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Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial.

Abstract

OBJECTIVES

To date, published neuropathic pain randomized controlled trials of pregabalin have involved primarily diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). This multicenter trial evaluated pregabalin in a broader range of neuropathic pain etiologies.

METHODS

In this enriched enrollment randomized withdrawal trial, 256 patients received single blind, flexible dose pregabalin for 4 weeks; stable concomitant analgesics were allowed. One hundred sixty-five (65%) had a ≥30% pain improvement and 157 were randomized and treated, double blind, to either continue pregabalin (n=80) or to receive placebo (n=77) for 5 weeks.

RESULTS

Of the single blind responders randomized, 81% on placebo and 86% on pregabalin completed the double-blind phase. At the double-blind endpoint, mean (SD) pain scores were 2.9 (1.9) in the pregabalin group and 3.5 (1.7) in the placebo group (P=0.002). These modest yet significant pregabalin-placebo differences were observed within each of the subgroups of patients with a diagnosis of either DPN or PHN (P=0.03), and with other diagnoses (P=0.02). Significant differences were also observed in sleep interference, Hospital Anxiety and Depression Scale Anxiety and Depression subscales, and other secondary measures. In total, 28 out of 80 (35.0%) in the pregabalin group and 28 out of 77 (36.4%) in the placebo group had either a meaningful increase in pain or discontinued the double-blind phase. Adverse events were consistent with the known tolerability profile of pregabalin and led to discontinuation of 9 during the single-blind phase, and 5 and 2 patients from the placebo and pregabalin groups, respectively.

DISCUSSION

These results support previous evidence of pregabalin efficacy but further demonstrate efficacy and tolerability in a broader range of peripheral neuropathic pain conditions beyond just DPN and PHN.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Anesthesiology, Queen's University, Kingston, Ontario, Canada. gilroni@post.queensu.ca

    , ,

    Source

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Analgesics
    Canada
    Drug Administration Schedule
    Female
    Humans
    Male
    Middle Aged
    Neuralgia
    Pain Measurement
    Placebo Effect
    Pregabalin
    Single-Blind Method
    Treatment Outcome
    Young Adult
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    21178603

    Citation

    Gilron, Ian, et al. "Pregabalin for Peripheral Neuropathic Pain: a Multicenter, Enriched Enrollment Randomized Withdrawal Placebo-controlled Trial." The Clinical Journal of Pain, vol. 27, no. 3, 2011, pp. 185-93.
    Gilron I, Wajsbrot D, Therrien F, et al. Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. Clin J Pain. 2011;27(3):185-93.
    Gilron, I., Wajsbrot, D., Therrien, F., & Lemay, J. (2011). Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. The Clinical Journal of Pain, 27(3), pp. 185-93. doi:10.1097/AJP.0b013e3181fe13f6.
    Gilron I, et al. Pregabalin for Peripheral Neuropathic Pain: a Multicenter, Enriched Enrollment Randomized Withdrawal Placebo-controlled Trial. Clin J Pain. 2011;27(3):185-93. PubMed PMID: 21178603.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. AU - Gilron,Ian, AU - Wajsbrot,Dalia, AU - Therrien,François, AU - Lemay,Jacinthe, PY - 2010/12/24/entrez PY - 2010/12/24/pubmed PY - 2011/6/3/medline SP - 185 EP - 93 JF - The Clinical journal of pain JO - Clin J Pain VL - 27 IS - 3 N2 - OBJECTIVES: To date, published neuropathic pain randomized controlled trials of pregabalin have involved primarily diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). This multicenter trial evaluated pregabalin in a broader range of neuropathic pain etiologies. METHODS: In this enriched enrollment randomized withdrawal trial, 256 patients received single blind, flexible dose pregabalin for 4 weeks; stable concomitant analgesics were allowed. One hundred sixty-five (65%) had a ≥30% pain improvement and 157 were randomized and treated, double blind, to either continue pregabalin (n=80) or to receive placebo (n=77) for 5 weeks. RESULTS: Of the single blind responders randomized, 81% on placebo and 86% on pregabalin completed the double-blind phase. At the double-blind endpoint, mean (SD) pain scores were 2.9 (1.9) in the pregabalin group and 3.5 (1.7) in the placebo group (P=0.002). These modest yet significant pregabalin-placebo differences were observed within each of the subgroups of patients with a diagnosis of either DPN or PHN (P=0.03), and with other diagnoses (P=0.02). Significant differences were also observed in sleep interference, Hospital Anxiety and Depression Scale Anxiety and Depression subscales, and other secondary measures. In total, 28 out of 80 (35.0%) in the pregabalin group and 28 out of 77 (36.4%) in the placebo group had either a meaningful increase in pain or discontinued the double-blind phase. Adverse events were consistent with the known tolerability profile of pregabalin and led to discontinuation of 9 during the single-blind phase, and 5 and 2 patients from the placebo and pregabalin groups, respectively. DISCUSSION: These results support previous evidence of pregabalin efficacy but further demonstrate efficacy and tolerability in a broader range of peripheral neuropathic pain conditions beyond just DPN and PHN. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/21178603/Pregabalin_for_peripheral_neuropathic_pain:_a_multicenter_enriched_enrollment_randomized_withdrawal_placebo_controlled_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=21178603 DB - PRIME DP - Unbound Medicine ER -