Durability of Therapeutic Response to Milnacipran Treatment for Fibromyalgia. Results of a Randomized, Double-Blind, Monotherapy 6-Month Extension Study

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dc.contributor.author Goldenberg, Don L. en_US
dc.contributor.author Clauw, Daniel J. en_US
dc.contributor.author Palmer, Robert H. en_US
dc.contributor.author Mease, Philip en_US
dc.contributor.author Chen, Wei en_US
dc.contributor.author Gendreau, R. michael en_US
dc.date.accessioned 2011-01-13T19:40:26Z
dc.date.available 2011-01-13T19:40:26Z
dc.date.issued 2010-02 en_US
dc.identifier.citation Goldenberg, Don L.; Clauw, Daniel J.; Palmer, Robert H.; Mease, Philip; Chen, Wei; Gendreau, R. michael; (2010). "Durability of Therapeutic Response to Milnacipran Treatment for Fibromyalgia. Results of a Randomized, Double-Blind, Monotherapy 6-Month Extension Study." Pain Medicine 11(2): 180-194. <http://hdl.handle.net/2027.42/78636> en_US
dc.identifier.issn 1526-2375 en_US
dc.identifier.issn 1526-4637 en_US
dc.identifier.uri http://hdl.handle.net/2027.42/78636
dc.description.abstract To evaluate the durability of improvement and long-term efficacy of milnacipran treatment in fibromyalgia, to assess efficacy in patients re-randomized from placebo to milnacipran, and to collect additional information on the tolerability and efficacy of long-term treatment with milnacipran.A total of 449 patients who successfully completed a 6-month lead-in study enrolled in this 6-month extension study (87.7% of eligible subjects). Patients initially receiving milnacipran 200 mg/day during the lead-in study were maintained at 200 mg/day (n = 209); patients initially assigned to placebo or milnacipran 100 mg/day were re-randomized (1:4) to either 100 mg/day (n = 48) or 200 mg/day (n = 192) of milnacipran for an additional 6 months of treatment. Efficacy assessments included visual analog scale pain ratings, Fibromyalgia Impact Questionnaire (FIQ) total score, and Patient Global Impression of Change (PGIC).Patients continuing on milnacipran demonstrated a sustained reduction in pain over the full 12-month period. Additional beneficial effects were also maintained, as indicated by the PGIC and FIQ. Patients initially assigned to either placebo or milnacipran 100 mg/day in the lead-in study and subsequently re-randomized to milnacipran 200 mg/day in the extension study experienced further improvements in their mean pain scores, FIQ total scores, and PGIC ratings at 1 year. Milnacipran treatment was generally well tolerated. The most commonly reported newly emergent adverse event was nausea.In addition to confirming that milnacipran safely and effectively improves the multiple symptoms of fibromyalgia, these data indicate that milnacipran provides 1-year durable efficacy in this patient population. en_US
dc.format.extent 553119 bytes
dc.format.extent 3106 bytes
dc.format.mimetype application/pdf
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dc.publisher Blackwell Publishing Inc en_US
dc.subject.other Fibromyalgia en_US
dc.subject.other Milnacipran en_US
dc.subject.other Serotonin-Norepinephrine Reuptake Inhibitor en_US
dc.subject.other Pain en_US
dc.subject.other Analgesic en_US
dc.subject.other Long Term en_US
dc.title Durability of Therapeutic Response to Milnacipran Treatment for Fibromyalgia. Results of a Randomized, Double-Blind, Monotherapy 6-Month Extension Study en_US
dc.rights.robots IndexNoFollow en_US
dc.subject.hlbsecondlevel Medicine (General) en_US
dc.subject.hlbtoplevel Health Sciences en_US
dc.description.peerreviewed Peer Reviewed en_US
dc.contributor.affiliationum Department of Anesthesiology and Medicine, University of Michigan Medical School, Ann Arbor, Michigan en_US
dc.contributor.affiliationother Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts en_US
dc.contributor.affiliationother Forest Research Institute, Jersey City, New Jersey en_US
dc.contributor.affiliationother Seattle Rheumatology Associates, Seattle, Washington en_US
dc.contributor.affiliationother Cypress Bioscience, Inc., San Diego, California, USA en_US
dc.identifier.pmid 20002596 en_US
dc.description.bitstreamurl http://deepblue.lib.umich.edu/bitstream/2027.42/78636/1/j.1526-4637.2009.00755.x.pdf
dc.identifier.doi 10.1111/j.1526-4637.2009.00755.x en_US
dc.identifier.source Pain Medicine en_US
dc.owningcollname Interdisciplinary and Peer-Reviewed
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