A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury

被引:148
作者
Cardenas, Diana D. [1 ]
Nieshoff, Edward C. [2 ]
Suda, Kota [4 ]
Goto, Shin-ichi [5 ]
Sanin, Luis [3 ]
Kaneko, Takehiko [6 ]
Sporn, Jonathan [3 ]
Parsons, Bruce [3 ]
Soulsby, Matt [6 ,7 ]
Yang, Ruoyong [3 ]
Whalen, Ed [3 ]
Scavone, Joseph M. [8 ]
Suzuki, Makoto M.
Knapp, Lloyd E. [8 ]
机构
[1] Univ Miami, Leonard M Miller Sch Med, Dept Rehabil Med, Coral Gables, FL 33124 USA
[2] Wayne State Univ, Detroit, MI USA
[3] Pfizer Inc, New York, NY USA
[4] Hokkaido Chuo Rosai Hosp, Spinal Cord Injury Ctr, Bibai, Hokkaido, Japan
[5] Senboku Kumiai Gen Hosp, Daisen, Akita, Japan
[6] Pfizer Japan, Shibuya Ku, Tokyo, Japan
[7] UBC Sci Solut, Southport, CT USA
[8] Pfizer Inc, Groton, CT 06340 USA
关键词
PHARMACOLOGICAL-TREATMENTS; MANAGEMENT; MECHANISMS; EFFICACY; SCALE;
D O I
10.1212/WNL.0b013e318281546b
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Objective: To assess the efficacy and tolerability of pregabalin for the treatment of central neuropathic pain after spinal cord injury (SCI). Methods: Patients with chronic, below-level, neuropathic pain due to SCI were randomized to receive 150 to 600 mg/d pregabalin (n = 108) or matching placebo (n = 112) for 17 weeks. Pain was classified in relation to the neurologic level of injury, defined as the most caudal spinal cord segment with normal sensory and motor function, as above, at, or below level. The primary outcome measure was duration-adjusted average change in pain. Key secondary outcome measures included the change in mean pain score from baseline to end point, the percentage of patients with >= 30% reduction in mean pain score at end point, Patient Global Impression of Change scores at end point, and the change in mean pain-related sleep interference score from baseline to end point. Additional outcome measures included the Medical Outcomes Study-Sleep Scale and the Hospital Anxiety and Depression Scale. Results: Pregabalin treatment resulted in statistically significant improvements over placebo for all primary and key secondary outcome measures. Significant pain improvement was evident as early as week 1 and was sustained throughout the treatment period. Adverse events were consistent with the known safety profile of pregabalin and weremostly mild tomoderate in severity. Somnolence and dizziness were most frequently reported. Conclusions: This study demonstrates that pregabalin is effective and well tolerated in patients with neuropathic pain due to SCI. Classification of evidence: This study provides Class I evidence that pregabalin, 150 to 600 mg/d, is effective in reducing duration-adjusted average change in pain compared with baseline in patients with SCI over a 16-week period (p = 0.003, 95% confidence interval = -0.98, -0.20). Neurology (R) 2013;80:533-539
引用
收藏
页码:533 / 539
页数:7
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