Tags

Type your tag names separated by a space and hit enter

Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens.

Abstract

Pregabalin binds with high affinity to the alpha2-delta subunit protein of voltage-gated calcium channels and, thereby, reduces release of excitatory neurotransmitters. This 12-week randomised, double-blind, multicentre, placebo-controlled, parallel-group study evaluated the efficacy and safety of pregabalin in patients with chronic postherpetic neuralgia (PHN) or painful diabetic peripheral neuropathy (DPN). Patients were randomised to placebo (n=65) or to one of two pregabalin regimens: a flexible schedule of 150, 300, 450, and 600 mg/day with weekly dose escalation based on patients' individual responses and tolerability (n=141) or a fixed schedule of 300 mg/day for 1 week followed by 600 mg/day for 11 weeks (n=132). Both flexible- and fixed-dose pregabalin significantly reduced endpoint mean pain score (primary outcome) versus placebo (P=0.002, P<0.001) and were significantly superior to placebo in improving pain-related sleep interference (P<0.001). The most common adverse events (AEs) for pregabalin-treated patients were dizziness, peripheral oedema, weight gain (not affecting diabetes control), and somnolence. These results are consistent with previous studies' demonstrating pregabalin's efficacy, tolerability, and safety for treatment of chronic neuropathic pain associated with DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy and tolerability provides significant pain relief and may reduce risks for AEs and therapy discontinuation.

Links

  • Publisher Full Text
  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Klinik für Anaesthesiologie, Universitätsklinikum Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany. freynhagen@med.uni-duesseldorf.de

    , , ,

    Source

    Pain 115:3 2005 Jun pg 254-63

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Anticonvulsants
    Diabetic Neuropathies
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Neuralgia
    Placebos
    Pregabalin
    Sleep
    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

    15911152

    Citation

    Freynhagen, Rainer, et al. "Efficacy of Pregabalin in Neuropathic Pain Evaluated in a 12-week, Randomised, Double-blind, Multicentre, Placebo-controlled Trial of Flexible- and Fixed-dose Regimens." Pain, vol. 115, no. 3, 2005, pp. 254-63.
    Freynhagen R, Strojek K, Griesing T, et al. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain. 2005;115(3):254-63.
    Freynhagen, R., Strojek, K., Griesing, T., Whalen, E., & Balkenohl, M. (2005). Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain, 115(3), pp. 254-63.
    Freynhagen R, et al. Efficacy of Pregabalin in Neuropathic Pain Evaluated in a 12-week, Randomised, Double-blind, Multicentre, Placebo-controlled Trial of Flexible- and Fixed-dose Regimens. Pain. 2005;115(3):254-63. PubMed PMID: 15911152.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. AU - Freynhagen,Rainer, AU - Strojek,Krzysztof, AU - Griesing,Teresa, AU - Whalen,Ed, AU - Balkenohl,Michael, Y1 - 2005/04/18/ PY - 2004/10/17/received PY - 2005/02/15/revised PY - 2005/02/28/accepted PY - 2005/5/25/pubmed PY - 2005/7/29/medline PY - 2005/5/25/entrez SP - 254 EP - 63 JF - Pain JO - Pain VL - 115 IS - 3 N2 - Pregabalin binds with high affinity to the alpha2-delta subunit protein of voltage-gated calcium channels and, thereby, reduces release of excitatory neurotransmitters. This 12-week randomised, double-blind, multicentre, placebo-controlled, parallel-group study evaluated the efficacy and safety of pregabalin in patients with chronic postherpetic neuralgia (PHN) or painful diabetic peripheral neuropathy (DPN). Patients were randomised to placebo (n=65) or to one of two pregabalin regimens: a flexible schedule of 150, 300, 450, and 600 mg/day with weekly dose escalation based on patients' individual responses and tolerability (n=141) or a fixed schedule of 300 mg/day for 1 week followed by 600 mg/day for 11 weeks (n=132). Both flexible- and fixed-dose pregabalin significantly reduced endpoint mean pain score (primary outcome) versus placebo (P=0.002, P<0.001) and were significantly superior to placebo in improving pain-related sleep interference (P<0.001). The most common adverse events (AEs) for pregabalin-treated patients were dizziness, peripheral oedema, weight gain (not affecting diabetes control), and somnolence. These results are consistent with previous studies' demonstrating pregabalin's efficacy, tolerability, and safety for treatment of chronic neuropathic pain associated with DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy and tolerability provides significant pain relief and may reduce risks for AEs and therapy discontinuation. SN - 0304-3959 UR - https://www.unboundmedicine.com/medline/citation/15911152/Efficacy_of_pregabalin_in_neuropathic_pain_evaluated_in_a_12_week_randomised_double_blind_multicentre_placebo_controlled_trial_of_flexible__and_fixed_dose_regimens_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304-3959(05)00104-1 DB - PRIME DP - Unbound Medicine ER -