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Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial.

Abstract

BACKGROUND

Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID) versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC).

METHODS

In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS) from daily pain diaries (11-point scale). NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment). At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving >or=50% reduction in MPS from baseline to endpoint). After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks.

RESULTS

Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and approximately 5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p <.001). For all four nerves, 95% CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 (ie, no significant difference vs. placebo). Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint. More pregabalin-treated patients (49%) than controls (23%) were responders (p <.001).

CONCLUSION

Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN.

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  • Authors+Show Affiliations

    ,

    Albert Einstein College of Medicine, New York, NY, USA. Arezzo@aecom.yu.edu

    , ,

    Source

    BMC neurology 8: 2008 Sep 16 pg 33

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Analgesics
    Diabetic Neuropathies
    Double-Blind Method
    Drug Administration Schedule
    Female
    Follow-Up Studies
    Humans
    Male
    Median Nerve
    Middle Aged
    Neural Conduction
    Pain
    Pain Measurement
    Peroneal Nerve
    Placebos
    Pregabalin
    Treatment Outcome
    Ulnar Nerve
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    18796160

    Citation

    Arezzo, Joseph C., et al. "Efficacy and Safety of Pregabalin 600 Mg/d for Treating Painful Diabetic Peripheral Neuropathy: a Double-blind Placebo-controlled Trial." BMC Neurology, vol. 8, 2008, p. 33.
    Arezzo JC, Rosenstock J, Lamoreaux L, et al. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurol. 2008;8:33.
    Arezzo, J. C., Rosenstock, J., Lamoreaux, L., & Pauer, L. (2008). Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurology, 8, p. 33. doi:10.1186/1471-2377-8-33.
    Arezzo JC, et al. Efficacy and Safety of Pregabalin 600 Mg/d for Treating Painful Diabetic Peripheral Neuropathy: a Double-blind Placebo-controlled Trial. BMC Neurol. 2008 Sep 16;8:33. PubMed PMID: 18796160.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. AU - Arezzo,Joseph C, AU - Rosenstock,Julio, AU - Lamoreaux,Linda, AU - Pauer,Lynne, Y1 - 2008/09/16/ PY - 2008/02/28/received PY - 2008/09/16/accepted PY - 2008/9/18/pubmed PY - 2008/12/17/medline PY - 2008/9/18/entrez SP - 33 EP - 33 JF - BMC neurology JO - BMC Neurol VL - 8 N2 - BACKGROUND: Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID) versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC). METHODS: In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS) from daily pain diaries (11-point scale). NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment). At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving >or=50% reduction in MPS from baseline to endpoint). After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks. RESULTS: Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and approximately 5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p <.001). For all four nerves, 95% CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 (ie, no significant difference vs. placebo). Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint. More pregabalin-treated patients (49%) than controls (23%) were responders (p <.001). CONCLUSION: Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN. SN - 1471-2377 UR - https://www.unboundmedicine.com/medline/citation/18796160/Efficacy_and_safety_of_pregabalin_600_mg/d_for_treating_painful_diabetic_peripheral_neuropathy:_a_double_blind_placebo_controlled_trial_ L2 - https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-8-33 DB - PRIME DP - Unbound Medicine ER -