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An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of pregabalin monotherapy versus placebo for symptomatic pain relief and improvement of patient global assessment in patients with fibromyalgia (FM) enrolled from countries outside the United States.

METHODS

This international, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks. Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC). Secondary outcomes included assessments of sleep and function.

RESULTS

Patients in the 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (-0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score -5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227). Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day. Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups. All pregabalin doses demonstrated superiority to placebo on the Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and the Sleep Quality diary. Dizziness and somnolence were the most frequently reported adverse events.

CONCLUSION

Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866).

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  • Authors+Show Affiliations

    ,

    Pfizer Global Research and Development, Groton, CT 06340, USA. lynne.pauer@pfizer.com

    , , , , , , ,

    Source

    The Journal of rheumatology 38:12 2011 Dec pg 2643-52

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Analgesics
    Double-Blind Method
    Female
    Fibromyalgia
    Humans
    Male
    Middle Aged
    Placebos
    Pregabalin
    Sleep
    Sleep Wake Disorders
    Surveys and Questionnaires
    Treatment Outcome
    Young Adult
    gamma-Aminobutyric Acid

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    21965636

    Citation

    Pauer, Lynne, et al. "An International, Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin Monotherapy in Treatment of Patients With Fibromyalgia." The Journal of Rheumatology, vol. 38, no. 12, 2011, pp. 2643-52.
    Pauer L, Winkelmann A, Arsenault P, et al. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol. 2011;38(12):2643-52.
    Pauer, L., Winkelmann, A., Arsenault, P., Jespersen, A., Whelan, L., Atkinson, G., ... Zeiher, B. (2011). An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. The Journal of Rheumatology, 38(12), pp. 2643-52. doi:10.3899/jrheum.110569.
    Pauer L, et al. An International, Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin Monotherapy in Treatment of Patients With Fibromyalgia. J Rheumatol. 2011;38(12):2643-52. PubMed PMID: 21965636.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. AU - Pauer,Lynne, AU - Winkelmann,Andreas, AU - Arsenault,Pierre, AU - Jespersen,Anders, AU - Whelan,Laurence, AU - Atkinson,Gary, AU - Leon,Teresa, AU - Zeiher,Bernhardt, AU - ,, Y1 - 2011/10/01/ PY - 2011/10/4/entrez PY - 2011/10/4/pubmed PY - 2012/4/25/medline SP - 2643 EP - 52 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 38 IS - 12 N2 - OBJECTIVE: To evaluate the efficacy and safety of pregabalin monotherapy versus placebo for symptomatic pain relief and improvement of patient global assessment in patients with fibromyalgia (FM) enrolled from countries outside the United States. METHODS: This international, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks. Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC). Secondary outcomes included assessments of sleep and function. RESULTS: Patients in the 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (-0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score -5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227). Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day. Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups. All pregabalin doses demonstrated superiority to placebo on the Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and the Sleep Quality diary. Dizziness and somnolence were the most frequently reported adverse events. CONCLUSION: Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866). SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/21965636/An_international_randomized_double_blind_placebo_controlled_phase_III_trial_of_pregabalin_monotherapy_in_treatment_of_patients_with_fibromyalgia_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&pmid=21965636 DB - PRIME DP - Unbound Medicine ER -