title: Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study.
abstract: To evaluate pregabalin's efficacy and safety versus placebo to reduce pain in patients with diabetic peripheral neuropathy (DPN) using a concomitant nonsteroidal anti-inflammatory drug.
  
  
  
  In a randomized, double-masked, 14-week, 2-period, crossover study, patients with painful DPN using a nonsteroidal anti-inflammatory drug for non-DPN-related pain received 150 to 300 mg/d pregabalin or placebo (period 1); 14-day washout; then, the opposite therapy (period 2). Endpoints included weekly change in DPN pain score, sleep interference, adverse events, and patient-reported outcomes.
  
  
  
  Patients with similar baseline characteristics were randomized (period 1) to 1 of the 2 following possible sequences: pregabalin→placebo (n=154) or placebo→pregabalin (n=147). Results of the primary efficacy measure, mean weekly DPN pain at endpoint, showed no significant difference between pregabalin and placebo. However, 1 sensitivity analysis (mixed-model repeated measures) found greater pain score reductions with pregabalin than placebo at weeks 2 to 4 and overall (all P<0.05). One secondary endpoint analysis, mean treatment difference in DPN-related sleep interference, favored pregabalin over placebo (P=0.0009). Other sensitivity and secondary analyses were nonsignificant. Treatment-emergent adverse events were consistent with the known safety profile of pregabalin.
  
  
  
  Pregabalin (vs. placebo) showed overall improvements in sleep, pain reduction in 1 sensitivity analysis, and was well tolerated. Potential factors that may have confounded the ability to detect a treatment difference in DPN pain reduction (high placebo response, carryover effect, short washout period, or pregabalin dose) are discussed in the context of future studies.
authors.affiliation: *Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX †Meridien Research, Tampa, FL ‡Pfizer Inc., Groton, CT §Pfizer Inc., New York, NY.
authors.forename: Philip
authors.initials: P
authors.lastname: Raskin
authors.forename: Cynthia
authors.initials: C
authors.lastname: Huffman
authors.forename: Lorraine
authors.initials: L
authors.lastname: Yurkewicz
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Scavone
authors.forename: Ruoyong
authors.initials: R
authors.lastname: Yang
authors.forename: Bruce
authors.initials: B
authors.lastname: Parsons
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D018592:Cross-Over Studies; D018153:Czech Republic; D003929:Diabetic Neuropathies / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000175:diagnosis / Q000188:drug therapy*; D010147:Pain Measurement / Q000187:drug effects*; D000069583:Pregabalin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014481:United States
chemical_list: D000700:Analgesics; D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000069583:Pregabalin