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Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial.

Abstract

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 8-week trial (with subsequent open-label phase) evaluated the effectiveness of pregabalin in alleviating pain associated with diabetic peripheral neuropathy (DPN). For enrollment, patients must have had at baseline: 1- to 5-year history of DPN pain; pain score > or =40 mm (Short-Form McGill Pain Questionnaire [SF-MPQ] visual analogue scale); average daily pain score of > or =4 (11-point numerical pain rating scale [0 = no pain, 10 = worst possible pain]). One hundred forty-six (146) patients were randomized to receive placebo (n = 70) or pregabalin 300 mg/day (n = 76). Primary efficacy measure was endpoint mean pain score from daily patient diaries (11-point numerical pain rating scale). Secondary measures included SF-MPQ scores; sleep interference scores; Patient and Clinical Global Impression of Change (PGIC and CGIC); Short Form-36 (SF-36) Health Survey scores; and Profile of Mood States (POMS) scores. Safety assessment included incidence and intensity of adverse events, physical and neurological examinations, and laboratory evaluations. Pregabalin produced significant improvements versus placebo for mean pain scores (P < 0.0001); mean sleep interference scores SF-36 Bodily Pain subscale (P < 0.0001); total SF-MPQ score (P < 0.01); SF-36 Bodily Pain subscale (P < 0.03); PGIC (P = 0.001); and Total Mood Disturbance and Tension-Anxiety components of POMS (P < 0.03). Pain relief and improved sleep began during week 1 and remained significant throughout the study (P < 0.01). Pregabalin was well tolerated despite a greater incidence of dizziness and somnolence than placebo. Most adverse events were mild to moderate and did not result in withdrawal. Pregabalin was safe and effective in decreasing pain associated with DPN, and also improved mood, sleep disturbance, and quality of life.

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  • Authors+Show Affiliations

    ,

    Dallas Diabetes & Endo Research Center, 7777 Forest Lane, C618, Dallas, TX 75230, USA. juliorosenstock@dallasdiabetes.com

    , ,

    Source

    Pain 110:3 2004 Aug pg 628-38

    MeSH

    Adolescent
    Adult
    Aged
    Confidence Intervals
    Diabetic Neuropathies
    Double-Blind Method
    Female
    Humans
    Least-Squares Analysis
    Male
    Middle Aged
    Pain Measurement
    Pregabalin
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    15288403

    Citation

    Rosenstock, Julio, et al. "Pregabalin for the Treatment of Painful Diabetic Peripheral Neuropathy: a Double-blind, Placebo-controlled Trial." Pain, vol. 110, no. 3, 2004, pp. 628-38.
    Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110(3):628-38.
    Rosenstock, J., Tuchman, M., LaMoreaux, L., & Sharma, U. (2004). Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain, 110(3), pp. 628-38.
    Rosenstock J, et al. Pregabalin for the Treatment of Painful Diabetic Peripheral Neuropathy: a Double-blind, Placebo-controlled Trial. Pain. 2004;110(3):628-38. PubMed PMID: 15288403.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. AU - Rosenstock,Julio, AU - Tuchman,Michael, AU - LaMoreaux,Linda, AU - Sharma,Uma, PY - 2003/11/20/received PY - 2004/04/06/revised PY - 2004/05/03/accepted PY - 2004/8/4/pubmed PY - 2004/11/9/medline PY - 2004/8/4/entrez SP - 628 EP - 38 JF - Pain JO - Pain VL - 110 IS - 3 N2 - A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 8-week trial (with subsequent open-label phase) evaluated the effectiveness of pregabalin in alleviating pain associated with diabetic peripheral neuropathy (DPN). For enrollment, patients must have had at baseline: 1- to 5-year history of DPN pain; pain score > or =40 mm (Short-Form McGill Pain Questionnaire [SF-MPQ] visual analogue scale); average daily pain score of > or =4 (11-point numerical pain rating scale [0 = no pain, 10 = worst possible pain]). One hundred forty-six (146) patients were randomized to receive placebo (n = 70) or pregabalin 300 mg/day (n = 76). Primary efficacy measure was endpoint mean pain score from daily patient diaries (11-point numerical pain rating scale). Secondary measures included SF-MPQ scores; sleep interference scores; Patient and Clinical Global Impression of Change (PGIC and CGIC); Short Form-36 (SF-36) Health Survey scores; and Profile of Mood States (POMS) scores. Safety assessment included incidence and intensity of adverse events, physical and neurological examinations, and laboratory evaluations. Pregabalin produced significant improvements versus placebo for mean pain scores (P < 0.0001); mean sleep interference scores SF-36 Bodily Pain subscale (P < 0.0001); total SF-MPQ score (P < 0.01); SF-36 Bodily Pain subscale (P < 0.03); PGIC (P = 0.001); and Total Mood Disturbance and Tension-Anxiety components of POMS (P < 0.03). Pain relief and improved sleep began during week 1 and remained significant throughout the study (P < 0.01). Pregabalin was well tolerated despite a greater incidence of dizziness and somnolence than placebo. Most adverse events were mild to moderate and did not result in withdrawal. Pregabalin was safe and effective in decreasing pain associated with DPN, and also improved mood, sleep disturbance, and quality of life. SN - 0304-3959 UR - https://www.unboundmedicine.com/medline/citation/15288403/Pregabalin_for_the_treatment_of_painful_diabetic_peripheral_neuropathy:_a_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304395904002465 DB - PRIME DP - Unbound Medicine ER -