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Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking.
Clin J Pain. 2015 11; 31(11):946-58.CJ

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

DISCUSSION

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+Show Affiliations

*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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

25565583

Citation

Huffman, Cynthia, et al. "Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain On Walking." The Clinical Journal of Pain, vol. 31, no. 11, 2015, pp. 946-58.
Huffman C, Stacey BR, Tuchman M, et al. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015;31(11):946-58.
Huffman, C., Stacey, B. R., Tuchman, M., Burbridge, C., Li, C., Parsons, B., Pauer, L., Scavone, J. M., Behar, R., & Yurkewicz, L. (2015). Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. The Clinical Journal of Pain, 31(11), 946-58. https://doi.org/10.1097/AJP.0000000000000198
Huffman C, et al. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain On Walking. Clin J Pain. 2015;31(11):946-58. PubMed PMID: 25565583.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. AU - Huffman,Cynthia, AU - Stacey,Brett R, AU - Tuchman,Michael, AU - Burbridge,Claire, AU - Li,Chunming, AU - Parsons,Bruce, AU - Pauer,Lynne, AU - Scavone,Joseph M, AU - Behar,Regina, AU - Yurkewicz,Lorraine, PY - 2015/1/8/entrez PY - 2015/1/8/pubmed PY - 2016/7/2/medline SP - 946 EP - 58 JF - The Clinical journal of pain JO - Clin J Pain VL - 31 IS - 11 N2 - OBJECTIVES: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/25565583/Efficacy_and_Safety_of_Pregabalin_in_the_Treatment_of_Patients_With_Painful_Diabetic_Peripheral_Neuropathy_and_Pain_on_Walking_ L2 - https://doi.org/10.1097/AJP.0000000000000198 DB - PRIME DP - Unbound Medicine ER -