Pregabalin in patients with painful diabetic peripheral neuropathy using an NSAID for other pain conditions a double-blind crossover study

Philip Raskin, Cynthia Huffman, Lorraine Yurkewicz, Lynne Pauer, Joseph M. Scavone, Ruoyong Yang, Bruce Parsons

Research output: Contribution to journalArticle

14 Scopus citations

Abstract

Objectives: 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. Materials and Methods: 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. Results: Patients with similar baseline characteristics were randomized (period 1) to 1 of the 2 following possible sequences: pregabalinplacebo (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

Original languageEnglish (US)
Pages (from-to)203-210
Number of pages8
JournalClinical Journal of Pain
Volume32
Issue number3
DOIs
StatePublished - 2016

Keywords

  • Crossover trial
  • Diabetic peripheral neuropathy
  • Nonsteroidal anti-inflammatory drug
  • Pain
  • Pregabalin

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Clinical Neurology

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