TY - JOUR
T1 - Pregabalin in patients with painful diabetic peripheral neuropathy using an NSAID for other pain conditions a double-blind crossover study
AU - Raskin, Philip
AU - Huffman, Cynthia
AU - Yurkewicz, Lorraine
AU - Pauer, Lynne
AU - Scavone, Joseph M.
AU - Yang, Ruoyong
AU - Parsons, Bruce
PY - 2016
Y1 - 2016
N2 - 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
AB - 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
KW - Crossover trial
KW - Diabetic peripheral neuropathy
KW - Nonsteroidal anti-inflammatory drug
KW - Pain
KW - Pregabalin
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U2 - 10.1097/AJP.0000000000000254
DO - 10.1097/AJP.0000000000000254
M3 - Article
C2 - 25968451
AN - SCOPUS:84957879208
SN - 0749-8047
VL - 32
SP - 203
EP - 210
JO - Clinical Journal of Pain
JF - Clinical Journal of Pain
IS - 3
ER -