Effect of duloxetine in patients with fibromyalgia: Tiredness subgroups

Laurence A. Bradley, Robert (Rob) Bennett, Irwin J. Russell, Madelaine M. Wohlreich, Amy S. Chappell, Fujun Wang, Deborah N. D'Souza, Harvey Moldofsky

    Research output: Contribution to journalArticle

    4 Citations (Scopus)

    Abstract

    Introduction: This study tested the hypothesis that baseline ratings of fatigue/tiredness would be negatively associated with the efficacy of duloxetine on measures of pain and functional ability in patients with fibromyalgia.Methods: A post hoc analysis of pooled data from 4 double-blind, placebo-controlled studies of duloxetine in fibromyalgia was performed. The fibromyalgia impact questionnaire (FIQ) tiredness item score (0 to 10 scale) was used to define tiredness subgroups. Patients were stratified into 3 subgroups: mild (0 to 3), moderate (4 to 6), and severe (7 to 10) tiredness. Analysis of covariance models and logistic regressions were used to test treatment-by-tiredness subgroup interactions.Results: Data from the first 3 months are included in this post hoc analysis (duloxetine N = 797, placebo N = 535). At baseline, the distribution of tiredness severity in the duloxetine and placebo groups respectively was 3.64% and 3.75% mild, 16.71% and 15.57% moderate, and 79.65% and 80.68% severe. Rates of clinically significant (≥30% and ≥50%) improvement in brief pain inventory (BPI) average pain were similar across the tiredness subgroups. Tiredness severity at baseline was not negatively associated with the effects of duloxetine on patients' reports of functional ability using the FIQ total score, FIQ measures of physical impairment, interference with work, pain, stiffness, and depression and the medical outcomes study short form-36 (SF-36).Conclusions: Studies of duloxetine in fibromyalgia have demonstrated clinically significant improvements in pain and functional ability (FIQ, SF-36). This post hoc analysis of data shows that the efficacy of duloxetine among patients with fibromyalgia does not vary as a function of baseline ratings of fatigue/tiredness.

    Original languageEnglish (US)
    Article numberR141
    JournalArthritis Research and Therapy
    Volume12
    Issue number4
    DOIs
    StatePublished - Jul 14 2010

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    Fibromyalgia
    Aptitude
    Pain
    Placebos
    Fatigue
    Duloxetine Hydrochloride
    Logistic Models
    Outcome Assessment (Health Care)
    Depression
    Equipment and Supplies
    Surveys and Questionnaires

    ASJC Scopus subject areas

    • Rheumatology
    • Immunology
    • Immunology and Allergy
    • Medicine(all)

    Cite this

    Bradley, L. A., Bennett, R. R., Russell, I. J., Wohlreich, M. M., Chappell, A. S., Wang, F., ... Moldofsky, H. (2010). Effect of duloxetine in patients with fibromyalgia: Tiredness subgroups. Arthritis Research and Therapy, 12(4), [R141]. https://doi.org/10.1186/ar3081

    Effect of duloxetine in patients with fibromyalgia : Tiredness subgroups. / Bradley, Laurence A.; Bennett, Robert (Rob); Russell, Irwin J.; Wohlreich, Madelaine M.; Chappell, Amy S.; Wang, Fujun; D'Souza, Deborah N.; Moldofsky, Harvey.

    In: Arthritis Research and Therapy, Vol. 12, No. 4, R141, 14.07.2010.

    Research output: Contribution to journalArticle

    Bradley, LA, Bennett, RR, Russell, IJ, Wohlreich, MM, Chappell, AS, Wang, F, D'Souza, DN & Moldofsky, H 2010, 'Effect of duloxetine in patients with fibromyalgia: Tiredness subgroups', Arthritis Research and Therapy, vol. 12, no. 4, R141. https://doi.org/10.1186/ar3081
    Bradley LA, Bennett RR, Russell IJ, Wohlreich MM, Chappell AS, Wang F et al. Effect of duloxetine in patients with fibromyalgia: Tiredness subgroups. Arthritis Research and Therapy. 2010 Jul 14;12(4). R141. https://doi.org/10.1186/ar3081
    Bradley, Laurence A. ; Bennett, Robert (Rob) ; Russell, Irwin J. ; Wohlreich, Madelaine M. ; Chappell, Amy S. ; Wang, Fujun ; D'Souza, Deborah N. ; Moldofsky, Harvey. / Effect of duloxetine in patients with fibromyalgia : Tiredness subgroups. In: Arthritis Research and Therapy. 2010 ; Vol. 12, No. 4.
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    abstract = "Introduction: This study tested the hypothesis that baseline ratings of fatigue/tiredness would be negatively associated with the efficacy of duloxetine on measures of pain and functional ability in patients with fibromyalgia.Methods: A post hoc analysis of pooled data from 4 double-blind, placebo-controlled studies of duloxetine in fibromyalgia was performed. The fibromyalgia impact questionnaire (FIQ) tiredness item score (0 to 10 scale) was used to define tiredness subgroups. Patients were stratified into 3 subgroups: mild (0 to 3), moderate (4 to 6), and severe (7 to 10) tiredness. Analysis of covariance models and logistic regressions were used to test treatment-by-tiredness subgroup interactions.Results: Data from the first 3 months are included in this post hoc analysis (duloxetine N = 797, placebo N = 535). At baseline, the distribution of tiredness severity in the duloxetine and placebo groups respectively was 3.64{\%} and 3.75{\%} mild, 16.71{\%} and 15.57{\%} moderate, and 79.65{\%} and 80.68{\%} severe. Rates of clinically significant (≥30{\%} and ≥50{\%}) improvement in brief pain inventory (BPI) average pain were similar across the tiredness subgroups. Tiredness severity at baseline was not negatively associated with the effects of duloxetine on patients' reports of functional ability using the FIQ total score, FIQ measures of physical impairment, interference with work, pain, stiffness, and depression and the medical outcomes study short form-36 (SF-36).Conclusions: Studies of duloxetine in fibromyalgia have demonstrated clinically significant improvements in pain and functional ability (FIQ, SF-36). This post hoc analysis of data shows that the efficacy of duloxetine among patients with fibromyalgia does not vary as a function of baseline ratings of fatigue/tiredness.",
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    AU - Bradley, Laurence A.

    AU - Bennett, Robert (Rob)

    AU - Russell, Irwin J.

    AU - Wohlreich, Madelaine M.

    AU - Chappell, Amy S.

    AU - Wang, Fujun

    AU - D'Souza, Deborah N.

    AU - Moldofsky, Harvey

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