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Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study.
Clin J Pain 2016; 32(3):203-10CJ

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: 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.

DISCUSSION

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+Show Affiliations

*Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX †Meridien Research, Tampa, FL ‡Pfizer Inc., Groton, CT §Pfizer Inc., New York, NY.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25968451

Citation

Raskin, Philip, et al. "Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: a Double-Blind Crossover Study." The Clinical Journal of Pain, vol. 32, no. 3, 2016, pp. 203-10.
Raskin P, Huffman C, Yurkewicz L, et al. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. Clin J Pain. 2016;32(3):203-10.
Raskin, P., Huffman, C., Yurkewicz, L., Pauer, L., Scavone, J. M., Yang, R., & Parsons, B. (2016). Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. The Clinical Journal of Pain, 32(3), pp. 203-10. doi:10.1097/AJP.0000000000000254.
Raskin P, et al. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: a Double-Blind Crossover Study. Clin J Pain. 2016;32(3):203-10. PubMed PMID: 25968451.
* Article titles in AMA citation format should be in sentence-case
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 - 2015/5/14/entrez PY - 2015/5/15/pubmed PY - 2016/11/1/medline SP - 203 EP - 10 JF - The Clinical journal of pain JO - Clin J Pain VL - 32 IS - 3 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: 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. DISCUSSION: 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. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/25968451/Pregabalin_in_Patients_With_Painful_Diabetic_Peripheral_Neuropathy_Using_an_NSAID_for_Other_Pain_Conditions:_A_Double_Blind_Crossover_Study_ L2 - http://dx.doi.org/10.1097/AJP.0000000000000254 DB - PRIME DP - Unbound Medicine ER -