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The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial.
J Rheumatol 2009; 36(2):398-409JR

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.

Authors+Show Affiliations

Seattle Rheumatology Associates, 1101 Madison Street, Suite 1000, Seattle, WA 98104, USA. pmease@philipmease.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 -