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The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial.

Abstract

OBJECTIVE

To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM).

METHODS

A 27-week, randomized, double-blind, multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM. Two composite responder definitions were used to classify each patient's individual response to therapy. "FM responders" concurrently satisfied response criteria for improvements in pain (visual analog scale 24-h morning recall), patient global impression of change (PGIC), and physical functioning (SF-36 Physical Component Summary); while "FM pain responders" concurrently satisfied response criteria for improvements in pain and PGIC.

RESULTS

At the primary endpoint, after 3-month stable dose treatment, a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo (milnacipran 200 mg/day, p = 0.017; milnacipran 100 mg/day, p = 0.028). A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo (p = 0.032). Significant pain reductions were observed after Week 1 with both milnacipran doses. At 15 weeks, milnacipran 200 mg/day led to significant improvements over placebo in pain (realtime, daily and weekly recall; all measures, p < 0.05), PGIC (p < 0.001), fatigue (p = 0.016), cognition (p = 0.025), and multiple SF-36 domains. Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment; nausea and headache were the most common adverse events.

CONCLUSION

Milnacipran is safe and effective for the treatment of multiple symptoms of FM.

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  • Authors+Show Affiliations

    ,

    Seattle Rheumatology Associates, 1101 Madison Street, Suite 1000, Seattle, WA 98104, USA. pmease@philipmease.com

    , , , , ,

    Source

    The Journal of rheumatology 36:2 2009 Feb pg 398-409

    MeSH

    Adrenergic Uptake Inhibitors
    Adult
    Cognition Disorders
    Cyclopropanes
    Dose-Response Relationship, Drug
    Double-Blind Method
    Drug Administration Schedule
    Fatigue Syndrome, Chronic
    Female
    Fibromyalgia
    Headache
    Humans
    Male
    Middle Aged
    Milnacipran
    Muscle, Skeletal
    Nausea
    Pain Measurement
    Placebos
    Serotonin Uptake Inhibitors
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    19132781

    Citation

    Mease, Philip J., et al. "The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. a Randomized, Double-blind, Placebo-controlled Trial." The Journal of Rheumatology, vol. 36, no. 2, 2009, pp. 398-409.
    Mease PJ, Clauw DJ, Gendreau RM, et al. The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009;36(2):398-409.
    Mease, P. J., Clauw, D. J., Gendreau, R. M., Rao, S. G., Kranzler, J., Chen, W., & Palmer, R. H. (2009). The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. The Journal of Rheumatology, 36(2), pp. 398-409. doi:10.3899/jrheum.080734.
    Mease PJ, et al. The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. a Randomized, Double-blind, Placebo-controlled Trial. J Rheumatol. 2009;36(2):398-409. PubMed PMID: 19132781.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. AU - Mease,Philip J, AU - Clauw,Daniel J, AU - Gendreau,R Michael, AU - Rao,Srinivas G, AU - Kranzler,Jay, AU - Chen,Wei, AU - Palmer,Robert H, PY - 2009/1/10/entrez PY - 2009/1/10/pubmed PY - 2009/4/22/medline SP - 398 EP - 409 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 36 IS - 2 N2 - OBJECTIVE: To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM). METHODS: A 27-week, randomized, double-blind, multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM. Two composite responder definitions were used to classify each patient's individual response to therapy. "FM responders" concurrently satisfied response criteria for improvements in pain (visual analog scale 24-h morning recall), patient global impression of change (PGIC), and physical functioning (SF-36 Physical Component Summary); while "FM pain responders" concurrently satisfied response criteria for improvements in pain and PGIC. RESULTS: At the primary endpoint, after 3-month stable dose treatment, a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo (milnacipran 200 mg/day, p = 0.017; milnacipran 100 mg/day, p = 0.028). A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo (p = 0.032). Significant pain reductions were observed after Week 1 with both milnacipran doses. At 15 weeks, milnacipran 200 mg/day led to significant improvements over placebo in pain (realtime, daily and weekly recall; all measures, p < 0.05), PGIC (p < 0.001), fatigue (p = 0.016), cognition (p = 0.025), and multiple SF-36 domains. Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment; nausea and headache were the most common adverse events. CONCLUSION: Milnacipran is safe and effective for the treatment of multiple symptoms of FM. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/19132781/full_citation L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&amp;pmid=19132781 DB - PRIME DP - Unbound Medicine ER -