Pregabalin does not appear to be effective for controlling pain in patients with chronic post-traumatic peripheral neuropathic pain (PTNP), according to a study published in the Journal of Neurology.
Pregabalin, an alpha2-delta ligand, is approved in the US for the treatment of neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury, and for postherpetic neuralgia. In this 15-week, Phase 3, double-blind, placebo-controlled trial, a total of 539 PTNP patients were randomized to receive pregabalin (N=274, flexibly dosed 150–600mg/day) or placebo (N=265). The primary outcome measure was pain rated in a diary completed by telephone each evening; secondary outcomes included measures of overall status, pain-related activity limitation, and sleep.
Results showed that pain scores did improve in both groups compared with baseline (-2.12 for pregabalin and -1.90 for placebo) but primary efficacy analysis showed no statistically significant difference between both groups in change from baseline to week 15 (mean difference: -0.22; 95% CI -0.54–0.10; P=.1823). “However, comparisons for key secondary outcome measures (ie, Brief Pain Inventory-Short Form) yielded P values <.05 favoring pregabalin,” noted the authors. With regard to safety, the most common adverse events reported were dizziness and somnolence.
Based on these findings, the authors concluded that, “The efficacy of pregabalin in PTNP merits further study in light of promising findings in clinically relevant outcomes, the low rate of [serious adverse events], the positive results of a previous trial, established efficacy in other chronic [neuropathic pain] syndromes, and the lack of evidence-based treatments for PTNP.”
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