregabalin 150-600 mg/day (n = 127) or placebo (n = 127) in an 8-week double-blind treatment period preceded by a 2-week placebo run-in. RESULTS: Pregabalin was associated with a significantly greater improvement in the mean end-point pain score vs. placebo; mean treatment difference was -0.62 (95% CI -1.09 to -0.15) (P = 0.01). The average pregabalin dose at end-point was approximately 326 mg/day. Pregabalin was also associated with significant improvements from baseline in pain-related sleep interference, and the Medical Outcomes Study sleep scale sleep problems index and sleep disturbance subscale (all P < 0.001). In the all-patient group (ITT), pregabalin was associated with a statistically significant improvement in the Hospital Anxiety and Depression Scale anxiety subscale (P < 0.05). In total, 29% of patients had moderate/severe baseline anxiety; treatment with pregabalin in this subset did not significantly improve anxiety. More patients reported global improvement at end-point with pregabalin than with placebo (68% vs. 43%; overall P < 0.01). Adverse events led to discontinuation of 20% of patients from pregabalin and 7% from placebo. Mild or moderate dizziness and somnolence were the most common adverse events in the pregabalin group. CONCLUSION: Flexible-dose pregabalin 150-600 mg/day was effective in relieving neuropathic pain, improving disturbed sleep, improving overall patient status, and was generally well tolerated in patients with post-traumatic peripheral neuropathic pain. SN - 1468-1331 UR - https://www.unboundmedicine.com/medline/citation/20236172/Pregabalin_in_the_treatment_of_post_traumatic_peripheral_neuropathic_pain:_a_randomized_double_blind_trial_ L2 - https://doi.org/10.1111/j.1468-1331.2010.02979.x DB - PRIME DP - Unbound Medicine ER -