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Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial.
Clin J Pain 2014; 30(5):379-90CJ

Abstract

OBJECTIVES

This study used a randomized withdrawal design to evaluate the efficacy of pregabalin versus placebo for pain relief in patients with painful diabetic peripheral neuropathy inadequately treated by other therapies.

METHODS

A total of 665 patients received pregabalin in a 6-week single-blind phase. Two hundred ninety-four patients who achieved a ≥ 30% pain response were randomized to receive pregabalin or placebo in a double-blind phase for a further 13 weeks. The primary endpoint was the change in mean pain score from single-blind baseline to double-blind endpoint for pregabalin versus placebo (last observation carried forward [LOCF]). Secondary endpoints included a baseline observation carried forward (BOCF) analysis of mean pain score; time to loss of pain response; and other assessments of pain, sleep, function, and quality of life (QOL).

RESULTS

Pregabalin numerically improved all measures assessed during the single-blind phase. At the end of the double-blind withdrawal phase, there was no significant difference in the primary endpoint of mean pain score (LOCF) between pregabalin and placebo (least squares mean difference, -0.32), although there was a significant difference in the BOCF analysis (least squares mean difference, -0.51). Pregabalin was associated with a significantly longer time to loss of pain response versus placebo during double-blind treatment, and some aspects of sleep and QOL also showed significant improvements with pregabalin.

DISCUSSION

This is the first reported placebo-controlled trial of pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy. Although the primary endpoint was not met, pregabalin was associated with clinically relevant improvements versus placebo in this difficult-to-treat population.

Authors+Show Affiliations

*Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX †Meridien Research, Tampa, FL §Pfizer Inc, New York, NY ‡Department of Clinical Neurosciences, The University of Calgary, Calgary, AB, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23887339

Citation

Raskin, Philip, et al. "Pregabalin in Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy: a Randomized Withdrawal Trial." The Clinical Journal of Pain, vol. 30, no. 5, 2014, pp. 379-90.
Raskin P, Huffman C, Toth C, et al. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014;30(5):379-90.
Raskin, P., Huffman, C., Toth, C., Asmus, M. J., Messig, M., Sanchez, R. J., & Pauer, L. (2014). Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. The Clinical Journal of Pain, 30(5), pp. 379-90. doi:10.1097/AJP.0b013e31829ea1a1.
Raskin P, et al. Pregabalin in Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy: a Randomized Withdrawal Trial. Clin J Pain. 2014;30(5):379-90. PubMed PMID: 23887339.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. AU - Raskin,Philip, AU - Huffman,Cynthia, AU - Toth,Cory, AU - Asmus,Michael J, AU - Messig,Michael, AU - Sanchez,Robert J, AU - Pauer,Lynne, PY - 2013/7/27/entrez PY - 2013/7/28/pubmed PY - 2014/12/15/medline SP - 379 EP - 90 JF - The Clinical journal of pain JO - Clin J Pain VL - 30 IS - 5 N2 - OBJECTIVES: This study used a randomized withdrawal design to evaluate the efficacy of pregabalin versus placebo for pain relief in patients with painful diabetic peripheral neuropathy inadequately treated by other therapies. METHODS: A total of 665 patients received pregabalin in a 6-week single-blind phase. Two hundred ninety-four patients who achieved a ≥ 30% pain response were randomized to receive pregabalin or placebo in a double-blind phase for a further 13 weeks. The primary endpoint was the change in mean pain score from single-blind baseline to double-blind endpoint for pregabalin versus placebo (last observation carried forward [LOCF]). Secondary endpoints included a baseline observation carried forward (BOCF) analysis of mean pain score; time to loss of pain response; and other assessments of pain, sleep, function, and quality of life (QOL). RESULTS: Pregabalin numerically improved all measures assessed during the single-blind phase. At the end of the double-blind withdrawal phase, there was no significant difference in the primary endpoint of mean pain score (LOCF) between pregabalin and placebo (least squares mean difference, -0.32), although there was a significant difference in the BOCF analysis (least squares mean difference, -0.51). Pregabalin was associated with a significantly longer time to loss of pain response versus placebo during double-blind treatment, and some aspects of sleep and QOL also showed significant improvements with pregabalin. DISCUSSION: This is the first reported placebo-controlled trial of pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy. Although the primary endpoint was not met, pregabalin was associated with clinically relevant improvements versus placebo in this difficult-to-treat population. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/23887339/Pregabalin_in_patients_with_inadequately_treated_painful_diabetic_peripheral_neuropathy:_a_randomized_withdrawal_trial_ L2 - http://dx.doi.org/10.1097/AJP.0b013e31829ea1a1 DB - PRIME DP - Unbound Medicine ER -