title: Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: *Meridien Research, Tampa, FL †Oregon Health & Science University, Portland, OR ‡Palm Beach Neurological Center, Palm Beach Gardens, FL §Pfizer Ltd, Tadworth, Surrey, UK ∥Pfizer Inc., New York, NY ¶Pfizer Inc., Groton, CT.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Huffman
authors.forename: Brett R
authors.initials: BR
authors.lastname: Stacey
authors.forename: Michael
authors.initials: M
authors.lastname: Tuchman
authors.forename: Claire
authors.initials: C
authors.lastname: Burbridge
authors.forename: Chunming
authors.initials: C
authors.lastname: Li
authors.forename: Bruce
authors.initials: B
authors.lastname: Parsons
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Scavone
authors.forename: Regina
authors.initials: R
authors.lastname: Behar
authors.forename: Lorraine
authors.initials: L
authors.lastname: Yurkewicz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D000069583:Pregabalin / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology
chemical_list: D000700:Analgesics; D000069583:Pregabalin