Pregabalin Safe and Effective for Relief of Chronic Neuopathic Pain and Related Sleep Disturbance

New Orleans, LA — According to a randomized, controlled clinical trial reported at the Emerging Science session during the 2012 Annual Meeting of the American Academy of Neurology, pregabalin was found effective in relieving chronic neuropathic pain and pain-related sleep disturbances associated with spinal cord injury. Improvements over placebo were significant for all pain parameters as early as 1 week, and persisted throughout 16 weeks of treatment. The drug was generally well tolerated.

“Neuropathic pain due to spinal cord injury has a substantial negative impact on patient function and quality of life,” said Luis Sanin, MD, Pfizer, Inc, New York City, who presented these study results.

“Pregabalin achieved rapid and meaningful relief of neuropathic pain and related sleep interference associated with spinal cord injury,” he continued.

The 17-week randomized, double-blind, placebo-controlled study enrolled a total of 220 patients from 10 different countries. Patients were selected to receive either a daily dose of 150 to 600 mg of pregabalin, or placebo, in a 1:1 ratio. After a 4-week, flexible-dose adjustment period, patients were treated with their optimal fixed dose of pregabalin or placebo for 12 weeks. Afterward, they were tapered off the drug over a 1-week period.

Outcome measures were evaluated through the Daily Pain Scale and Daily Sleep Interference Scale. Both treatment groups were well balanced for baseline characteristics, with the exception of more males in the placebo group (85.2%) than in the pregabalin group (75.1%). The mean age was about 45 years and the mean duration of central pain was 98 months. About 84% of the patients had persistent central pain over the previous 3 months.

The median treatment duration was 119 days, and the average pregabalin daily dose was 357 mg. Over the full treatment period, the duration-adjusted average change in pain score was significantly greater in the pregabalin-treated patients (P = .003). Changes in the mean pain and pain-related sleep interference score over the study period were also significantly better for the pregabalin-treated group (P = .003 and P <.001, respectively). The percentage of patients who achieved clinically meaningful pain relief (at least a 30% or at least a 50% decrease in mean pain score) at the end of the study was also significantly greater in those who received pregabalin (P <.05 compared with placebo for both comparisons).

Treatment-related adverse events were consistent with those previously reported in studies regarding pregabalin.