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Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.

Abstract

This was a 6-week, randomized, double-blind, multicenter study evaluating the efficacy of pregabalin in the treatment of painful diabetic neuropathy. Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo. The primary efficacy variable was mean pain score at the end of treatment. Efficacy results indicate that pregabalin 600 mg/day significantly decreased mean pain score to 4.3 (vs 5.6 for placebo, P = .0002) and increased the proportion of patients who had a > or =50% decrease from baseline pain (39% vs 15% for placebo, P = .002). Pregabalin also significantly reduced sleep interference, past week and present pain intensity, sensory and affective pain scores, and bodily pain and decreased by > or =50% the number of patients describing their pain as gnawing, sickening, fearful, and punishing-cruel. More patients receiving pregabalin 600 mg/day than placebo showed improvement, as rated on the Clinical and Patient Global Impression of Change scales, 73% vs 45% and 85% vs 47%, respectively. Pregabalin 150 mg/day was essentially no different from placebo. Dizziness was the most common side effect. These study results show pregabalin 600 mg/day to be safe and effective in reducing the pain and other associated symptoms of painful diabetic neuropathy.

PERSPECTIVE

Painful diabetic peripheral neuropathy is a challenging neuropathic pain syndrome. This randomized controlled trial demonstrates that pregabalin, a new drug that interacts with the alpha2-delta protein subunit of the voltage-gated calcium channel, is an efficacious and safe treatment for the pain of this condition.

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  • Authors+Show Affiliations

    ,

    Neurology Department, St John Medical Center, Tulsa, Oklahoma, USA.

    , , , ,

    Source

    MeSH

    Aged
    Analgesia
    Analgesics
    Anticonvulsants
    Calcium Channel Blockers
    Calcium Channels
    Diabetic Neuropathies
    Dizziness
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Pain Measurement
    Placebo Effect
    Placebos
    Pregabalin
    Sleep Initiation and Maintenance Disorders
    Stress, Psychological
    Treatment Outcome
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15820913

    Citation

    Richter, Ralph W., et al. "Relief of Painful Diabetic Peripheral Neuropathy With Pregabalin: a Randomized, Placebo-controlled Trial." The Journal of Pain : Official Journal of the American Pain Society, vol. 6, no. 4, 2005, pp. 253-60.
    Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6(4):253-60.
    Richter, R. W., Portenoy, R., Sharma, U., Lamoreaux, L., Bockbrader, H., & Knapp, L. E. (2005). Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. The Journal of Pain : Official Journal of the American Pain Society, 6(4), pp. 253-60.
    Richter RW, et al. Relief of Painful Diabetic Peripheral Neuropathy With Pregabalin: a Randomized, Placebo-controlled Trial. J Pain. 2005;6(4):253-60. PubMed PMID: 15820913.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. AU - Richter,Ralph W, AU - Portenoy,Russell, AU - Sharma,Uma, AU - Lamoreaux,Linda, AU - Bockbrader,Howard, AU - Knapp,Lloyd E, PY - 2004/03/12/received PY - 2004/12/17/revised PY - 2004/12/23/accepted PY - 2005/4/12/pubmed PY - 2005/7/30/medline PY - 2005/4/12/entrez SP - 253 EP - 60 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 6 IS - 4 N2 - UNLABELLED: This was a 6-week, randomized, double-blind, multicenter study evaluating the efficacy of pregabalin in the treatment of painful diabetic neuropathy. Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo. The primary efficacy variable was mean pain score at the end of treatment. Efficacy results indicate that pregabalin 600 mg/day significantly decreased mean pain score to 4.3 (vs 5.6 for placebo, P = .0002) and increased the proportion of patients who had a > or =50% decrease from baseline pain (39% vs 15% for placebo, P = .002). Pregabalin also significantly reduced sleep interference, past week and present pain intensity, sensory and affective pain scores, and bodily pain and decreased by > or =50% the number of patients describing their pain as gnawing, sickening, fearful, and punishing-cruel. More patients receiving pregabalin 600 mg/day than placebo showed improvement, as rated on the Clinical and Patient Global Impression of Change scales, 73% vs 45% and 85% vs 47%, respectively. Pregabalin 150 mg/day was essentially no different from placebo. Dizziness was the most common side effect. These study results show pregabalin 600 mg/day to be safe and effective in reducing the pain and other associated symptoms of painful diabetic neuropathy. PERSPECTIVE: Painful diabetic peripheral neuropathy is a challenging neuropathic pain syndrome. This randomized controlled trial demonstrates that pregabalin, a new drug that interacts with the alpha2-delta protein subunit of the voltage-gated calcium channel, is an efficacious and safe treatment for the pain of this condition. SN - 1526-5900 UR - https://www.unboundmedicine.com/medline/citation/15820913/Relief_of_painful_diabetic_peripheral_neuropathy_with_pregabalin:_a_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(05)00003-9 DB - PRIME DP - Unbound Medicine ER -