Efficacy and safety of pregabalin in the treatment of patients with painful diabetic peripheral neuropathy and pain on walking

Cynthia Huffman, Brett R. Stacey, Michael Tuchman, Claire Burbridge, Chunming Li, Bruce Parsons, Lynne Pauer, Joseph M. Scavone, Regina Behar, Lorraine Yurkewicz

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Objectives: This randomized, double-blind, placebo-controlled, multicenter, 2-period crossover study (two 6-week treatment periods separated by a 2-week washout period) evaluated the efficacy and safety of pregabalin (150 to 300 mg/d) for treatment of pain and pain on walking in patients with painful diabetic peripheral neuropathy (DPN) who experienced pain while walking. Methods: Co-primary efficacy endpoints were: (1) mean pain score (last 7 daily pain diary scores, 0 to 10 numeric rating scale at end of each treatment period) and (2) DPN pain on walking (0 to 10 numeric rating scale immediately after walking 50 feet [15.2 m] on flat surface). Secondary endpoints included other pain parameters, patient-reported sleep, health-related quality of life, and safety measures. Results: Two hundred three patients were treated (pregabalin, n=198; placebo, n=186), with no statistically significant treatment difference for pregabalin versus placebo in the co-primary efficacy endpoints, mean DPN pain (P=0.0656) and mean DPN pain on walking (P=0.412). A carryover effect was observed. Analysis of co-primary endpoints for period 1 showed significant treatment difference for DPN pain (P=0.034) and DPN pain on walking (P=0.001). Treatment with pregabalin resulted in significant improvements versus placebo on prespecified patient global impression of change (end of period 1; P=0.002), and sleep interference rating scale (end of period 2; P=0.011). Adverse events were more frequent with pregabalin than with placebo and caused discontinuation in 13 (6.6%) pregabalin patients versus 5 (2.7%) placebo patients. Discussion: Failure to meet the co-primary objectives may be related to carryover effect from period 1 to period 2, lower pregabalin dose (150 to 300 mg/d), and/or placebo response in painful DPN.

Original languageEnglish (US)
Pages (from-to)946-958
Number of pages13
JournalClinical Journal of Pain
Issue number11
StatePublished - Jan 1 2015


  • Carryover effect
  • Pain on walking
  • Painful diabetic peripheral neuropathy
  • Pregabalin
  • Randomized trial

ASJC Scopus subject areas

  • Clinical Neurology
  • Anesthesiology and Pain Medicine


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