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Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial.

Abstract

OBJECTIVE

This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with postherpetic neuralgia (PHN).

RESEARCH DESIGN AND METHODS

The 13-week, double-blind, placebo-controlled study randomized 370 patients with PHN to pregabalin (150, 300, or 600 mg/day BID) or placebo.

MAIN OUTCOME MEASURES

Primary efficacy measure was endpoint mean pain score from daily pain diaries. Secondary efficacy measures included endpoint mean sleep-interference score from daily sleep diaries and Patient Global Impression of Change (PGIC). Safety evaluations included adverse events (AEs), physical and neurologic examinations, 12-lead ECG, vital signs, and laboratory testing.

RESULTS

Pregabalin provided significant, dose-proportional pain relief at endpoint: difference from placebo in mean pain score, 150 mg/day, -0.88, p = 0.0077; 300 mg/day, -1.07, p = 0.0016; 600 mg/day, -1.79, p = 0.0003. Weekly mean pain scores significantly improved as early as week 1. Sleep interference in all pregabalin groups was also significantly improved at endpoint, compared with placebo (p < 0.001), beginning at week 1 (p < 0.01). At study termination, patients in the 150 (p = 0.02) and 600 mg/day (p = 0.003) groups were more likely to report global improvement than were those in the placebo group. Most AEs were mild or moderate. Among pregabalin-treated patients, 13.5% withdrew due to AEs, most commonly for dizziness (16 patients, 5.8%), somnolence (8, 2.9%), or ataxia (7, 2.5%).

CONCLUSIONS

Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated. It also reduced the extent to which pain interfered with sleep. Pregabalin's effects were seen as early as week 1 and were sustained throughout the 13-week study.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Amphia Ziekenhuis, Department of Anaesthesiology, The Netherlands. 7ster@planet.nl

    , , , ,

    Source

    Current medical research and opinion 22:2 2006 Feb pg 375-84

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Double-Blind Method
    Drug-Related Side Effects and Adverse Reactions
    Female
    Humans
    Male
    Middle Aged
    Neuralgia, Postherpetic
    Placebos
    Pregabalin
    Sleep Wake Disorders
    Treatment Outcome
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16466610

    Citation

    van Seventer, Robert, et al. "Efficacy and Tolerability of Twice-daily Pregabalin for Treating Pain and Related Sleep Interference in Postherpetic Neuralgia: a 13-week, Randomized Trial." Current Medical Research and Opinion, vol. 22, no. 2, 2006, pp. 375-84.
    van Seventer R, Feister HA, Young JP, et al. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin. 2006;22(2):375-84.
    van Seventer, R., Feister, H. A., Young, J. P., Stoker, M., Versavel, M., & Rigaudy, L. (2006). Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Current Medical Research and Opinion, 22(2), pp. 375-84.
    van Seventer R, et al. Efficacy and Tolerability of Twice-daily Pregabalin for Treating Pain and Related Sleep Interference in Postherpetic Neuralgia: a 13-week, Randomized Trial. Curr Med Res Opin. 2006;22(2):375-84. PubMed PMID: 16466610.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. AU - van Seventer,Robert, AU - Feister,Hilary A, AU - Young,James P,Jr AU - Stoker,Malcolm, AU - Versavel,Mark, AU - Rigaudy,Laurence, PY - 2006/2/10/pubmed PY - 2006/4/18/medline PY - 2006/2/10/entrez SP - 375 EP - 84 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 2 N2 - OBJECTIVE: This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with postherpetic neuralgia (PHN). RESEARCH DESIGN AND METHODS: The 13-week, double-blind, placebo-controlled study randomized 370 patients with PHN to pregabalin (150, 300, or 600 mg/day BID) or placebo. MAIN OUTCOME MEASURES: Primary efficacy measure was endpoint mean pain score from daily pain diaries. Secondary efficacy measures included endpoint mean sleep-interference score from daily sleep diaries and Patient Global Impression of Change (PGIC). Safety evaluations included adverse events (AEs), physical and neurologic examinations, 12-lead ECG, vital signs, and laboratory testing. RESULTS: Pregabalin provided significant, dose-proportional pain relief at endpoint: difference from placebo in mean pain score, 150 mg/day, -0.88, p = 0.0077; 300 mg/day, -1.07, p = 0.0016; 600 mg/day, -1.79, p = 0.0003. Weekly mean pain scores significantly improved as early as week 1. Sleep interference in all pregabalin groups was also significantly improved at endpoint, compared with placebo (p < 0.001), beginning at week 1 (p < 0.01). At study termination, patients in the 150 (p = 0.02) and 600 mg/day (p = 0.003) groups were more likely to report global improvement than were those in the placebo group. Most AEs were mild or moderate. Among pregabalin-treated patients, 13.5% withdrew due to AEs, most commonly for dizziness (16 patients, 5.8%), somnolence (8, 2.9%), or ataxia (7, 2.5%). CONCLUSIONS: Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated. It also reduced the extent to which pain interfered with sleep. Pregabalin's effects were seen as early as week 1 and were sustained throughout the 13-week study. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/16466610/Efficacy_and_tolerability_of_twice_daily_pregabalin_for_treating_pain_and_related_sleep_interference_in_postherpetic_neuralgia:_a_13_week_randomized_trial_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X80404 DB - PRIME DP - Unbound Medicine ER -